Early-stage Alzheimer disease: getting trial-ready

Area of Science:

• Neurology
• Clinical Trials
• Alzheimer's Disease Research

Background:

• Alzheimer disease (AD) represents a significant unmet medical need, with current therapies offering limited efficacy.
• Effective disease modification for AD necessitates early intervention during preclinical or prodromal stages.
• Recruiting asymptomatic or minimally symptomatic participants for early-stage AD clinical trials is time-consuming and costly.

Purpose of the Study:

• To review lessons learned from established Alzheimer disease trial-ready cohorts.
• To inform ongoing and future efforts for efficient and cost-effective clinical trial recruitment in AD.
• To highlight the need for innovative clinical trial infrastructure to accelerate therapeutic progress.

Main Methods:

• Review of established trial-ready cohorts in North America, Europe, and Asia focused on preclinical and prodromal AD.
• Analysis of innovative methods for engaging target populations and assessing amyloid accumulation risk.
• Examination of participant selection strategies for biomarker studies and trial eligibility.

Main Results:

• Established trial-ready cohorts are crucial for efficient recruitment of individuals with early-stage AD.
• Innovative engagement and assessment methods improve participant identification and selection.
• These programs demonstrate potential for advancing primary prevention strategies for AD.

Conclusions:

• A new clinical trials infrastructure is required to enhance recruitment efficiency and speed up therapeutic development for AD.
• Collaborative efforts in establishing trial-ready cohorts are vital for future AD research.
• Lessons learned from current cohorts will guide the development of more effective and accessible AD therapies.