CompletedPhase 2

A Safety and Tolerability Study of JNJ-54861911 in Participants With Early Alzheimer's Disease

A Phase 2a Randomized, Double-blind, Placebo-Controlled, Parallel-Group, Multi-center Study Investigating the Safety and Tolerability of JNJ-54861911 in Subjects With Early Alzheimer's Disease

Lead sponsor

Janssen Research & Development, LLC

Asset

Atabecestat

Listed sites

Recruiting sites

Enrollment

114

actual

Study population

Alzheimer’s disease

Key I/E criteria

•prodromal AD•Amyloid biomarker required (PET/CSF)

Primary endpoint

•Adverse Events (AEs) or Serious Adverse Events (SAEs)

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 number2014-002159-24

Secondary ID54861911ALZ2002Janssen Research & Development, LLC

Org study IDCR105240

NCT IDNCT02260674

Timeline

Milestones

Study first posted2014-10-09estimated

Study start2014-11 (month precision)

Primary completion2016-06actual (month precision)

Study completion2016-06actual (month precision)

Last update posted2025-04-29actual

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

•Participants in the early alzheimer's disease (AD) spectrum must have a global Clinical Dementia Rating Scale( CDR) score of 0 (asymptomatic at risk for AD) to 0.5 prodromal AD (pAD) inclusive

•Participants must have evidence of amyloid pathology by means of either:

a)low Cerebrospinal Fluid (CSF) ABeta 1-42 levels at screening;

b)a positive amyloid positron emission tomography (PET) scan at screening (depending on the site's PET capability) by visual read

•Participants must have a body mass index between 18 and 35 kilogram per square meter (kg/m^2), inclusive, at screening

•Participants must be otherwise healthy for their age group or medically stable with or without medication on the basis of physical examination, medical history, vital signs, and 12-lead ECG performed at screening or at baseline. If there are abnormalities, they must be consistent with the underlying illness in the study population and not a potential cause of cognitive impairment, with written concurrence with the sponsor's medical monitor

•Before randomization, a woman must be not of childbearing potential: postmenopausal (greater than or equal to [>=] 50 years of age with amenorrhea for at least 12 months; permanently sterilized [e.g., tubal occlusion, hysterectomy, bilateral salpingectomy]); or otherwise be incapable of pregnancy. In case of questionable status qualified personal of the sponsor should be consulted to decide on the potential for inclusion of the participant

Exclusion criteria

•Participant has evidence of any brain disease, other than potential very early signs of AD (e.g. mild hippocampal atrophy) or typical age-related changes (e.g. mild white matter hyperintensity on magnetic resonance imaging [MRI]) or any other abnormality (e.g. folic acid/Vitamin B12 deficiency) that could explain a possible cognitive deficit (including, but not limited to vascular encephalopathy or strokes including lacuna's (as imaged by cerebral MRI) and Major Depression (as defined by most current Diagnostic and Statistical Manual of Mental Disorders (DSM) criteria)

•Participant has evidence of familial autosomal dominant AD. (Inclusion can be made upon written confirmation by sponsor, when the mutation is known and deemed not to be modulating Beta-secretase [BACE] cleavage)

•Participant with history or presence of significant depression as defined by the most current DSM criteria

•Participant has a clinically significant abnormal physical- or neurological examination, vital signs at screening or baseline (Day 1 predose)

•Participant has a history of or current liver or renal insufficiency; clinically significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, hematologic, rheumatologic, psychiatric, or metabolic disturbances (e.g. unstable situation needing monitoring or regular dose adaptations)

Endpoints (8)

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

Amyloid biomarkers

Fluid / digital biomarkers

Safety / tolerability / PK

Amyloid biomarkers

3 endpoints

Secondary/protocol endpoint

Percent Change From Baseline in Cerebrospinal Fluid (CSF) Amyloid Beta (ABeta) (1-37, 1-38, 1-40, 1-42) Levels and Soluble Amyloid Precursor Protein (sAPP) Fragments (sAPP-alpha, sAPP-beta), Total sAPP Levels

Time frame:Baseline and Month 6

percent change from baseline, improvement

Secondary/protocol endpoint

Percent Change From Baseline in Plasma ABeta 1-40 Levels and sAPP Fragments (sAPP-alpha, sAPP-beta), Total sAPP Levels

Time frame:Baseline and Month 6 (Day 168)

percent change from baseline, improvement

Secondary/protocol endpoint

Relationship Between Changes in CSF and Plasma ABeta Species and sAPP Fragments With Safety

Time frame:Month 1 up to Month 6

concentration, descriptive

Fluid / digital biomarkers

3 endpoints

Secondary/protocol endpoint

Relationship Between Dose and Exposure of JNJ-54861911 With Safety

Time frame:Month 1 up to Month 6

concentration, descriptive

Secondary/protocol endpoint

Time to Reach the Maximum Plasma or CSF concentration (Tmax)

Time frame:Pre-dose on Day 1, post-dose on Day 28, 56, 84, 112, 140 and 168

time to event, event

Secondary/protocol endpoint

Area Under the Plasma/CSF Concentration-time Curve From Time 0 to tau Hours Post Dosing (AUCtau)

Time frame:Pre-dose on Day 1, post-dose on Day 28, 56, 84, 112, 140 and 168

concentration, descriptive

Safety / tolerability / PK

2 endpoints

Primary/protocol endpoint

Number of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs)

Time frame:up to 10 months

event count, event

Secondary/protocol endpoint

Maximum Plasma Concentration (Cmax) of JNJ-54861911

Time frame:Pre-dose on Day 1, post-dose on Day 28, 56, 84, 112, 140 and 168

concentration, descriptive

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

Novak G, Streffer JR, Timmers M, Henley D, Brashear HR, Bogert J, Russu A, Janssens L, Tesseur I, Tritsmans L, Van Nueten L, Engelborghs S. Long-term safety and tolerability of atabecestat (JNJ-54861911), an oral BACE1 inhibitor, in early Alzheimer's disease spectrum patients: a randomized, double-blind, placebo-controlled study and a two-period extension study. Alzheimers Res Ther. 2020 May 14;12(1):58. doi: 10.1186/s13195-020-00614-5.
PMID32410694via DERIVED

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.