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JNJ-64042056

Phase 2

Alzheimer Disease | Small molecule | Neurology |Johnson & Johnson|Last Updated: Aug 28, 2026

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment55

FDA Designations

No designations recorded

Clinical trial landscape

JNJ-64042056 · 1 trial · 1 indication

Phase 2 1
NCT06544616A Study of JNJ-64042056 in Participants With Preclinical Alzheimer's DiseaseAlzheimer Disease
ACTIVE NOT_RECRUITING55 Analytics
PHASE2ACTIVE NOT_RECRUITING
A Study of JNJ-64042056 in Participants With Preclinical Alzheimer's Disease
Alzheimer DiseaseUnlock trial analytics

Study Endpoints

Primary Endpoints

Change From Baseline in Brain Tau Burden as Measured by Tau PET in Specified Regions of Interest (ROI)
Baseline up to Week 102

Change from baseline in brain tau burden, as measured by tau PET (including but not limited to Braak I-VI ROIs, tau naive composite ROI, Connection Rank ROI, and New Tau Composite ROI Volume) will be reported.

Secondary Endpoints

Levels of IgG Titers Against Enriched Paired Helical Filaments (ePHF), p-tau and tau in Serum
Up to Week 102
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Up to Week 104
Number of Participants With Reactogenicity
Up to Week 78
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Arm A: JNJ-64042056EXPERIMENTALParticipants will receive intramuscular (IM) injection of JNJ-64042056 from Week 0 up to a maximum of Week 76.
Arm B: PlaceboPLACEBO_COMPARATORParticipants will receive IM injection of placebo from Week 0 up to a maximum of Week 76.

Interventions

NameTypeDescription
JNJ-64042056DRUGJNJ-64042056 will be administered intramuscularly.
PlaceboDRUGPlacebo will be administered intramuscularly.
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Eligibility Criteria

Age Range55 Years to 75 Years
SexALL
Healthy VolunteersNo
Study Sites90

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...

Countries:United StatesAustraliaBelgiumFranceGermanyJapanSpainSwedenUnited Kingdom
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Recent Changes (Last 90 Days)

LOWAug 28, 2026NCT06544616lastUpdatePostDate: changed
LOWAug 28, 2026NCT06544616lastUpdatePostDate: changed
LOWJul 31, 2026NCT06544616lastUpdatePostDate: changed
LOWJul 31, 2026NCT06544616lastUpdatePostDate: changed
LOWJul 6, 2026NCT06544616lastUpdatePostDate: changed
LOWJul 6, 2026NCT06544616lastUpdatePostDate: changed

Frequently asked questions about JNJ-64042056

What is JNJ-64042056 used for?

JNJ-64042056 is an investigational small molecule being developed for Alzheimer's disease. It is currently in Phase 2 clinical development for the treatment of preclinical Alzheimer's disease, meaning it is being studied in participants who have not yet developed symptoms but may be at risk for the condition.

Who makes JNJ-64042056?

JNJ-64042056 is being developed by Johnson & Johnson, a multinational pharmaceutical company traded on the New York Stock Exchange under the ticker symbol JNJ. The company is currently conducting a Phase 2 clinical trial of this investigational drug for Alzheimer's disease.

What phase is JNJ-64042056 in?

JNJ-64042056 is in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still being studied in clinical trials. The current Phase 2 trial is active but not recruiting participants.

What clinical trials is JNJ-64042056 in?

JNJ-64042056 is being studied in a Phase 2 clinical trial with the identifier NCT06544616. This randomized, double-blind, placebo-controlled study is evaluating the drug in 55 participants with preclinical Alzheimer's disease across multiple countries, including the United States, Australia, Belgium, France, Germany, Japan, Spain, Sweden, and the United Kingdom.

Is JNJ-64042056 the same as any other drug?

No alternative names for JNJ-64042056 have been disclosed. The drug is identified solely by its development code JNJ-64042056 in the clinical trial registry. It is an investigational small molecule being studied for Alzheimer's disease.