The Pre-Screening Registry Open to All

Overview

A self-funded, IRB-approved pre-screening program offers participants a risk profile (biomarkers, cognitive testing, and FDA-approved amyloid disclosure) at no cost to them, plus a small incentive (~$25). Currently ~400 participants; the registry is filling roughly half of first-in-human cohorts and accelerating disease modification trials 2–3x. Upfront cost reduces screen failures and randomizes patients faster. A potential model for site-funded pre-screening programs.

Methods

Operate the LifeKey registry as a standing, IRB-approved biorepository and pre-screening protocol that any interested adult can join, regardless of cognitive status
No exclusion criteria and broad inclusion (age 18+) keep the funnel wide; participants self-select in rather than being screened out
Across up to three visits, collect personal and health history, memory testing, vital signs, and biospecimens — blood, urine, buccal/saliva, tissue, and optional CSF via lumbar puncture — building toward a target of 1,500 enrolled participants
Disclose APOE genotype and biomarker results to each participant (trained staff, opt-out available) at a dedicated disclosure visit, conducted in clinic or by phone
Cover testing and disclosure costs so the program is free to participants, plus a modest ~$25 incentive for their time
Store de-identified samples and data in a secure, access-controlled biorepository, making the registry immediately searchable against inclusion/exclusion criteria for new and upcoming studies

Metrics

~400 participants enrolled to date, with an ultimate target of 1,500-participants
Registry pre-fills roughly half of first-in-human cohort slots for new studies before recruitment even opens
Disease-modification trial enrollment accelerated 2–3x versus starting recruitment from zero
$0 cost to participants for a full biomarker, cognitive, and amyloid risk workup

Key Lessons

Funding the pre-screen upfront is cheaper than paying for it downstream — a warm, pre-characterized registry reduces screen failures and randomizes patients faster once a trial opens
Offering participants something of real value in return — their own APOE/biomarker results — is a strong draw even though the study itself carries no direct treatment benefit
Wide inclusion criteria (interest alone qualifies) grow the registry faster than diagnosis-gated recruitment
A standing, IRB-approved biorepository turns recruitment from a per-study sprint into a reusable asset that compounds with every new trial