The latest edition of the annual Alzheimer's disease (AD) drug development pipeline report, led by Dr. Jeffrey Cummings, a renowned Alzheimer's clinician-scientist, has been published in Alzheimer's & Dementia: Translational Research & Clinical Interventions. This comprehensive review provides an in-depth analysis of the current state of AD clinical trials and the drugs under investigation. The paper describes the AD drug development pipeline and provides a comprehensive overview of agents in Phase 1, 2, and 3 clinical trials, reporting the trial characteristics, clinical outcome measures and biomarkers. As of 1 January 2025, there were 182 active clinical trials assessing 138 drugs in the AD pipeline. This included 48 trials assessing 31 drugs in Phase 3; 86 trials assessing 75 drugs in Phase 2; and 48 trials assessing 45 drugs in Phase 1. Of the 182 trials, 16 were long-term extensions of agents in prior trials.
The AD drug development pipeline is comprised primarily of biological disease-targeted therapies (DTTs). Biomarkers play an important role in current trials to determine trial eligibility and as outcomes of trials. Repurposing is a developmental pathway that plays an important role in the 2025 AD pipeline. Repurposed agents represent a third of the pipeline agents. Additionally, all stages of the AD continuum are represented in current clinical trials. The 2025 pipeline has more trials and more drugs compared to the 2024 pipeline, which had 164 trials and 127 drugs. There has been a marked increase in Phase 1 activity with nearly twice as many trials (48 vs. 26) and drugs (45 vs. 25) in 2025 compared to 2024.