Introduction
Alzheimer’s disease, AD, dementia, HT
RECRUITMENT
Alzheimer’s disease (AD) is the most common cause of dementia, accounting for 50-75% of all cases (The Alzheimer’s Prevention Initiative (API) Generation Program was a collaboration among the Banner Alzheimer’s Institute, Novartis, and Amgen, and supported partially by funding from several philanthropic organizations and a grant from the National Institute on Aging of the National Institutes of Health (NIH). The API Generation Program consisted of two trials, Generation Studies 1 and 2, both with the objective of delaying the onset of clinical symptoms of AD in participants at increased risk for dementia due to AD. Generation Study 1 enrolled cognitively unimpaired APOE ε4 homozygotes (HMs) ages 60-75; Generation Study 2 enrolled cognitively unimpaired APOE ε4 carriers (HMs and heterozygotes (HTs) ages 60-75, HTs were required to have elevated brain amyloid)(The API Generation Program required a large outreach, recruitment, and screening funnel to enroll cognitively unimpaired adults ages 60-75 who were APOE ε4 HM or HT (and if HT, also had elevated brain amyloid). Based on data from other observational studies, we expected that about 2-3% of those entering screening would be APOE ε4 HMs and 24-25% to be APOE ε4 HTs, of whom about half would have elevated brain amyloid (Here we describe the tactics and strategies and their success in the outreach, recruitment, screening, and enrollment of participants into the API Generation Program, with a specific focus on identifying and enrolling cognitively unimpaired APOE ε4 HMs given the 2-3% prevalence of this genotype in the population (