It is a 5-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 5-year award which is expected to total $11.8 million from the National Institute on Aging (NIA) under award number R01AG06110001. Researchers at McLean Hospital, a Harvard Medical School Affiliate, will lead the study. Pine Rest will receive a $1.3 million sub-award for the study from McLean. The NIA, part of the National Institutes of Health, leads scientific efforts to study aging and Alzheimer’s disease.
The principal investigator is Brent P. Forester, M.D., M.Sc, and heads McLean’s Division of Geriatric Psychiatry and Geriatric Psychiatry Research Program. McLean Hospital researchers will collaborate with investigators at Pine Rest Christian Mental Health Services, Emory University, Mayo Clinic, and Northwell Health. The Medical University of South Carolina will serve as the study’s data coordinating site.
The study will be the first randomized, double-blind, controlled study of ECT for agitation and aggression in Alzheimer’s dementia. It 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.
“It is wonderful to have this grant from the National Institute on Aging. We have been interested in the use of ECT for the treatment of advanced dementia for many years and have been offering this treatment to patients and families for a long time,” says Eric Achtyes, M.D., M.S., D.F.A.P.A., staff psychiatrist, Pine Rest Christian Mental Health Services, and Michigan State University – College of Human Medicine, associate professor and chair, department of psychiatry west. “Several years ago, we conducted a pilot study of ECT in this patient population which showed promising results for reducing agitation associated with dementia. Now, thanks to this grant, we will be able to conduct a definitive study to assess the benefits and risks of using ECT for these individuals and the families who care for them.”
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 units 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 spring 2019.
Louis Nykamp, M.D., Pine Rest’s geriatric fellowship director and electroconvulsive therapy and transcranial magnetic stimulation clinic director will be serving as the Pine Rest principal investigator for this study. Dr. Nykamp is a geriatric trained psychiatrist with expertise in the assessment and treatment of dementias, as well as the use of ECT and other neuromodulation techniques such as transcranial magnetic stimulation. He was involved in drafting the grant and will lead the team here at Pine Rest in the safe conduct of this critically important and impactful study.
“Agitation and even aggression are unfortunately common in the context of the brain changes which occur in the late stages of Alzheimer’s dementia,” says Dr. Nykamp. “Many people can think of a family member or friend to whom this has occurred. There are currently no approved treatments and the medications typically used for these complications of the illness can come with troublesome side effects and often they don’t work as well as we’d hope.
“Pilot studies of ECT for these symptoms have been promising, and it has been a part of our clinical practice at Pine Rest to offer this when symptoms have been severe and refractory. We are very fortunate to have this grant opportunity to collaborate with excellent partners to study the effectiveness of ECT for severe agitation in dementia.”
Preliminary work to prepare Pine Rest’s ECT Clinic to participate in the NIA grant was funded by a $20,000 grant from the Pine Rest Foundation. With this funding the capacity to accurately and consistently track data and measure outcomes using standardized assessment tools was improved. This process gave staff experience with administering the standardized diagnostic, efficacy and side effect scales that are used in research and incorporated these measures into the clinic work flow preparing our team to participate in transformational research projects such as this.
When the study begins this spring, the teams from the five hospitals 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.