Landmark Biomarker Observatory Paper Offers First Comprehensive View of Biomarker Use Across Alzheimer’s Clinical Trials

NEW YORK, NY – [February 24, 2026] – The Alzheimer’s Drug Discovery Foundation (ADDF) announces the recent publication of a first-of-its-kind report, “Biomarkers in Alzheimer’s Disease Clinical Trials: 2025,” in Alzheimer’s & Dementia: Translational Research & Clinical Interventions. Co-authored by renowned clinical trials expert and Goodes Prize recipient Jeffrey Cummings, MD, ScD; as well as the ADDF’s Howard Fillit, MD; Laura Nisenbaum, PhD; and Aaron Burstein, PharmD; among others, the paper provides the first comprehensive analysis of how biomarkers are being used across Alzheimer’s clinical trials, identifying gaps and providing critical guidance to help accelerate progress toward a precision medicine approach to Alzheimer’s treatment.

“This publication gives the field a powerful roadmap for strengthening the biomarker ecosystem, which underpins modern drug development,” said Dr. Nisenbaum, Executive Director of Drug Development at the ADDF. “Better biomarkers are essential to supporting the increasingly diverse therapeutic pipeline – where more than 70% of drugs in development now target novel pathways – and enabling our ultimate goal of treating Alzheimer’s using combination therapies and precision medicine, the same approach that has proven successful in cancer care.”

The report was developed through the Biomarker Observatory, an initiative supported by the ADDF to map and analyze the rapidly expanding Alzheimer’s biomarker landscape. The Observatory builds on the ADDF’s longstanding partnership with Dr. Cummings and complements his gold-standard annual clinical trials report. Together, these efforts reflect the ADDF’s sustained leadership, ensuring that as therapeutic strategies become more complex, the biomarkers needed to support them evolve in parallel.

“For the first time, this work brings together a comprehensive view of biomarker use across Alzheimer’s clinical trials,” said Dr. Cummings, Joy Chambers-Grundy Professor of Brain Science at the University of Nevada, Las Vegas. “Recent drug approvals, including Leqembi and Kisunla, have highlighted how essential biomarkers are for identifying appropriate trial participants and demonstrating target engagement. As the field increasingly moves beyond amyloid and toward diverse disease mechanisms, continued progress will depend on robust, next-generation biomarkers that support tailored combination approaches.”

Robust biomarkers are essential for earlier and more accessible detection, improved clinical trial enrollment, and more efficient evaluation of new therapies. The ADDF’s Diagnostics Accelerator fast-tracks the development of accessible, scalable biomarkers to support earlier, more personalized intervention. As Alzheimer’s science advances, this initiative is focused on delivering the next generation of diagnostics capable of identifying co-pathologies, guiding tailored prevention and treatment strategies, and enabling combination therapies, laying the foundation for a new era of precision medicine in Alzheimer’s care.