← Trials/Trial dossier/NCT03587376

CompletedPhase EARLY_1

Characterization of T-Cell Response in Participants Previously Treated With JNJ-54861911 (Atabecestat)

Characterization of T-Cell Response in Subjects Previously Treated With JNJ-54861911 (Atabecestat)

Lead sponsor

Janssen Research & Development, LLC

Asset

Atabecestat

Listed sites

Recruiting sites

Enrollment

actual

Study population

Alzheimer’s disease

Key I/E criterion

•Age 50-85

Primary endpoint

•Atabecestat-Specific T-cell Mediated Inflammatory Immune Response

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 number2018-000403-17European Medicines Agency (EudraCT)

Secondary ID54861911ALZ0002Janssen Research & Development, LLC

Org study IDCR108462

NCT IDNCT03587376

Timeline

Milestones

Study start2018-05-30actual

Study first posted2018-07-16actual

Primary completion2018-08-23actual

Study completion2018-08-23actual

Last update posted2025-04-27actual

Assets

Drug assets

Atabecestat

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age50 Years

Maximum age85 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Participant who received and discontinued atabecestat in one of the following prior trials (54861911ALZ2002, 54861911ALZ2003, or 54861911ALZ2004)

•Must sign an informed consent form (ICF) indicating that he or she understands the purpose of, and procedures required for, the study and is willing to participate in the study

•Willing and able to adhere to the prohibitions and restrictions specified for this study

Exclusion criteria

•Anemic based on the last blood draw in the prior atabecestat trial

•Donated more than (>) 450 milliliter (mL) of blood in the past 3 months

•Currently participating in an atabecestat study (54861911ALZ2002, 54861911ALZ2003, or 54861911ALZ2004)

Endpoints (2)

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.

Other (unclassified)

2 endpoints

Primary/protocol endpoint/low confidence

Number of Participants with Atabecestat-Specific T-cell Mediated Inflammatory Immune Response

Time frame:Day 1

event count, event

Secondary/protocol endpoint/low confidence

Participants T-cell Receptor (TCR) Sequencing

Time frame:Day 1

descriptive

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.