Document Type
Article
Publication Date
2-17-2026
Abstract
Biomarkers play an important role in Alzheimer's disease (AD) clinical trials in several contexts of use, including defining trial eligibility and serving as outcome measures. Utilizing clinicaltrials.gov, a registry of clinical trials, we assessed biomarker usage across all active AD disease-targeted therapeutic (DTT) trials. Biomarkers are widely used in AD DTT trials, with 84% including a fluid, imaging, and/or digital biomarker, either as an inclusion criterion or as an outcome measure. In DTT trials, biomarkers were included in 83% of Phase 3 trials, 91% of Phase 2 trials, and 72% of Phase 1 trials. Biomarkers were used for trial inclusion in 58% of DTT trials and as a primary outcome measure in 36%. Characterization of biomarker usage in AD clinical trials offer valuable insights across the drug development spectrum, with the goal of increasing trial efficiency and interpretation, while reducing time for new therapies to become available.
Recommended Citation
Osse AML, Zhou Y, Kinney JW, et al. Biomarkers in Alzheimer's disease clinical trials: 2025. Alzheimer's Dement. 2026; 12:e70217. https://doi.org/10.1002/trc2.70217
Supporting Information
trc270217-sup-0002-suppmat.pdf (1556 kB)
Supporting Information
Peer Reviewed
1
Copyright
The authors
Creative Commons License
This work is licensed under a Creative Commons Attribution-Noncommercial-No Derivative Works 4.0 License.
Included in
Nervous System Diseases Commons, Other Rehabilitation and Therapy Commons, Therapeutics Commons
Comments
This article was originally published in Alzheimer's & Dementia, volume 12, issue 1, in 2026. https://doi.org/10.1002/trc2.70217