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Active Not RecruitingNCT06544616

A Study of JNJ-64042056 in Participants With Preclinical Alzheimer's Disease

A Multicenter, Randomized, Placebo-Controlled, Double-Blind, Parallel-Group Study, to Assess Efficacy, Safety and Immunogenicity of JNJ-64042056, a Phosphorylated Tau Targeted Active Immunotherapy, in Participants With Preclinical Alzheimer's Disease

Status
Active Not Recruiting
Phase
Phase 2
Study type
Interventional
Enrollment
498 (estimated)
Sponsor
Janssen Pharmaceutica N.V., Belgium · Industry
Sex
All
Age
55 Years – 75 Years
Healthy volunteers
Not accepted

Summary

The purpose of this study is to assess the effect of JNJ-64042056 on cognitive decline, as measured by Preclinical Alzheimer's disease Cognitive Composite 5 (PACC-5) compared with placebo.

Conditions

Interventions

TypeNameDescription
DRUGJNJ-64042056JNJ-64042056 will be administered intramuscularly.
DRUGPlaceboPlacebo will be administered intramuscularly.

Timeline

Start date
2024-07-22
Primary completion
2031-07-17
Completion
2032-07-16
First posted
2024-08-09
Last updated
2026-02-17

Locations

90 sites across 9 countries: United States, Australia, Belgium, France, Germany, Japan, Spain, Sweden, United Kingdom

Regulatory

Source: ClinicalTrials.gov record NCT06544616. Inclusion in this directory is not an endorsement.