A Study of JNJ-63733657 in Participants With Early Alzheimer's Disease

NCT04619420 ↗

Phase 2 Terminated 523 enrolled Janssen Research & Development, LLC

RandomizedParallel-groupQuadruple-blindTreatment

Summary

The primary purpose of this study is to evaluate the effect of JNJ-63733657 versus placebo on clinical decline as measured by the Integrated Alzheimer's Disease Rating Scale (iADRS), a composite of cognition and function.

Timeline

Start: 2021-01-06
Primary completion: 2025-10-17
Completion: 2026-03-03

Outcome

Missed primary endpoint

Stopped: “Posdinemab did not achieve statistical significance in slowing clinical decline”

release “Following a scheduled review that determined posdinemab did not achieve statistical significance in slowing clinical decline, the Auτonomy study will be discontinued.” jnj.com ↗

Publications

Perez-Ruixo C, Li L, Galpern WR, Perez-Ruixo JJ. Mechanistic Population Pharmacokinetic-Pharmacodynamic Model of the Tau-Targeted Antibody Posdinemab in Healthy Participants and Participants with Alzheimer's Disease. Clin Pharmacol Ther. 2026 Apr;119(4):979-989. doi: 10.1002/cpt.70173. Epub 2025 Dec 22.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	posdinemab	Monoclonal antibody	—	Intravenous