Researchers at McLean Hospital will lead a five-year study to investigate the use of electroconvulsive therapy (ECT) to treat severe agitation and aggression in people with Alzheimer's disease. The study was made possible by a five-year grant, expected to total $11.8 million, from the National Institute on Aging (NIA) under award number R01AG06110001. Part of the National Institutes of Health, the NIA leads scientific efforts to study aging and Alzheimer's disease.
According to Brent P. Forester, MD, MSc, who is the principal investigator for this study and heads McLean's Division of Geriatric Psychiatry and Geriatric Psychiatry Research Program, "the study will be the first randomized, double-blind, controlled study of ECT for agitation and aggression in Alzheimer's dementia." The study will compare how ECT treatment plus standard treatments, such as antipsychotic medications and behavioral therapies, compares with standard therapies alone for individuals with Alzheimer's dementia with severe aggression and anxiety. McLean Hospital researchers will collaborate with investigators at Emory University, Mayo Clinic, Pine Rest Christian Mental Health Services, and Northwell Health. The Medical University of South Carolina will serve as the study's data coordinating site. Georgios Petrides, MD, who heads the division of ECT at the Zucker Hillside Hospital of Northwell Health in New York will serve as the co-principal investigator for this study.
For the study, 200 patients will be enrolled across the five sites. The study will be open to older adults or individuals who have been admitted to the inpatient geriatric psychiatry programs of any of the five participating sites and who have moderate-to-severe Alzheimer's disease, are experiencing agitation and aggression, and who have not been responsive to other forms of treatment. Enrollment is expected to begin in the spring of 2019.
The study is important, Forester said, because "almost everyone with Alzheimer's disease at some point over the course of their illness will have anxiety or depression or agitation." He explained that these behavioral symptoms "can lead to increased morbidity and mortality among individuals with Alzheimer's dementia." Moreover, per Forester, behavioral disturbances are "often the reason why people end up in long-term care facilities, why family members become burned out and exhausted emotionally and physically, and why primary caregivers die sooner than they otherwise would."
Despite the serious public health burden, Forester said that "there are currently no FDA-approved treatments for agitation and aggression in Alzheimer's disease." Medications currently utilized are often ineffective, he said, or they produce significant side effects. ECT, however, is "a well-established treatment for depression," he stated, and "early uncontrolled studies suggest that ECT may reduce the severity of agitation and aggression in individuals with Alzheimer's dementia who are not responding to current treatments."
Once the study begins, the team will interact regularly with a data safety monitoring board composed of experts in geriatric psychiatry, biostatistics, and ECT who will review every piece of data as well as the overall conduct of the study to provide an independent objective review of safety. The researchers will also provide a yearly progress report to the NIA.
Forester is excited to get started. "ECT is a well-established and safe treatment for people with severe depression or those who aren't responding to other treatments, especially in older adults," he said. "We know that ECT has also been successful in helping individuals with dementia and aggression. This study could be a pathway to helping improve the quality of life for people with Alzheimer's dementia complicated by severe aggression and agitation and their caregivers."
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