[Current Clinical Trials in the Treatment of Alzheimer's Disease]

Area of Science:

• Neurology
• Pharmacology
• Biomedical Research

Background:

• Alzheimer's disease (AD) presents a growing global health challenge with limited effective therapeutic options.
• Numerous drug development trials for AD have faced failure, highlighting the need for improved strategies.

Purpose of the Study:

• To review current Alzheimer's disease (AD) clinical trial landscapes.
• To identify key challenges and propose innovative solutions for developing effective AD treatments.

Main Methods:

• Analysis of current AD clinical trial categories: disease-modifying therapies and symptomatic treatments.
• Examination of disease-modifying approaches, including anti-amyloid and anti-tau agents (small molecules, monoclonal antibodies, biological therapies).
• Review of common targets in Phase 2 and 3 trials, with amyloid being the most frequent.

Main Results:

• Amyloid remains the primary target in Phase 2 and 3 disease modification trials.
• Recent trials are increasingly enrolling earlier disease stages (preclinical, prodromal).
• Biomarker utilization is growing but not yet standardized for AD diagnosis confirmation.

Conclusions:

• Effective Alzheimer's disease (AD) drug development necessitates enrolling earlier disease populations.
• Integration of novel biomarkers (e.g., neurofilament light) and outcome measures (e.g., AD Composite Score [ADCOMS]) is crucial.
• Innovative trial designs, such as futility analyses and Bayesian adaptive designs, are essential for advancing AD therapeutics.