Perceived Impact on Alzheimer's Disease Clinical Trial Participants After Study Termination

• Published in: The American journal of geriatric psychiatry 2022-04, Vol.30 (4), p.S54-S55
• Main Authors: Santangelo, Isabella, Morehouse, Savannah, Drury, Mia, Harper, David, Forester, Brent
• Format: Article
• Language: English
• ISSN: 1064-7481; 1545-7214
• DOI: 10.1016/j.jagp.2022.01.046

Many pharmaceutical companies are working to identify novel treatments to slow or stop the progression of Alzheimer's Disease (AD), which they test through use of multi-site clinical trials. The Geriatric Psychiatry Research Program at McLean Hospital has been a study site in 8 clinical trials over the past 10 years, enrolling over 30 participants and their caregivers, or study partners. During the monthly, multi-hour study visits, McLean study staff accompanied participants and study partners and thus became familiar with the patient's clinical care. Two of the disease-modifying clinical trials conducted at McLean between 2012 and 2019 were terminated by the sponsors after interim analyses revealed study endpoints were not being met. Participants at McLean were immediately discontinued and required to stop infusions of study drug (or placebo) in both placebo-controlled and long-term extension phases of the trials. This abrupt discontinuation broke the pattern of regular study visits and consistent care the participants and study partners had come to expect, especially for those who had been involved in the same study for over 6 years. This observational, qualitative study seeks to examine the effects of study termination on participants and study partners and to provide insight into potential benefits of regular interaction with a consistent research care team. The primary goals of this study are to identify and characterize the impact that sponsor-initiated Alzheimer's clinical trial termination had on participants and their caregivers at McLean Hospital. Study aims were accomplished by collecting mood, memory, function, and study satisfaction surveys from participants or study partners who were enrolled in Eli Lilly's LZAO, Eli Lilly's LZAX, or Biogen's Emerge trials at McLean when discontinued. For this one-time study visit, 7 subject and 8 caregiver surveys were administered to eligible individuals. Participants were asked to reflect on their experiences and mood at the time of study termination, 4-weeks after termination, and at the time of this visit. We evaluated qualitative trends in reported changes in mood, memory, function, social support and overall study experience for former subjects and caregivers. There were 17 participants enrolled in the study - 12 caregivers and 5 subjects. Caregivers reported that the aspects of trial participation they valued most were social interactions with staff, sense of giving back by contributing to AD research