Reτain

Active not recruitingPhase 2

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

Lead sponsor

Janssen Pharmaceutica N.V., Belgium

Asset

JNJ-64042056

Listed sites

Recruiting sites

Enrollment

actual

Study population

Alzheimer’s disease

Key I/E criteria

•Tau biomarker required (PET)•CDR global 0•MMSE ≥27•Study partner/caregiver required

Primary endpoint

•Brain Tau Burden

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Registry2023-505096-68-00EUCT number

Org study ID64042056ALZ2001

NCT IDNCT06544616

Timeline

Milestones

Study start2024-07-22actual

Study first posted2024-08-09actual

Last update posted2026-07-06actual

Primary completion2026-12-22estimated

Study completion2027-01-05estimated

Assets

Drug assets

JNJ-64042056

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age55 Years

Maximum age75 Years

SexAll

Healthy volunteersNot accepted

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

Endpoints (9)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Safety / tolerability / PK

Tau biomarkers

Other (unclassified)

Behavior / neuropsychiatric

Neuroimaging

Behavior / neuropsychiatric

1 endpoint

Secondary/protocol endpoint

Change From Baseline in Columbia-Suicidality Severity Rating Scale (C-SSRS)

Time frame:Baseline up to Week 102

change from baseline, improvement

Tau biomarkers

2 endpoints

Primary/protocol endpoint

Change From Baseline in Brain Tau Burden as Measured by Tau PET in Specified Regions of Interest (ROI)

Time frame:Baseline up to Week 102

change from baseline, improvement

Secondary/protocol endpoint

Levels of IgG Titers Against Enriched Paired Helical Filaments (ePHF), p-tau and tau in Serum

Time frame:Up to Week 102

descriptive

Neuroimaging

1 endpoint

Secondary/protocol endpoint

Change From Baseline in Magnetic Resonance Imaging (MRI) Findings

Time frame:Baseline up to Week 102

change from baseline, improvement

Safety / tolerability / PK

3 endpoints

Secondary/protocol endpoint

Number of Participants With Treatment Emergent Adverse Events (TEAEs)

Time frame:Up to Week 104

event count, event

Secondary/protocol endpoint

Number of Participants with Vital Signs Abnormalities

Time frame:Up to Week 102

event count, event

Secondary/protocol endpoint

Change from Baseline in Electrocardiogram (ECG) Values

Time frame:Baseline up to Week 102

change from baseline, event

Other (unclassified)

2 endpoints

Secondary/protocol endpoint/low confidence

Number of Participants With Reactogenicity

Time frame:Up to Week 78

event count, event

Secondary/protocol endpoint/low confidence

Number of Participants with Clinical Laboratory Abnormalities

Time frame:Up to Week 102

event count, event

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.