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Autonomy

TerminatedPhase 2

A Study of JNJ-63733657 in Participants With Early Alzheimer's Disease

A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study With a Long-Term Extension Treatment Period to Assess the Efficacy and Safety of JNJ-63733657, an Anti-tau Monoclonal Antibody, in Participants With Early Alzheimer's Disease

Asset

JNJ-63733657

Listed sites

122

Recruiting sites

-

Enrollment

523

actual

Study population

Alzheimer’s disease

Key I/E criteria

•Tau biomarker required (PET)•Study partner/caregiver required

Primary endpoint

•ADAS-Cog

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

Eudract number2020-000116-30
Registry2022-501188-42-00EUCT number
Secondary ID63733657ALZ2002Janssen Research & Development, LLC
Org study IDCR108832
NCT IDNCT04619420

Timeline

Milestones

Study first posted2020-11-06actual
Study start2021-01-06actual
Primary completion2025-10-17actual
Study completion2026-03-03actual
Last update posted2026-04-03actual

Assets

Drug assets

JNJ-63733657

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age55 Years
Maximum age80 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•Early Alzheimer's disease (AD): Gradual and progressive subjective decline in the participant's cognition over at least the past 6 months, as reported by the participant and informant (study partner) and Clinical Dementia Rating-Global Score (CDR-GS) of 0.5 and memory box score greater than or equal to (>=) 0.5 at screening
•Participants must have positive tau PET results
•Able to read and write and with a minimum 5 years of formal education as reported by participant and study partner at screening
•Have a designated study partner who has adequate literacy to participate and be judged to have high likelihood of completing the study with the participant
•Male participants must agree not to donate sperm for the purpose of reproduction during the study and up to 16 weeks after receiving the last dose of study intervention

Exclusion criteria

•Participants with CDR GS >=2 at predose baseline Clinical Dementia Rating (CDR) administration
•Participants who fulfill diagnostic criteria for Mild Cognitive Impairment (MCI) or dementia/mild or major neurocognitive disorder suspected to be due to any etiology other than AD (example, Parkinson's disease, cerebrovascular disease, normal pressure hydrocephalus, head injury, drug or alcohol abuse/dependence, anoxic brain injury, (Et cetera[etc])
•Geriatric Depression Scale (GDS) 30 score greater than (>) 12
•Hachinski Ischemic Scale (HIS) >4
•Has received medications that affect the central nervous system (CNS), except treatments for AD, for less than 2 months; that is, doses of chronic medications that effect the CNS should be stable for at least 2 months before the start of screening. If a participant has recently stopped a chronic medication that effects the CNS, he or she must have discontinued treatment at least 2 months before the start of screening. Chronic use of benzodiazepines is not permitted

Endpoints (22)

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

Global cognition
6
Safety / tolerability / PK
5
Other (unclassified)
4
Behavior / neuropsychiatric
2
Tau biomarkers
2
Function / daily living
1
Neuroimaging
1
Fluid / digital biomarkers
1

Global cognition

6 endpoints
Primary/protocol endpoint

Change From Baseline in Integrated Alzheimer's Disease Rating Scale (iADRS) Total Score at Week 104

Time frame:Week 104

ADAS-Cog

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Alzheimer's Disease Assessment Scale Cognitive subscale 13-item version (ADAS-Cog 13) Total Score at Week 104

Time frame:Week 104

ADAS-Cog

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) Total Scale Index Score at Week 88

Time frame:Baseline, Week 88

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in RBANS Indices at Week 88

Time frame:Baseline, Week 88

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Clinical Dementia Rating- Sum of Boxes (CDR-SB) at Week 104

Time frame:Baseline, Week 104

Clinical Dementia Rating-Sum of Boxes (CDR-SB)

change from baseline, improvement

Secondary/protocol endpoint

Percentage of Participants Progressing From Clinical Dementia Rating- Global Score (CDR-GS) 0 to 0.5 or Higher, 0.5 to 1 or Higher, 1 to 2 or Higher, from Baseline to Post-baseline through Week 104

Time frame:From Baseline through Week 104

Clinical Dementia Rating-Sum of Boxes (CDR-SB)

threshold achievement, improvement

Function / daily living

1 endpoint
Secondary/protocol endpoint

Change From Baseline in Alzheimer's Disease Cooperative Study Activities of Daily Living for Mild Cognitive Impairment (ADCS-ADL MCI) Total Score at Week 104

Time frame:Week 104

ADCS-Activities of Daily Living (ADCS-ADL)

change from baseline, improvement

Behavior / neuropsychiatric

2 endpoints
Secondary/protocol endpoint

Change from Baseline in Neuropsychiatric Inventory (NPI) at Week 104

Time frame:Baseline, Week 104

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Secondary/protocol endpoint

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

Time frame:Baseline and Up to 245 Weeks

change from baseline, improvement

Tau biomarkers

2 endpoints
Secondary/protocol endpoint

Change From Baseline in Brain tau Burden as Measured by tau PET at Week 104

Time frame:Baseline, Week 104

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Cerebrospinal Fluid (CSF) concentrations of Total, Free, and Bound p217+tau Fragments at Week 104

Time frame:Baseline, Week 104

change from baseline, improvement

Neuroimaging

1 endpoint
Secondary/protocol endpoint

Changes From Baseline in Brain Magnetic Resonance Imaging (MRI) Safety Findings

Time frame:Baseline and Up to 4.5 years (End of treatment)

descriptive

Fluid / digital biomarkers

1 endpoint
Secondary/protocol endpoint

CSF Concentrations of JNJ-63733657

Time frame:At Weeks 52, 104, 208 (End of Treatment)

concentration, descriptive

Safety / tolerability / PK

5 endpoints
Secondary/protocol endpoint

Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability

Time frame:Up to 245 Weeks

event count, event

Secondary/protocol endpoint

Number of Participants with Treatment-Emergent Adverse Event of Special Interest (AESI)

Time frame:Up to 245 Weeks

event count, event

Secondary/protocol endpoint

Number of Participants with Serious Adverse Events (SAEs) as a Measure of Safety and Tolerability

Time frame:Up to 245 Weeks

event count, event

Secondary/protocol endpoint

Number of Participants with Electrocardiogram (ECG) Abnormalities

Time frame:Up to 245 Weeks

event count, event

Secondary/protocol endpoint

Percentage of Participants with Vital Sign Abnormalities

Time frame:Up to 245 Weeks

threshold achievement, event

Other (unclassified)

4 endpoints
Secondary/protocol endpoint/low confidence

Serum Concentrations of JNJ-63733657

Time frame:At Weeks 4, 8, 12, 16, 20, 24, 36, 52, 76, 104, 128, 156, 180, 208, 232 (End of treatment)

concentration, descriptive

Secondary/protocol endpoint/low confidence

Anti-Drug Antibody to JNJ-63733657

Time frame:Up to 245 Weeks (90 days [+-7 days] after last dose of study intervention)

descriptive

Secondary/protocol endpoint/low confidence

Number of Participants with Clinical Laboratory Abnormalities

Time frame:Up to 245 Weeks

event count, event

Secondary/protocol endpoint/low confidence

Number of Participants with Physical and Neurological Examination Abnormalities

Time frame:Up to 245 Weeks

event count, event

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

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.