NCT04619420

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

A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study With a Long-Term Extension Treatment Period to Assess the Efficacy and Safety of JNJ-63733657, an Anti-tau Monoclonal Antibody, in Participants With Early Alzheimer's Disease

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 523 (actual)
• Sponsor: Janssen Research & Development, LLC · Industry
• Sex: All
• Age: 55 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Alzheimer Disease
• Cognitive Dysfunction
• Dementia

Interventions

Type	Name	Description
DRUG	JNJ-63733657	JNJ-63733657 low or high dose will be administered by IV infusion.
DRUG	Placebo	Placebo matching to JNJ-63733657 will be administered by IV infusion.

Timeline

• Start date: 2021-01-06
• Primary completion: 2025-10-17
• Completion: 2026-03-03
• First posted: 2020-11-06
• Last updated: 2026-04-03

Locations

122 sites across 10 countries: United States, Australia, Belgium, Canada, France, Japan, Netherlands, Spain, Sweden, United Kingdom

Regulatory

• FDA-regulated drug study