The Patient in Your Alzheimer’s Disease Study May be in Another: Duplication and Deception in Clinical Trials of Alzheimer’s Disease

• Published in: The journal of prevention of Alzheimer's disease Vol. 7; no. 1; pp. 43 - 46
• Main Authors: Shiovitz, Thomas, Steinmiller, B., Steinmetz, C., Perez, S., Oseas, R.
• Format: Journal Article
• Language: English
• Published: Cham Springer International Publishing 2020
• Subjects: Aged; Alzheimer Disease - drug therapy; Brief Reports; Clinical Trials as Topic; Deception; Female; Geriatrics/Gerontology; Humans; Male; Medicine; Medicine & Public Health; Middle Aged; Neurology; Patient Selection; Registries; Research Design; duplicate subjects; Professional research subject; dual enrollment; deception
• ISSN: 2426-0266
• DOI: 10.14283/jpad.2020.3

Duplicate and deceptive subjects, a significant issue in CNS studies, are not often considered in Alzheimer’s Disease (AD) clinical trials. However, AD patients and their study partners may be motivated to take advantage of different mechanisms of action, increase odds of receiving active treatment, and/or obtain financial compensation, which may lead them to participate in multiple studies. CTSdatabase reviewed memory loss subjects (n=1087) from January 2017 through May 2019 to determine how many attempted to screen at multiple sites. 117 subjects (10.8%) visited more than one site within two years. When these potential AD subjects went to additional sites, it was predominantly for non-memory indications (often MDD or schizophrenia). For those that participated in studies, the rate of duplication approached 4% of screened AD subjects. This data indicates that significant numbers of AD subjects attempt to enroll at multiple sites, which confounds efficacy and safety signals in clinical trials.