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A Study of JNJ-64042056 in Participants With Preclinical Alzheimer's Disease | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGPHASE2

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

NCT06544616•Janssen Pharmaceutica N.V., Belgium

View on ClinicalTrials.gov

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.

Eligibility

Age

55 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Elevated brain tau pathology defined as Braak 3 region of interest standardized uptake value ratio (ROI SUVR) greater than (\>) 1.1 (or equivalent based on emerging data) on a screening tau PET scan, reviewed centrally by a qualified reader to enrich for probability of disease progression during the study
•Clinical Dementia Rating (CDR) global score of 0 at screening and baseline
•Mini Mental State Examination (MMSE) greater than or equal to (\>=) 27 (with educational adjustment) at screening
•Able to read and write and with a minimum 5 years of formal education as reported by participant and study partner at screening
•A participant must be of non-childbearing potential

Exclusion Criteria

•History consistent with or known autosomal dominant AD (mutation identified in the family and/or participant)
•Fulfills diagnostic criteria for Alzheimer's Dementia or non-Alzheimer's Dementia, including, but not limited to Frontotemporal Dementia (FTD), Diffuse Lewy Body Dementia (DLBD), Vascular Dementia (VAD), alcoholic dementia, Parkinson's dementia, Korsakov, Creutzfeldt-Jakob or other prion diseases, Posterior Cortical Atrophy
•Diagnosis of Mild Cognitive Impairment (MCI)
•Vitamin B12 or folate levels below the central laboratory lower limit of normal, unless the investigator determines that supplementation is not required after randomization
•History of or current neurological disease other than preclinical AD that may make interpretation of possible new neurological signs or symptoms difficult

Locations (90)

Xenoscience Inc.

Phoenix, Arizona, United States

Irvine Clinical Research

Irvine, California, United States

Esperanza Clinical

Murrieta, California, United States

Artemis Institute for Clinical Research

Riverside, California, United States

Artemis Institute for Clinical Research

San Diego, California, United States

Yale University School Of Medicine

New Haven, Connecticut, United States

JEM Research LLC

Atlantis, Florida, United States

Excel Medical Clinical Trials, LLC

Boca Raton, Florida, United States

K2 Medical Research Winter Garden

Clermont, Florida, United States

Clinical NeuroScience Solutions Inc

Jacksonville, Florida, United States

Key Dates

Start Date

July 22, 2024

Primary Completion Date

July 17, 2031

Completion Date

July 16, 2032

Last Updated

February 17, 2026

Enrollment

498

ESTIMATED participants

Conditions

Preclinical Alzheimer's Disease

Interventions

JNJ-64042056

DRUG

Placebo

DRUG

AHEAD 3-45 Study: A Study to Evaluate Efficacy and Safety of Treatment With Lecanemab in Participants With Preclinical Alzheimer's Disease and Elevated Amyloid and Also in Participants With Early Preclinical Alzheimer's Disease and Intermediate Amyloid

NCT04468659

Preclinical Alzheimer's DiseaseEarly Preclinical Alzheimer's Disease

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NOT_YET_RECRUITINGPHASE1

AV-1980R (Tau Vaccine) in Preclinical Alzheimer's Disease (TAURUS-1980)

NCT07158905

Alzheimer DiseasePreclinical Alzheimer's Disease

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 17, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

AHEAD 3-45 Study: A Study to Evaluate Efficacy and Safety of Treatment With Lecanemab in Participants With Preclinical Alzheimer's Disease and Elevated Amyloid and Also in Participants With Early Preclinical Alzheimer's Disease and Intermediate Amyloid

AV-1980R (Tau Vaccine) in Preclinical Alzheimer's Disease (TAURUS-1980)

TRC-PAD Program: In-Clinic Trial-Ready Cohort

Concurrent Aerobic Exercise and Virtual Reality Cognitive Training

Amyloid Prediction in Early Stage Alzheimer's Disease Through Speech Phenotyping - PAST Extension