T2 Protect AD: Achieving a rapid recruitment timeline in a multisite clinical trial for individuals with mild to moderate Alzheimer's disease

Abstract

Abstract Introduction The 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. Methods T2 Protect AD (T2), a phase 2 randomized placebo‐controlled trial of troriluzole in mild to moderate AD, used multiple recruitment strategies. Results T2 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%). Discussion The rapid recruitment of participants with mild to moderate AD was achieved through a range of approaches with varying success.

Keywords

• Alzheimer's disease
• clinical trial
• drug development
• pharmacologic
• recruitment