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Virtual reality an ‘exciting opportunity’ for geriatric psychiatry
Researchers are increasingly turning their attention to virtual reality (VR) for the treatment of psychiatric disorders in older adults.
Recent studies have highlighted the usefulness of VR in treating depression and loneliness in older patients who may be socially isolated because of their age, comorbidities, or the COVID-19 pandemic.
“The unique capability of virtual reality to create an immersive and engaging setting is an exciting opportunity for geriatric psychiatry,” Harmehr Sekhon, PhD, postdoctoral research fellow, Lady Davis Institute/Jewish General Hospital, McGill University, Montreal, and McLean Hospital, Harvard Medical School, Boston, told this news organization.
, Dr. Sekhon said.
One novel approach involves using VR to administer a mindfulness intervention in older adults. Dr. Sekhon shared information on her own mindfulness study and on other developments in VR and telemedicine at the American Association for Geriatric Psychiatry annual meeting.
Potential bridging tool
As the population ages, the prevalence of mental health disorders increases. Telemedicine has proved to be a potential “bridge” to address the health care needs of older adults, Dr. Sekhon noted.
She cited her systematic review of telemedicine for older adults with dementia during COVID-19. Results showed that telemedicine was a “beneficial approach” to assisting these individuals and that it increased accessibility, said Dr. Sekhon.
In addition, a survey published last year showed that 87% of Americans in general want to continue using telehealth services after the pandemic. Most respondents agreed that telehealth had made it easier to get the care they needed. They also reported having received the same level of care via telehealth as with in-person care.
A growing body of research shows that VR has “positive influences on mood and well-being, cognition, pain management, [and] treatment of phobias in younger adults,” Dr. Sekhon said. She added that there is evidence that VR is feasible for older adults, with applications in cognitive disorders.
She cited a recent systematic review of 55 studies that assessed the impact of different types of VR on mental health in older adults. The results showed that VR could be helpful in screening for cognitive impairment – and it was comparable to some paper-based assessment. It was also useful as a training tool for those with cognitive impairment.
Examples of VR interventions that can be used to treat cognitive impairment include “virtual cities, kitchens, supermarkets,” Dr. Sekhon noted.
The technology is increasingly being used as a tool to deliver psychotherapy, in which patient engagement is “a key determinant” of outcomes, she added. “Virtual reality is a cutting-edge, engaging, and immersive technique to administer psychotherapy,” she said.
Such VR approaches are proving successful in older patients. Dr. Sekhon highlighted the case of an 85-year-old woman who engaged in ten sessions of psychodynamic psychotherapy that targeted persistent dysthymia and negativistic mood. The case was part of a proof-of-concept study published in the May issue of the American Journal of Geriatric Psychiatry.
Dr. Sekhon noted the intervention was well tolerated and was associated with minimal side effects.
VR-based meditation
Dr. Sekhon and her colleagues are now conducting a randomized controlled trial of VR meditation in older adults. VR-based meditation has been shown to increase relaxation and to decrease anxiety, sadness, and anger in younger adults. However, it has not been studied in the geriatric population.
The pilot study is assessing the feasibility and tolerability of VR meditation for older adults and its effects on stress, anxiety, depression, sleep, and quality of life. The study involves 30 adults aged 60 years and older.
Participants receive either 15-minute VR mindfulness meditation sessions twice a week for 4 weeks or are on a control wait list. The meditation sessions are user friendly and focus on breath meditation and body scans, Dr. Sekhon reported.
Because participants are older and balance is a concern, safety steps are incorporated into the sessions. “We ensure they’re doing this in a seated position, in a chair with arm rests, so that they’re very stable and there’s no risk of falls,” said Dr. Sekhon.
Another concern with VR is motion sickness, she noted. “It’s pretty minimal, but the best way we found so far is giving older adults time to adapt and feel comfortable with the VR,” she said. From the first session, participants learn how to put on the device and are checked to make sure they are comfortable with the process. To help them get used to everything, video and audio are not included during the first session.
Dr. Sekhon noted that results from the study are expected later this year.
In addition to mindfulness, researchers are using VR to deliver other established interventions, such as exposure therapy – and are implementing these approaches in varied environments, including long-term and palliative care settings.
VR-related technology is constantly improving and is becoming easier to use and more affordable, said Dr. Sekhon. She noted that the simplest devices that rely on smartphones cost as little as $15.
Although VR in older adults is promising, there are barriers to its adoption and use in research, she noted. For example, older adults may have cognitive, visual, or hearing impairments. They may have limited digital literacy, and/or they may not have access to the required technology.
These barriers can be overcome through workarounds, including providing instructional videos and digital literacy assistance via Zoom and working with community partners to facilitate study recruitment of older patients, Dr. Sekhon said.
Dr. Sekhon’s research is funded by the Canadian Institutes of Health Research and the Fonds de recherche du Quebec Sante.
A version of this article first appeared on Medscape.com.
Researchers are increasingly turning their attention to virtual reality (VR) for the treatment of psychiatric disorders in older adults.
Recent studies have highlighted the usefulness of VR in treating depression and loneliness in older patients who may be socially isolated because of their age, comorbidities, or the COVID-19 pandemic.
“The unique capability of virtual reality to create an immersive and engaging setting is an exciting opportunity for geriatric psychiatry,” Harmehr Sekhon, PhD, postdoctoral research fellow, Lady Davis Institute/Jewish General Hospital, McGill University, Montreal, and McLean Hospital, Harvard Medical School, Boston, told this news organization.
, Dr. Sekhon said.
One novel approach involves using VR to administer a mindfulness intervention in older adults. Dr. Sekhon shared information on her own mindfulness study and on other developments in VR and telemedicine at the American Association for Geriatric Psychiatry annual meeting.
Potential bridging tool
As the population ages, the prevalence of mental health disorders increases. Telemedicine has proved to be a potential “bridge” to address the health care needs of older adults, Dr. Sekhon noted.
She cited her systematic review of telemedicine for older adults with dementia during COVID-19. Results showed that telemedicine was a “beneficial approach” to assisting these individuals and that it increased accessibility, said Dr. Sekhon.
In addition, a survey published last year showed that 87% of Americans in general want to continue using telehealth services after the pandemic. Most respondents agreed that telehealth had made it easier to get the care they needed. They also reported having received the same level of care via telehealth as with in-person care.
A growing body of research shows that VR has “positive influences on mood and well-being, cognition, pain management, [and] treatment of phobias in younger adults,” Dr. Sekhon said. She added that there is evidence that VR is feasible for older adults, with applications in cognitive disorders.
She cited a recent systematic review of 55 studies that assessed the impact of different types of VR on mental health in older adults. The results showed that VR could be helpful in screening for cognitive impairment – and it was comparable to some paper-based assessment. It was also useful as a training tool for those with cognitive impairment.
Examples of VR interventions that can be used to treat cognitive impairment include “virtual cities, kitchens, supermarkets,” Dr. Sekhon noted.
The technology is increasingly being used as a tool to deliver psychotherapy, in which patient engagement is “a key determinant” of outcomes, she added. “Virtual reality is a cutting-edge, engaging, and immersive technique to administer psychotherapy,” she said.
Such VR approaches are proving successful in older patients. Dr. Sekhon highlighted the case of an 85-year-old woman who engaged in ten sessions of psychodynamic psychotherapy that targeted persistent dysthymia and negativistic mood. The case was part of a proof-of-concept study published in the May issue of the American Journal of Geriatric Psychiatry.
Dr. Sekhon noted the intervention was well tolerated and was associated with minimal side effects.
VR-based meditation
Dr. Sekhon and her colleagues are now conducting a randomized controlled trial of VR meditation in older adults. VR-based meditation has been shown to increase relaxation and to decrease anxiety, sadness, and anger in younger adults. However, it has not been studied in the geriatric population.
The pilot study is assessing the feasibility and tolerability of VR meditation for older adults and its effects on stress, anxiety, depression, sleep, and quality of life. The study involves 30 adults aged 60 years and older.
Participants receive either 15-minute VR mindfulness meditation sessions twice a week for 4 weeks or are on a control wait list. The meditation sessions are user friendly and focus on breath meditation and body scans, Dr. Sekhon reported.
Because participants are older and balance is a concern, safety steps are incorporated into the sessions. “We ensure they’re doing this in a seated position, in a chair with arm rests, so that they’re very stable and there’s no risk of falls,” said Dr. Sekhon.
Another concern with VR is motion sickness, she noted. “It’s pretty minimal, but the best way we found so far is giving older adults time to adapt and feel comfortable with the VR,” she said. From the first session, participants learn how to put on the device and are checked to make sure they are comfortable with the process. To help them get used to everything, video and audio are not included during the first session.
Dr. Sekhon noted that results from the study are expected later this year.
In addition to mindfulness, researchers are using VR to deliver other established interventions, such as exposure therapy – and are implementing these approaches in varied environments, including long-term and palliative care settings.
VR-related technology is constantly improving and is becoming easier to use and more affordable, said Dr. Sekhon. She noted that the simplest devices that rely on smartphones cost as little as $15.
Although VR in older adults is promising, there are barriers to its adoption and use in research, she noted. For example, older adults may have cognitive, visual, or hearing impairments. They may have limited digital literacy, and/or they may not have access to the required technology.
These barriers can be overcome through workarounds, including providing instructional videos and digital literacy assistance via Zoom and working with community partners to facilitate study recruitment of older patients, Dr. Sekhon said.
Dr. Sekhon’s research is funded by the Canadian Institutes of Health Research and the Fonds de recherche du Quebec Sante.
A version of this article first appeared on Medscape.com.
Researchers are increasingly turning their attention to virtual reality (VR) for the treatment of psychiatric disorders in older adults.
Recent studies have highlighted the usefulness of VR in treating depression and loneliness in older patients who may be socially isolated because of their age, comorbidities, or the COVID-19 pandemic.
“The unique capability of virtual reality to create an immersive and engaging setting is an exciting opportunity for geriatric psychiatry,” Harmehr Sekhon, PhD, postdoctoral research fellow, Lady Davis Institute/Jewish General Hospital, McGill University, Montreal, and McLean Hospital, Harvard Medical School, Boston, told this news organization.
, Dr. Sekhon said.
One novel approach involves using VR to administer a mindfulness intervention in older adults. Dr. Sekhon shared information on her own mindfulness study and on other developments in VR and telemedicine at the American Association for Geriatric Psychiatry annual meeting.
Potential bridging tool
As the population ages, the prevalence of mental health disorders increases. Telemedicine has proved to be a potential “bridge” to address the health care needs of older adults, Dr. Sekhon noted.
She cited her systematic review of telemedicine for older adults with dementia during COVID-19. Results showed that telemedicine was a “beneficial approach” to assisting these individuals and that it increased accessibility, said Dr. Sekhon.
In addition, a survey published last year showed that 87% of Americans in general want to continue using telehealth services after the pandemic. Most respondents agreed that telehealth had made it easier to get the care they needed. They also reported having received the same level of care via telehealth as with in-person care.
A growing body of research shows that VR has “positive influences on mood and well-being, cognition, pain management, [and] treatment of phobias in younger adults,” Dr. Sekhon said. She added that there is evidence that VR is feasible for older adults, with applications in cognitive disorders.
She cited a recent systematic review of 55 studies that assessed the impact of different types of VR on mental health in older adults. The results showed that VR could be helpful in screening for cognitive impairment – and it was comparable to some paper-based assessment. It was also useful as a training tool for those with cognitive impairment.
Examples of VR interventions that can be used to treat cognitive impairment include “virtual cities, kitchens, supermarkets,” Dr. Sekhon noted.
The technology is increasingly being used as a tool to deliver psychotherapy, in which patient engagement is “a key determinant” of outcomes, she added. “Virtual reality is a cutting-edge, engaging, and immersive technique to administer psychotherapy,” she said.
Such VR approaches are proving successful in older patients. Dr. Sekhon highlighted the case of an 85-year-old woman who engaged in ten sessions of psychodynamic psychotherapy that targeted persistent dysthymia and negativistic mood. The case was part of a proof-of-concept study published in the May issue of the American Journal of Geriatric Psychiatry.
Dr. Sekhon noted the intervention was well tolerated and was associated with minimal side effects.
VR-based meditation
Dr. Sekhon and her colleagues are now conducting a randomized controlled trial of VR meditation in older adults. VR-based meditation has been shown to increase relaxation and to decrease anxiety, sadness, and anger in younger adults. However, it has not been studied in the geriatric population.
The pilot study is assessing the feasibility and tolerability of VR meditation for older adults and its effects on stress, anxiety, depression, sleep, and quality of life. The study involves 30 adults aged 60 years and older.
Participants receive either 15-minute VR mindfulness meditation sessions twice a week for 4 weeks or are on a control wait list. The meditation sessions are user friendly and focus on breath meditation and body scans, Dr. Sekhon reported.
Because participants are older and balance is a concern, safety steps are incorporated into the sessions. “We ensure they’re doing this in a seated position, in a chair with arm rests, so that they’re very stable and there’s no risk of falls,” said Dr. Sekhon.
Another concern with VR is motion sickness, she noted. “It’s pretty minimal, but the best way we found so far is giving older adults time to adapt and feel comfortable with the VR,” she said. From the first session, participants learn how to put on the device and are checked to make sure they are comfortable with the process. To help them get used to everything, video and audio are not included during the first session.
Dr. Sekhon noted that results from the study are expected later this year.
In addition to mindfulness, researchers are using VR to deliver other established interventions, such as exposure therapy – and are implementing these approaches in varied environments, including long-term and palliative care settings.
VR-related technology is constantly improving and is becoming easier to use and more affordable, said Dr. Sekhon. She noted that the simplest devices that rely on smartphones cost as little as $15.
Although VR in older adults is promising, there are barriers to its adoption and use in research, she noted. For example, older adults may have cognitive, visual, or hearing impairments. They may have limited digital literacy, and/or they may not have access to the required technology.
These barriers can be overcome through workarounds, including providing instructional videos and digital literacy assistance via Zoom and working with community partners to facilitate study recruitment of older patients, Dr. Sekhon said.
Dr. Sekhon’s research is funded by the Canadian Institutes of Health Research and the Fonds de recherche du Quebec Sante.
A version of this article first appeared on Medscape.com.
FROM AAGP 2022
‘Alarming, unexpected’ rate of suicidal behavior in long-term care residents
In a meta-analysis that included 20 studies and more than 3 million total individuals living in long-term care (LTC), the prevalence rate for suicidal behavior was more than 6%. In addition, the most common of these behaviors was suicidal ideation.
The prevalence was much higher in women than in men.
These high rates underline the need for clinicians to exercise “extra caution” when assessing elderly people living in a long-term care facility, coinvestigator Syeda Beenish Bareeqa, MBBS, clinical researcher, Jinnah Medical and Dental College, Karachi, Pakistan, and research observer, University of Texas Southwestern Medical Center, Dallas, said in an interview.
“Missed diagnoses or undertreatment in this population can lead to deleterious health outcomes,” Dr. Bareeqa said.
The findings were presented at the annual meeting of the American Association for Geriatric Psychiatry.
Underdiagnosed, undertreated
In the United States, about 42% of adults 70 years and older will live in LTC, either in an assisted care facility or a nursing home, Dr. Bareeqa noted.
Although many LTC residents have a mood disorder, previous research shows that fewer than 25% of cases are diagnosed and treated, she said.
Dr. Bareeqa added that suicide – and its association with factors such as the COVID-19 pandemic, depression, and cyberbullying – is a topic of increasing interest to researchers. She and her colleagues wanted to investigate suicidal behaviors in the setting of LTC.
The researchers conducted a literature search for studies of suicidal behavior among LTC residents over aged 60 years. They examined general suicidal behavior and the most common subtypes: suicide ideation, suicide attempts, completed suicide, self-destructive behavior, and nonsuicidal self-injury.
The analysis included 20 studies and 3 million individuals living in LTC. The majority of the studies were conducted in the United States (n = 5) and Australia (n = 4).
Results showed an estimated suicidal behavior prevalence rate of 6.4% (.064; 95% confidence interval, .057 to .070), or 64 per 100,000 persons.
A rate this high is “alarming and unexpected,” said Dr. Bareeqa. She noted most of the studies included in the analysis were conducted in developed countries with advanced health care systems.
The World Health Organization reports the suicide rate per 100,000 older adults (aged 75 years and older) is 50 for men and 16 for women, but this is not stratified by living settings, Dr. Bareeqa noted.
Higher rates in women
In the current analysis, 5 of the 20 studies had low risk of bias, 14 had moderate risk, and 1 had high risk, Dr. Bareeqa reported.
In subgroup analyses, the researchers found much of the suicidal behavior was driven by studies out of Australia, where the prevalence of suicidal behaviors was 36.9% (95% CI, 9.2-64.7) vs. 1.4% in the U.S. (95% CI, 1.0-1.8).
Another surprising finding was the prevalence of suicidal behaviors among women (15.8%), which was much higher than among men (7.9%). “Male gender is a well-established risk factor for suicide in the medical literature but this is not the case in our study,” said Dr. Bareeqa.
In addition, the analysis showed suicidal ideation was the most common type of suicidal behavior. In a pooled population of around 2 million people in eight studies, the prevalence of suicidal ideation was 12%.
For psychiatric illnesses accompanying suicidal behavior, the prevalence of depression alone was 14.4%, which was much higher than the rate of 5.1% for multiple comorbidities – including depression, anxiety, obsessive-compulsive disorder, psychotic disorder, history of previous suicide attempt, delusion, delirium, and hallucination.
Although depression and other psychiatric conditions may help explain suicidal behavior in older adults, Dr. Bareeqa said physical illness also plays a major role.
“Illnesses like cancer or end-stage organ failure, which are quite common with advancing age, are debilitating and in some instances incurable. These medical problems create a breeding ground for mental health problems and can eventually lead to devastating outcomes such as suicide,” she said.
She noted the importance of a “multipronged approach” to prevent suicide among older people in LTC facilities.
In addition, her research team aims to assess the quality of care provided by LTC facilities. “Maybe we can get to the root of this problem and devise strategies to improve it,” she said.
‘Not uncommon’
In an interview with this news organization Rajesh R. Tampi, MBBS, professor and chairman, department of psychiatry, Creighton University and Catholic Health Initiatives Health Behavioral Health Services, Omaha, Neb., said the results suggest that, despite the risk for bias among the included studies, “suicidal behaviors are not uncommon among older adults in LTC.”
The analysis describes only associations “but does not indicate causality,” said Dr. Tampi, past president of the AAGP. He was not involved with the research.
Additional subgroup analyses should yield information on possible risk factors for suicidal behaviors in LTC, such as depression, anxiety, and chronic pain, he added.
A version of this article first appeared on Medscape.com.
In a meta-analysis that included 20 studies and more than 3 million total individuals living in long-term care (LTC), the prevalence rate for suicidal behavior was more than 6%. In addition, the most common of these behaviors was suicidal ideation.
The prevalence was much higher in women than in men.
These high rates underline the need for clinicians to exercise “extra caution” when assessing elderly people living in a long-term care facility, coinvestigator Syeda Beenish Bareeqa, MBBS, clinical researcher, Jinnah Medical and Dental College, Karachi, Pakistan, and research observer, University of Texas Southwestern Medical Center, Dallas, said in an interview.
“Missed diagnoses or undertreatment in this population can lead to deleterious health outcomes,” Dr. Bareeqa said.
The findings were presented at the annual meeting of the American Association for Geriatric Psychiatry.
Underdiagnosed, undertreated
In the United States, about 42% of adults 70 years and older will live in LTC, either in an assisted care facility or a nursing home, Dr. Bareeqa noted.
Although many LTC residents have a mood disorder, previous research shows that fewer than 25% of cases are diagnosed and treated, she said.
Dr. Bareeqa added that suicide – and its association with factors such as the COVID-19 pandemic, depression, and cyberbullying – is a topic of increasing interest to researchers. She and her colleagues wanted to investigate suicidal behaviors in the setting of LTC.
The researchers conducted a literature search for studies of suicidal behavior among LTC residents over aged 60 years. They examined general suicidal behavior and the most common subtypes: suicide ideation, suicide attempts, completed suicide, self-destructive behavior, and nonsuicidal self-injury.
The analysis included 20 studies and 3 million individuals living in LTC. The majority of the studies were conducted in the United States (n = 5) and Australia (n = 4).
Results showed an estimated suicidal behavior prevalence rate of 6.4% (.064; 95% confidence interval, .057 to .070), or 64 per 100,000 persons.
A rate this high is “alarming and unexpected,” said Dr. Bareeqa. She noted most of the studies included in the analysis were conducted in developed countries with advanced health care systems.
The World Health Organization reports the suicide rate per 100,000 older adults (aged 75 years and older) is 50 for men and 16 for women, but this is not stratified by living settings, Dr. Bareeqa noted.
Higher rates in women
In the current analysis, 5 of the 20 studies had low risk of bias, 14 had moderate risk, and 1 had high risk, Dr. Bareeqa reported.
In subgroup analyses, the researchers found much of the suicidal behavior was driven by studies out of Australia, where the prevalence of suicidal behaviors was 36.9% (95% CI, 9.2-64.7) vs. 1.4% in the U.S. (95% CI, 1.0-1.8).
Another surprising finding was the prevalence of suicidal behaviors among women (15.8%), which was much higher than among men (7.9%). “Male gender is a well-established risk factor for suicide in the medical literature but this is not the case in our study,” said Dr. Bareeqa.
In addition, the analysis showed suicidal ideation was the most common type of suicidal behavior. In a pooled population of around 2 million people in eight studies, the prevalence of suicidal ideation was 12%.
For psychiatric illnesses accompanying suicidal behavior, the prevalence of depression alone was 14.4%, which was much higher than the rate of 5.1% for multiple comorbidities – including depression, anxiety, obsessive-compulsive disorder, psychotic disorder, history of previous suicide attempt, delusion, delirium, and hallucination.
Although depression and other psychiatric conditions may help explain suicidal behavior in older adults, Dr. Bareeqa said physical illness also plays a major role.
“Illnesses like cancer or end-stage organ failure, which are quite common with advancing age, are debilitating and in some instances incurable. These medical problems create a breeding ground for mental health problems and can eventually lead to devastating outcomes such as suicide,” she said.
She noted the importance of a “multipronged approach” to prevent suicide among older people in LTC facilities.
In addition, her research team aims to assess the quality of care provided by LTC facilities. “Maybe we can get to the root of this problem and devise strategies to improve it,” she said.
‘Not uncommon’
In an interview with this news organization Rajesh R. Tampi, MBBS, professor and chairman, department of psychiatry, Creighton University and Catholic Health Initiatives Health Behavioral Health Services, Omaha, Neb., said the results suggest that, despite the risk for bias among the included studies, “suicidal behaviors are not uncommon among older adults in LTC.”
The analysis describes only associations “but does not indicate causality,” said Dr. Tampi, past president of the AAGP. He was not involved with the research.
Additional subgroup analyses should yield information on possible risk factors for suicidal behaviors in LTC, such as depression, anxiety, and chronic pain, he added.
A version of this article first appeared on Medscape.com.
In a meta-analysis that included 20 studies and more than 3 million total individuals living in long-term care (LTC), the prevalence rate for suicidal behavior was more than 6%. In addition, the most common of these behaviors was suicidal ideation.
The prevalence was much higher in women than in men.
These high rates underline the need for clinicians to exercise “extra caution” when assessing elderly people living in a long-term care facility, coinvestigator Syeda Beenish Bareeqa, MBBS, clinical researcher, Jinnah Medical and Dental College, Karachi, Pakistan, and research observer, University of Texas Southwestern Medical Center, Dallas, said in an interview.
“Missed diagnoses or undertreatment in this population can lead to deleterious health outcomes,” Dr. Bareeqa said.
The findings were presented at the annual meeting of the American Association for Geriatric Psychiatry.
Underdiagnosed, undertreated
In the United States, about 42% of adults 70 years and older will live in LTC, either in an assisted care facility or a nursing home, Dr. Bareeqa noted.
Although many LTC residents have a mood disorder, previous research shows that fewer than 25% of cases are diagnosed and treated, she said.
Dr. Bareeqa added that suicide – and its association with factors such as the COVID-19 pandemic, depression, and cyberbullying – is a topic of increasing interest to researchers. She and her colleagues wanted to investigate suicidal behaviors in the setting of LTC.
The researchers conducted a literature search for studies of suicidal behavior among LTC residents over aged 60 years. They examined general suicidal behavior and the most common subtypes: suicide ideation, suicide attempts, completed suicide, self-destructive behavior, and nonsuicidal self-injury.
The analysis included 20 studies and 3 million individuals living in LTC. The majority of the studies were conducted in the United States (n = 5) and Australia (n = 4).
Results showed an estimated suicidal behavior prevalence rate of 6.4% (.064; 95% confidence interval, .057 to .070), or 64 per 100,000 persons.
A rate this high is “alarming and unexpected,” said Dr. Bareeqa. She noted most of the studies included in the analysis were conducted in developed countries with advanced health care systems.
The World Health Organization reports the suicide rate per 100,000 older adults (aged 75 years and older) is 50 for men and 16 for women, but this is not stratified by living settings, Dr. Bareeqa noted.
Higher rates in women
In the current analysis, 5 of the 20 studies had low risk of bias, 14 had moderate risk, and 1 had high risk, Dr. Bareeqa reported.
In subgroup analyses, the researchers found much of the suicidal behavior was driven by studies out of Australia, where the prevalence of suicidal behaviors was 36.9% (95% CI, 9.2-64.7) vs. 1.4% in the U.S. (95% CI, 1.0-1.8).
Another surprising finding was the prevalence of suicidal behaviors among women (15.8%), which was much higher than among men (7.9%). “Male gender is a well-established risk factor for suicide in the medical literature but this is not the case in our study,” said Dr. Bareeqa.
In addition, the analysis showed suicidal ideation was the most common type of suicidal behavior. In a pooled population of around 2 million people in eight studies, the prevalence of suicidal ideation was 12%.
For psychiatric illnesses accompanying suicidal behavior, the prevalence of depression alone was 14.4%, which was much higher than the rate of 5.1% for multiple comorbidities – including depression, anxiety, obsessive-compulsive disorder, psychotic disorder, history of previous suicide attempt, delusion, delirium, and hallucination.
Although depression and other psychiatric conditions may help explain suicidal behavior in older adults, Dr. Bareeqa said physical illness also plays a major role.
“Illnesses like cancer or end-stage organ failure, which are quite common with advancing age, are debilitating and in some instances incurable. These medical problems create a breeding ground for mental health problems and can eventually lead to devastating outcomes such as suicide,” she said.
She noted the importance of a “multipronged approach” to prevent suicide among older people in LTC facilities.
In addition, her research team aims to assess the quality of care provided by LTC facilities. “Maybe we can get to the root of this problem and devise strategies to improve it,” she said.
‘Not uncommon’
In an interview with this news organization Rajesh R. Tampi, MBBS, professor and chairman, department of psychiatry, Creighton University and Catholic Health Initiatives Health Behavioral Health Services, Omaha, Neb., said the results suggest that, despite the risk for bias among the included studies, “suicidal behaviors are not uncommon among older adults in LTC.”
The analysis describes only associations “but does not indicate causality,” said Dr. Tampi, past president of the AAGP. He was not involved with the research.
Additional subgroup analyses should yield information on possible risk factors for suicidal behaviors in LTC, such as depression, anxiety, and chronic pain, he added.
A version of this article first appeared on Medscape.com.
FROM AAGP 2022
Older adults with schizophrenia need ‘person-centered’ care
For example, individuals in a group characterized by substance use disorders (SUDs) had a depression prevalence of about 60% and relatively high death rates from unintentional injury and hepatitis.
“The health care needs of older adults with schizophrenia can vary widely, so aging persons with schizophrenia can’t be considered a uniform population,” study investigator Alison Hwong, MD, PhD, University of California, San Francisco, National Clinicians Scholars Program and San Francisco Veterans Affairs, told this news organization.
“For patients with multiple chronic conditions, we need to be proactive in coordinating specialty care. At the same time, we need novel models of person-centered care to help aging adults with schizophrenia live longer, healthier lives,” Dr. Hwong added.
The findings were presented as part of the American Association for Geriatric Psychiatry annual meeting.
Widening mortality gap
The life expectancy of patients with schizophrenia is lower by 8-15 years, compared with those without schizophrenia and this “mortality gap” has widened in recent years, Dr. Hwong noted. Those with schizophrenia also have high rates of health care utilization and high direct and indirect health care costs.
Most previous research looking at illness in schizophrenia focused on a single medical condition, “but by midlife, adults with schizophrenia may have multiple medical conditions,” said Dr. Hwong. “Little is known about multimorbidity in aging adults with schizophrenia and how that could be related to mortality outcomes.”
The study included 82,858 U.S. veterans aged 50 years and older who had at least one inpatient or two outpatient encounters associated with a diagnosis of schizophrenia in the previous 2 years. The study period ran from 2012 to 2018.
Using health care records and data linkages, researchers examined 20 common medical and psychiatric conditions other than schizophrenia that required medical attention. The investigators used the “latent class analysis” statistical model to assess differences across classes.
The study included three distinct patient classes: minimal morbidity (43% of the cohort), depression and medical comorbidity (34.2%), and SUDs and related conditions (22.8%).
The SUD group tended to be younger, with a mean age of 57.9 years versus 60.4 years for the minimal comorbidity group and 65.9 years for the depression group.
The SUD group was also less likely to be female (4.8% vs. 6.7% and 6%, respectively), less likely to be White, and more likely to be Black. This group was also less likely to be married and more likely to have a history of homelessness.
Disease prevalence rates
Results showed the minimal morbidity group had prevalence rates of less than 10% for all major conditions, except for tobacco dependence, which had a rate of 11.8%.
The depression and medical comorbidity group had very high prevalence rates (more than 20%) for heart attack, heart failure, stroke, cancer, dementia, arthritis, renal disease, sleep disorders, depression, and tobacco dependence. In addition, the rate was 60% for chronic obstructive pulmonary disease.
Participants in the SUD and related conditions group had rates of more than 70% for alcohol use disorder, other drug use disorders, and tobacco dependence. They also had high rates of COPD, hepatitis C, chronic pain, sleep disorders, depression, and PTSD.
On average, the SUD group was younger and may explain why they were less likely to have heart failure and renal disease, Dr. Hwong noted. These results may help inform treatment approaches, she added.
“For the group with largely substance use–related conditions, perhaps we can better address their needs with, for example, specific addiction and infectious disease services instead of a one-size-fits-all model,” said Dr. Hwong.
The investigators also examined mortality rates. Those in the depression and morbidity group had the highest rate of overall mortality; 47.5% of this class died during the observation period, compared with 27.2% of the SUD group.
More research is needed to understand why the mortality rate is so high in the depression and morbidity group, she said.
High rates of accidental death
The SUD group had the highest rates of death from accidents, possibly from overdoses, suicide, hepatitis C, and alcohol use–related deaths. “Their risks are very specific and appear largely related to substance use,” Dr. Hwong said.
The minimal comorbidity group showed the lowest rates of overall mortality rate (18%) and of cause-specific mortality for most of the included conditions.
Dr. Hwong noted she would like to study this class further. “I’m interested to know who are the people with schizophrenia who are thriving and are successfully aging – to learn what is going well for them.”
The researchers also plan to examine the subgroups in more detail to understand differences in treatments, health care utilization, and outcomes across groups. They are also interested in assessing other predictors of mortality outcomes in addition to multimorbidity.
One limitation of the study is that its cohort consisted of male veterans, so the findings may not be generalizable to other populations. In addition, these were observational data and so the results do not imply causality, Dr. Hwong said.
Dr. Hwong reported no relevant financial relationships, but she is supported by the VA and the UCSF National Clinician Scholars Program.
A version of this article first appeared on Medscape.com.
For example, individuals in a group characterized by substance use disorders (SUDs) had a depression prevalence of about 60% and relatively high death rates from unintentional injury and hepatitis.
“The health care needs of older adults with schizophrenia can vary widely, so aging persons with schizophrenia can’t be considered a uniform population,” study investigator Alison Hwong, MD, PhD, University of California, San Francisco, National Clinicians Scholars Program and San Francisco Veterans Affairs, told this news organization.
“For patients with multiple chronic conditions, we need to be proactive in coordinating specialty care. At the same time, we need novel models of person-centered care to help aging adults with schizophrenia live longer, healthier lives,” Dr. Hwong added.
The findings were presented as part of the American Association for Geriatric Psychiatry annual meeting.
Widening mortality gap
The life expectancy of patients with schizophrenia is lower by 8-15 years, compared with those without schizophrenia and this “mortality gap” has widened in recent years, Dr. Hwong noted. Those with schizophrenia also have high rates of health care utilization and high direct and indirect health care costs.
Most previous research looking at illness in schizophrenia focused on a single medical condition, “but by midlife, adults with schizophrenia may have multiple medical conditions,” said Dr. Hwong. “Little is known about multimorbidity in aging adults with schizophrenia and how that could be related to mortality outcomes.”
The study included 82,858 U.S. veterans aged 50 years and older who had at least one inpatient or two outpatient encounters associated with a diagnosis of schizophrenia in the previous 2 years. The study period ran from 2012 to 2018.
Using health care records and data linkages, researchers examined 20 common medical and psychiatric conditions other than schizophrenia that required medical attention. The investigators used the “latent class analysis” statistical model to assess differences across classes.
The study included three distinct patient classes: minimal morbidity (43% of the cohort), depression and medical comorbidity (34.2%), and SUDs and related conditions (22.8%).
The SUD group tended to be younger, with a mean age of 57.9 years versus 60.4 years for the minimal comorbidity group and 65.9 years for the depression group.
The SUD group was also less likely to be female (4.8% vs. 6.7% and 6%, respectively), less likely to be White, and more likely to be Black. This group was also less likely to be married and more likely to have a history of homelessness.
Disease prevalence rates
Results showed the minimal morbidity group had prevalence rates of less than 10% for all major conditions, except for tobacco dependence, which had a rate of 11.8%.
The depression and medical comorbidity group had very high prevalence rates (more than 20%) for heart attack, heart failure, stroke, cancer, dementia, arthritis, renal disease, sleep disorders, depression, and tobacco dependence. In addition, the rate was 60% for chronic obstructive pulmonary disease.
Participants in the SUD and related conditions group had rates of more than 70% for alcohol use disorder, other drug use disorders, and tobacco dependence. They also had high rates of COPD, hepatitis C, chronic pain, sleep disorders, depression, and PTSD.
On average, the SUD group was younger and may explain why they were less likely to have heart failure and renal disease, Dr. Hwong noted. These results may help inform treatment approaches, she added.
“For the group with largely substance use–related conditions, perhaps we can better address their needs with, for example, specific addiction and infectious disease services instead of a one-size-fits-all model,” said Dr. Hwong.
The investigators also examined mortality rates. Those in the depression and morbidity group had the highest rate of overall mortality; 47.5% of this class died during the observation period, compared with 27.2% of the SUD group.
More research is needed to understand why the mortality rate is so high in the depression and morbidity group, she said.
High rates of accidental death
The SUD group had the highest rates of death from accidents, possibly from overdoses, suicide, hepatitis C, and alcohol use–related deaths. “Their risks are very specific and appear largely related to substance use,” Dr. Hwong said.
The minimal comorbidity group showed the lowest rates of overall mortality rate (18%) and of cause-specific mortality for most of the included conditions.
Dr. Hwong noted she would like to study this class further. “I’m interested to know who are the people with schizophrenia who are thriving and are successfully aging – to learn what is going well for them.”
The researchers also plan to examine the subgroups in more detail to understand differences in treatments, health care utilization, and outcomes across groups. They are also interested in assessing other predictors of mortality outcomes in addition to multimorbidity.
One limitation of the study is that its cohort consisted of male veterans, so the findings may not be generalizable to other populations. In addition, these were observational data and so the results do not imply causality, Dr. Hwong said.
Dr. Hwong reported no relevant financial relationships, but she is supported by the VA and the UCSF National Clinician Scholars Program.
A version of this article first appeared on Medscape.com.
For example, individuals in a group characterized by substance use disorders (SUDs) had a depression prevalence of about 60% and relatively high death rates from unintentional injury and hepatitis.
“The health care needs of older adults with schizophrenia can vary widely, so aging persons with schizophrenia can’t be considered a uniform population,” study investigator Alison Hwong, MD, PhD, University of California, San Francisco, National Clinicians Scholars Program and San Francisco Veterans Affairs, told this news organization.
“For patients with multiple chronic conditions, we need to be proactive in coordinating specialty care. At the same time, we need novel models of person-centered care to help aging adults with schizophrenia live longer, healthier lives,” Dr. Hwong added.
The findings were presented as part of the American Association for Geriatric Psychiatry annual meeting.
Widening mortality gap
The life expectancy of patients with schizophrenia is lower by 8-15 years, compared with those without schizophrenia and this “mortality gap” has widened in recent years, Dr. Hwong noted. Those with schizophrenia also have high rates of health care utilization and high direct and indirect health care costs.
Most previous research looking at illness in schizophrenia focused on a single medical condition, “but by midlife, adults with schizophrenia may have multiple medical conditions,” said Dr. Hwong. “Little is known about multimorbidity in aging adults with schizophrenia and how that could be related to mortality outcomes.”
The study included 82,858 U.S. veterans aged 50 years and older who had at least one inpatient or two outpatient encounters associated with a diagnosis of schizophrenia in the previous 2 years. The study period ran from 2012 to 2018.
Using health care records and data linkages, researchers examined 20 common medical and psychiatric conditions other than schizophrenia that required medical attention. The investigators used the “latent class analysis” statistical model to assess differences across classes.
The study included three distinct patient classes: minimal morbidity (43% of the cohort), depression and medical comorbidity (34.2%), and SUDs and related conditions (22.8%).
The SUD group tended to be younger, with a mean age of 57.9 years versus 60.4 years for the minimal comorbidity group and 65.9 years for the depression group.
The SUD group was also less likely to be female (4.8% vs. 6.7% and 6%, respectively), less likely to be White, and more likely to be Black. This group was also less likely to be married and more likely to have a history of homelessness.
Disease prevalence rates
Results showed the minimal morbidity group had prevalence rates of less than 10% for all major conditions, except for tobacco dependence, which had a rate of 11.8%.
The depression and medical comorbidity group had very high prevalence rates (more than 20%) for heart attack, heart failure, stroke, cancer, dementia, arthritis, renal disease, sleep disorders, depression, and tobacco dependence. In addition, the rate was 60% for chronic obstructive pulmonary disease.
Participants in the SUD and related conditions group had rates of more than 70% for alcohol use disorder, other drug use disorders, and tobacco dependence. They also had high rates of COPD, hepatitis C, chronic pain, sleep disorders, depression, and PTSD.
On average, the SUD group was younger and may explain why they were less likely to have heart failure and renal disease, Dr. Hwong noted. These results may help inform treatment approaches, she added.
“For the group with largely substance use–related conditions, perhaps we can better address their needs with, for example, specific addiction and infectious disease services instead of a one-size-fits-all model,” said Dr. Hwong.
The investigators also examined mortality rates. Those in the depression and morbidity group had the highest rate of overall mortality; 47.5% of this class died during the observation period, compared with 27.2% of the SUD group.
More research is needed to understand why the mortality rate is so high in the depression and morbidity group, she said.
High rates of accidental death
The SUD group had the highest rates of death from accidents, possibly from overdoses, suicide, hepatitis C, and alcohol use–related deaths. “Their risks are very specific and appear largely related to substance use,” Dr. Hwong said.
The minimal comorbidity group showed the lowest rates of overall mortality rate (18%) and of cause-specific mortality for most of the included conditions.
Dr. Hwong noted she would like to study this class further. “I’m interested to know who are the people with schizophrenia who are thriving and are successfully aging – to learn what is going well for them.”
The researchers also plan to examine the subgroups in more detail to understand differences in treatments, health care utilization, and outcomes across groups. They are also interested in assessing other predictors of mortality outcomes in addition to multimorbidity.
One limitation of the study is that its cohort consisted of male veterans, so the findings may not be generalizable to other populations. In addition, these were observational data and so the results do not imply causality, Dr. Hwong said.
Dr. Hwong reported no relevant financial relationships, but she is supported by the VA and the UCSF National Clinician Scholars Program.
A version of this article first appeared on Medscape.com.
FROM AAGP 2022
Aducanumab and ARIA: Does the FDA’s prescribing label put patients at risk?
Specifically, the drug’s label calls for three MRI brain scans before, and during, the titration period. The problem is the trial data used for the drug’s approval by the U.S. Food and Drug Administration included five MRIs to screen for ARIA.
“We recommend proceeding as per the clinical trials,” said Meghan Riddle, MD, associate director, Memory and Aging program, Butler Hospital, and assistant professor of psychiatry and human behavior, Brown University, Providence, R.I.
Dr. Riddle shared her team’s clinical experience with aducanumab, as well as information on four ARIA cases from their clinic, during a presentation at the American Association for Geriatric Psychiatry (AAGP) 2022 Annual Meeting.
Significant safety risk?
As previously reported by this news organization, the FDA granted accelerated approval of aducanumab for AD last year.
ARIA is the most common risk associated with aducanumab and has two types: ARIA-E (with edema) and ARIA-H (with hemosiderin). These can co-occur, particularly in areas of high amyloid burden, Dr. Riddle noted during her presentation.
ARIA is often detected incidentally via MRI. Patients are usually asymptomatic, but when they do have symptoms, headache, dizziness, and vision changes are the most common complaints. However, these are generally mild, said Dr. Riddle.
Nevertheless, in some cases, there can be severe sequelae, including severe edema or bleeding and seizures, she added.
A major risk factor for ARIA is apolipoprotein 4 (APOE ε4) status. Carriers are twice as likely to develop ARIA as non-carriers.
“If you’re heterozygote for APOE ε4, you have about a 40% chance of developing ARIA, and if you’re homozygote, you have about a 66% chance of developing ARIA,” Dr. Riddle said.
Given the high rate of ARIA in APOE ε4 carriers, the team from Butler Hospital recommends APOE testing prior to treatment with aducanumab.
The risk for developing ARIA is highest within the year of dose titration, Dr. Riddle noted. The current FDA label recommends obtaining a recent brain MRI, within 1 year, and then scans before the 7th and 12th infusions. However, the protocol during the clinical trials of aducanumab included MRI at baseline and prior to the 5th, 7th, 9th, and 12th infusions.
Dr. Riddle’s group has opted to continue the research protocol with new patients. “There’s concern that the decreased MRI monitoring based on the current FDA label may pose a significant safety risk, particularly among those who we know are already at a higher risk of developing ARIA,” she said.
Dr. Riddle also shared how her team selects aducanumab candidates. They need to have mild cognitive impairment (MCI), a mini-mental state examination (MMSE) score of 24 to 30, and a recent MRI to review for eligibility and APOE testing.
The most common reason for treatment exclusion is advanced disease and comorbidity, such as stroke.
Once approved for treatment, patients receive monthly infusions titrated over 6 months – 1 mg/kg for 2 months, 3 mg/kg for 2 months, 6 mg/kg for 2 months, then 10 mg/kg.
Patients are monitored to ensure safety and tolerability and regular review of MRI findings. In addition, patients and their families receive ongoing education about the drug.
Dr. Riddle and her team permanently discontinue the aducanumab if patients develop microhemorrhage, more than one area of superficial siderosis, more than 10 microhemorrhages, more than two episodes of ARIA, or severe symptoms of ARIA.
Four cases
Of the 11 patients who were candidates for aducanumab treatment, four developed ARIA. All are APOE ε4 carriers, with two homozygotes and two heterozygotes. All had severe radiographic ARIA-E, with one developing ARIA-H.
“Importantly, they were all initially asymptomatic and the ARIA was just picked up on their regular surveillance MRI,” said Dr. Riddle. She added that the drug was discontinued in all four cases.
Three of the ARIA cases were detected prior to the 5th scan, which is “concerning,” said Dr. Riddle. “Based on the current FDA label of safety monitoring, they don’t recommend doing that MRI. So [clinicians] would have dosed through that ARIA, which could put someone at much greater risk of developing severe symptoms.”
In addition, 14 patients at the center are receiving treatment with aducanumab. However, at this point they have not yet received their first MRI screen.
Dr. Riddle noted that when patients are told they are not candidates for treatment, or when treatment is discontinued, they are upset. However, she added, there is also a substantial level of understanding.
“We have a very layered discussion that includes the simple fact that we still aren’t sure if this is going to provide any clinical benefit, that this decision [to approve the drug] was accelerated, and that data are still being gathered,” Dr. Riddle added.
Dr. Riddle noted that the risk of ARIA is highest during the dose titration period: “There’s a signal that once you get to the 10 mg/kg dose, that plateaus.”
None of the patients at her center have reached that 12-month treatment mark. “The current plan is to do the MRI at 12 months then to give serial MRIs but less frequently, and whether that’s at 6 months or annually is yet to be determined.”
“We’re kind of writing these protocols as information evolves,” Dr. Riddle said.
The Memory and Aging Program receives grants from NIH-ADNI, Alzheimer’s Association, Fain Family Foundation, Joukowsky Family Foundation, Winter Family, Rhode Island Foundation, Goodman Family Foundation, and Global Alzheimer Platform Foundation; and clinical trials include: Lilly, Biogen, Genentech, Avid, Roche, Eisai, and Novartis. Dr. Riddle has disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Specifically, the drug’s label calls for three MRI brain scans before, and during, the titration period. The problem is the trial data used for the drug’s approval by the U.S. Food and Drug Administration included five MRIs to screen for ARIA.
“We recommend proceeding as per the clinical trials,” said Meghan Riddle, MD, associate director, Memory and Aging program, Butler Hospital, and assistant professor of psychiatry and human behavior, Brown University, Providence, R.I.
Dr. Riddle shared her team’s clinical experience with aducanumab, as well as information on four ARIA cases from their clinic, during a presentation at the American Association for Geriatric Psychiatry (AAGP) 2022 Annual Meeting.
Significant safety risk?
As previously reported by this news organization, the FDA granted accelerated approval of aducanumab for AD last year.
ARIA is the most common risk associated with aducanumab and has two types: ARIA-E (with edema) and ARIA-H (with hemosiderin). These can co-occur, particularly in areas of high amyloid burden, Dr. Riddle noted during her presentation.
ARIA is often detected incidentally via MRI. Patients are usually asymptomatic, but when they do have symptoms, headache, dizziness, and vision changes are the most common complaints. However, these are generally mild, said Dr. Riddle.
Nevertheless, in some cases, there can be severe sequelae, including severe edema or bleeding and seizures, she added.
A major risk factor for ARIA is apolipoprotein 4 (APOE ε4) status. Carriers are twice as likely to develop ARIA as non-carriers.
“If you’re heterozygote for APOE ε4, you have about a 40% chance of developing ARIA, and if you’re homozygote, you have about a 66% chance of developing ARIA,” Dr. Riddle said.
Given the high rate of ARIA in APOE ε4 carriers, the team from Butler Hospital recommends APOE testing prior to treatment with aducanumab.
The risk for developing ARIA is highest within the year of dose titration, Dr. Riddle noted. The current FDA label recommends obtaining a recent brain MRI, within 1 year, and then scans before the 7th and 12th infusions. However, the protocol during the clinical trials of aducanumab included MRI at baseline and prior to the 5th, 7th, 9th, and 12th infusions.
Dr. Riddle’s group has opted to continue the research protocol with new patients. “There’s concern that the decreased MRI monitoring based on the current FDA label may pose a significant safety risk, particularly among those who we know are already at a higher risk of developing ARIA,” she said.
Dr. Riddle also shared how her team selects aducanumab candidates. They need to have mild cognitive impairment (MCI), a mini-mental state examination (MMSE) score of 24 to 30, and a recent MRI to review for eligibility and APOE testing.
The most common reason for treatment exclusion is advanced disease and comorbidity, such as stroke.
Once approved for treatment, patients receive monthly infusions titrated over 6 months – 1 mg/kg for 2 months, 3 mg/kg for 2 months, 6 mg/kg for 2 months, then 10 mg/kg.
Patients are monitored to ensure safety and tolerability and regular review of MRI findings. In addition, patients and their families receive ongoing education about the drug.
Dr. Riddle and her team permanently discontinue the aducanumab if patients develop microhemorrhage, more than one area of superficial siderosis, more than 10 microhemorrhages, more than two episodes of ARIA, or severe symptoms of ARIA.
Four cases
Of the 11 patients who were candidates for aducanumab treatment, four developed ARIA. All are APOE ε4 carriers, with two homozygotes and two heterozygotes. All had severe radiographic ARIA-E, with one developing ARIA-H.
“Importantly, they were all initially asymptomatic and the ARIA was just picked up on their regular surveillance MRI,” said Dr. Riddle. She added that the drug was discontinued in all four cases.
Three of the ARIA cases were detected prior to the 5th scan, which is “concerning,” said Dr. Riddle. “Based on the current FDA label of safety monitoring, they don’t recommend doing that MRI. So [clinicians] would have dosed through that ARIA, which could put someone at much greater risk of developing severe symptoms.”
In addition, 14 patients at the center are receiving treatment with aducanumab. However, at this point they have not yet received their first MRI screen.
Dr. Riddle noted that when patients are told they are not candidates for treatment, or when treatment is discontinued, they are upset. However, she added, there is also a substantial level of understanding.
“We have a very layered discussion that includes the simple fact that we still aren’t sure if this is going to provide any clinical benefit, that this decision [to approve the drug] was accelerated, and that data are still being gathered,” Dr. Riddle added.
Dr. Riddle noted that the risk of ARIA is highest during the dose titration period: “There’s a signal that once you get to the 10 mg/kg dose, that plateaus.”
None of the patients at her center have reached that 12-month treatment mark. “The current plan is to do the MRI at 12 months then to give serial MRIs but less frequently, and whether that’s at 6 months or annually is yet to be determined.”
“We’re kind of writing these protocols as information evolves,” Dr. Riddle said.
The Memory and Aging Program receives grants from NIH-ADNI, Alzheimer’s Association, Fain Family Foundation, Joukowsky Family Foundation, Winter Family, Rhode Island Foundation, Goodman Family Foundation, and Global Alzheimer Platform Foundation; and clinical trials include: Lilly, Biogen, Genentech, Avid, Roche, Eisai, and Novartis. Dr. Riddle has disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Specifically, the drug’s label calls for three MRI brain scans before, and during, the titration period. The problem is the trial data used for the drug’s approval by the U.S. Food and Drug Administration included five MRIs to screen for ARIA.
“We recommend proceeding as per the clinical trials,” said Meghan Riddle, MD, associate director, Memory and Aging program, Butler Hospital, and assistant professor of psychiatry and human behavior, Brown University, Providence, R.I.
Dr. Riddle shared her team’s clinical experience with aducanumab, as well as information on four ARIA cases from their clinic, during a presentation at the American Association for Geriatric Psychiatry (AAGP) 2022 Annual Meeting.
Significant safety risk?
As previously reported by this news organization, the FDA granted accelerated approval of aducanumab for AD last year.
ARIA is the most common risk associated with aducanumab and has two types: ARIA-E (with edema) and ARIA-H (with hemosiderin). These can co-occur, particularly in areas of high amyloid burden, Dr. Riddle noted during her presentation.
ARIA is often detected incidentally via MRI. Patients are usually asymptomatic, but when they do have symptoms, headache, dizziness, and vision changes are the most common complaints. However, these are generally mild, said Dr. Riddle.
Nevertheless, in some cases, there can be severe sequelae, including severe edema or bleeding and seizures, she added.
A major risk factor for ARIA is apolipoprotein 4 (APOE ε4) status. Carriers are twice as likely to develop ARIA as non-carriers.
“If you’re heterozygote for APOE ε4, you have about a 40% chance of developing ARIA, and if you’re homozygote, you have about a 66% chance of developing ARIA,” Dr. Riddle said.
Given the high rate of ARIA in APOE ε4 carriers, the team from Butler Hospital recommends APOE testing prior to treatment with aducanumab.
The risk for developing ARIA is highest within the year of dose titration, Dr. Riddle noted. The current FDA label recommends obtaining a recent brain MRI, within 1 year, and then scans before the 7th and 12th infusions. However, the protocol during the clinical trials of aducanumab included MRI at baseline and prior to the 5th, 7th, 9th, and 12th infusions.
Dr. Riddle’s group has opted to continue the research protocol with new patients. “There’s concern that the decreased MRI monitoring based on the current FDA label may pose a significant safety risk, particularly among those who we know are already at a higher risk of developing ARIA,” she said.
Dr. Riddle also shared how her team selects aducanumab candidates. They need to have mild cognitive impairment (MCI), a mini-mental state examination (MMSE) score of 24 to 30, and a recent MRI to review for eligibility and APOE testing.
The most common reason for treatment exclusion is advanced disease and comorbidity, such as stroke.
Once approved for treatment, patients receive monthly infusions titrated over 6 months – 1 mg/kg for 2 months, 3 mg/kg for 2 months, 6 mg/kg for 2 months, then 10 mg/kg.
Patients are monitored to ensure safety and tolerability and regular review of MRI findings. In addition, patients and their families receive ongoing education about the drug.
Dr. Riddle and her team permanently discontinue the aducanumab if patients develop microhemorrhage, more than one area of superficial siderosis, more than 10 microhemorrhages, more than two episodes of ARIA, or severe symptoms of ARIA.
Four cases
Of the 11 patients who were candidates for aducanumab treatment, four developed ARIA. All are APOE ε4 carriers, with two homozygotes and two heterozygotes. All had severe radiographic ARIA-E, with one developing ARIA-H.
“Importantly, they were all initially asymptomatic and the ARIA was just picked up on their regular surveillance MRI,” said Dr. Riddle. She added that the drug was discontinued in all four cases.
Three of the ARIA cases were detected prior to the 5th scan, which is “concerning,” said Dr. Riddle. “Based on the current FDA label of safety monitoring, they don’t recommend doing that MRI. So [clinicians] would have dosed through that ARIA, which could put someone at much greater risk of developing severe symptoms.”
In addition, 14 patients at the center are receiving treatment with aducanumab. However, at this point they have not yet received their first MRI screen.
Dr. Riddle noted that when patients are told they are not candidates for treatment, or when treatment is discontinued, they are upset. However, she added, there is also a substantial level of understanding.
“We have a very layered discussion that includes the simple fact that we still aren’t sure if this is going to provide any clinical benefit, that this decision [to approve the drug] was accelerated, and that data are still being gathered,” Dr. Riddle added.
Dr. Riddle noted that the risk of ARIA is highest during the dose titration period: “There’s a signal that once you get to the 10 mg/kg dose, that plateaus.”
None of the patients at her center have reached that 12-month treatment mark. “The current plan is to do the MRI at 12 months then to give serial MRIs but less frequently, and whether that’s at 6 months or annually is yet to be determined.”
“We’re kind of writing these protocols as information evolves,” Dr. Riddle said.
The Memory and Aging Program receives grants from NIH-ADNI, Alzheimer’s Association, Fain Family Foundation, Joukowsky Family Foundation, Winter Family, Rhode Island Foundation, Goodman Family Foundation, and Global Alzheimer Platform Foundation; and clinical trials include: Lilly, Biogen, Genentech, Avid, Roche, Eisai, and Novartis. Dr. Riddle has disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM AAGP 2022