1. T2 Protect AD: Achieving a rapid recruitment timeline in a multisite clinical trial for individuals with mild to moderate Alzheimer's disease
- Author
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Shadyab, Aladdin H, LaCroix, Andrea Z, Matthews, Genevieve, Bennett, Daniel, Shadyab, Alexandre A, Tan, Donna, Thomas, Ronald G, Mason, Jennifer, Lopez, Alex, Askew, Brianna, Donahue, Lia, Kaplita, Stephen, Qureshi, Irfan A, Huisa, Branko, Feldman, Howard H, and Alzheimer's Disease Cooperative Study T2 Protect AD Study Group
- Subjects
Aging ,Clinical Trials and Supportive Activities ,Alzheimer's Disease including Alzheimer's Disease Related Dementias (AD/ADRD) ,clinical trial ,pharmacologic ,Alzheimer's disease ,Neurodegenerative ,drug development ,Brain Disorders ,recruitment ,Clinical Research ,Alzheimer's Disease Cooperative Study T2 Protect AD Study Group ,Acquired Cognitive Impairment ,Dementia - Abstract
IntroductionThe reporting of approaches facilitating the most efficient and timely recruitment of Alzheimer's disease (AD) patients into pharmacologic trials is fundamental to much-needed therapeutic progress.MethodsT2 Protect AD (T2), a phase 2 randomized placebo-controlled trial of troriluzole in mild to moderate AD, used multiple recruitment strategies.ResultsT2 exceeded its recruitment target, enrolling 350 participants between July 2018 and December 2019 (randomization rate: 0.87 randomizations/site/month, or 3-fold greater than recent trials of mild to moderate AD). The vast majority (98%) of participants were enrolled during a 10-month window of intense promotion in news media, TV and radio advertisements, and social media. The distribution of primary recruitment sources included: existing patient lists at participating sites (72.3%), news media (12.3%), physician referral (6.0%), word of mouth (3.1%), and paid advertising (2.9%).DiscussionThe rapid recruitment of participants with mild to moderate AD was achieved through a range of approaches with varying success.
- Published
- 2022