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JNJ-64042056

Phase 2

Alzheimer Disease | Small molecule | Neurology |Johnson & Johnson|Last Updated: Jul 6, 2026

Success Probability
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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)
LOWJul 6, 2026NCT06544616lastUpdatePostDate: changed
LOWJul 6, 2026NCT06544616lastUpdatePostDate: changed
LOWJun 5, 2026NCT06544616Completion: 2026-12-22 → 2027-01-05
LOWJun 5, 2026NCT06544616Completion: 2026-12-22 → 2027-01-05
LOWJun 5, 2026NCT06544616Completion: 2026-12-22 → 2027-01-05
LOWJun 5, 2026NCT06544616Completion: 2026-12-22 → 2027-01-05
HIGHMay 26, 2026NCT06544616Enrollment: 498 → 55
LOWMay 24, 2026NCT06544616studyFirstPostDate: changed