EU/US/CTAD Task Force: Lessons Learned from Recent and Current Alzheimer's Prevention Trials.

Area of Science:

• Neurology
• Clinical Trials
• Alzheimer's Disease Research

Background:

• The EU/US/Clinical Trials in Alzheimer's Disease (CTAD) Task Force convened to address challenges in Alzheimer's disease (AD) clinical trials.
• Focus on prevention trials and the pre-clinical stage of AD treatment development.

Framework:

• Reviewed lessons learned from ongoing and planned AD prevention trials.
• Identified critical areas for improvement across all trial aspects.

Implementation:

• Called for innovation in patient recruitment and retention strategies.
• Emphasized the need for robust infrastructure development for clinical trials.
• Discussed the selection of optimal outcome measures for assessing disease progression.

Implications:

• Cognitive changes are key markers, but optimal assessment tools for clinically meaningful endpoints are needed.
• Patient- and informant-reported outcomes present unique challenges but may offer valuable insights.
• Imaging and other biomarkers are essential for maximizing trial efficiency and data acquisition.