CompletedPhase 1

Study Investigating the Effects of JNJ-54861911 on Amyloid-beta Processing in Cerebrospinal Fluid (CSF) and Plasma in Japanese Participants Asymptomatic at Risk for Alzheimer Dementia

A Double-blind, Placebo-controlled, Randomized, 4-Week, Multiple-dose, Proof of Mechanism (POM) Study in Japanese Subjects Asymptomatic at Risk for Alzheimer Dementia (ARAD) Investigating the Effects of JNJ-54861911 on A-beta Processing in Cerebrospinal Fluid (CSF) and Plasma

Lead sponsor

Janssen Pharmaceutical K.K.

Asset

Atabecestat

Listed sites

Recruiting sites

Enrollment

actual

Study population

Alzheimer’s disease

Key I/E criterion

•Age 65-85

Primary endpoints

•Levels of Amyloid (A)-beta1-40 in Cerebrospinal Fluid (CSF) After Treatment•Levels of A-beta1-40 in Plasma After Treatment at the Intended Target Dose Range•Cmax of JNJ 54861911

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

Secondary ID54861911ALZ1008Janssen Pharmaceutical K.K., Japan

Org study IDCR106397

NCT IDNCT02360657

Timeline

Milestones

Study first posted2015-02-10estimated

Study start2015-02-16actual

Primary completion2015-09-08actual

Study completion2015-09-08actual

Last update posted2019-02-04actual

Assets

Drug assets

Atabecestat

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age65 Years

Maximum age85 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Participant must have had sufficient education or work experience to exclude mental retardation based on Diagnostic and Statistical Manual of Mental Disorders 4th edition, Text Revision (DSM-IV-TR) and must be able to read and write and must have adequate hearing and visual acuity to complete the required psychometric tests

•Participant must have a Clinical Dementia Rating Scale- Japanese version (CDR-J) score of '0' and as such rated as normal

•Participant must have evidence of amyloid deposition as demonstrated by low Cerebrospinal Fluid (CSF) Amyloid (A)-beta 1-42 levels at Screening

•Participant must have a body mass index between 18 and 35 kilogram per square meter, inclusive, at Screening

•Participant 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 electrocardiogram (ECG) performed at Screening or at Baseline

Exclusion criteria

•Participant has evidence of any brain disease other than potential very early signs of Alzheimer's disease (AD) or typical age related changes, or any other abnormality that could explain a possible cognitive deficit

•Participant has been diagnosed with dementia due to AD, due to other diseases, or with AD and contribution of other disorders (mixed dementia)

•Participant has evidence of familial autosomal dominant AD

•Participant has any contra-indications for Magnetic Resonance Imaging (MRI) (for example, prostheses, implants, claustrophobia, pacemakers, and others)

•Participant has a clinically significant abnormal physical- or neurological examination, vital signs or 12-lead ECG (including QTc greater than 450 millisecond for males and females, left bundle branch block, atrio-ventricular [AV] block second degree or higher, permanent pacemaker or implantable cardioverter defibrillator [ICD]) at Screening or Baseline, which in the opinion of the investigator is not appropriate and reasonable for the population under study

Endpoints (12)

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

Safety / tolerability / PK

Fluid / digital biomarkers

Other (unclassified)

Amyloid biomarkers

2 endpoints

Primary/protocol endpoint

Levels of Amyloid (A)-beta1-40 in Cerebrospinal Fluid (CSF) After Treatment at the Intended Target Dose Range

Time frame:Up to 4 weeks

descriptive

Secondary/protocol endpoint

Levels of Soluble Amyloid Precursor Protein (APP) Fragments in CSF (sAPP-alpha, sAPP-beta, totalAPP) After Treatment at the Intended Target Dose Range

Time frame:Up to 4 weeks

descriptive

Fluid / digital biomarkers

3 endpoints

Primary/protocol endpoint

Cerebrospinal Fluid Exposure of JNJ-54861911

Time frame:Up to 4 weeks

descriptive

Secondary/protocol endpoint

Levels of A-beta Fragments (A-beta1-37, A-beta1-38, and A-beta1-42) in CSF After Treatment at the Intended Target Dose Range

Time frame:Up to 4 weeks

descriptive

Secondary/protocol endpoint

Compare the Relationship of A-beta1-40 Levels in Plasma and CSF After Treatment at the Intended Dose Range

Time frame:Up to 4 weeks

descriptive

Safety / tolerability / PK

4 endpoints

Primary/protocol endpoint

Maximum Observed Plasma Concentration (Cmax) of JNJ 54861911

Time frame:Up to 4 weeks

concentration, descriptive

Primary/protocol endpoint

Minimum Observed Plasma Concentration (Cmin) of JNJ 54861911

Time frame:Up to 4 weeks

concentration, descriptive

Primary/protocol endpoint

Time to Reach Maximum Observed Concentration (Tmax) of JNJ 54861911

Time frame:Up to 4 weeks

time to event, event

Primary/protocol endpoint

The Number of Participants who Experienced Adverse Events as a Measure of Safety and Tolerability of JNJ-54861911 After Multiple-Dose Administration in the Anticipated Target Dose Range

Time frame:Up to 4 weeks

event count, event

Other (unclassified)

3 endpoints

Primary/protocol endpoint/low confidence

Levels of A-beta1-40 in Plasma After Treatment at the Intended Target Dose Range

Time frame:Up to 4 weeks

descriptive

Primary/protocol endpoint/low confidence

Area Under the Curve From Time Zero to end of Dosing Interval (AUCtau)

Time frame:Up to 4 weeks

concentration, descriptive

Secondary/protocol endpoint/low confidence

Levels of A-beta Fragments (A-beta1-37, A-beta1-38, and A-beta1-42) in Plasma After Treatment at the Intended Target Dose Range

Time frame:Up to 4 weeks

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

Timmers M, Streffer JR, Russu A, Tominaga Y, Shimizu H, Shiraishi A, Tatikola K, Smekens P, Borjesson-Hanson A, Andreasen N, Matias-Guiu J, Baquero M, Boada M, Tesseur I, Tritsmans L, Van Nueten L, Engelborghs S. Pharmacodynamics of atabecestat (JNJ-54861911), an oral BACE1 inhibitor in patients with early Alzheimer's disease: randomized, double-blind, placebo-controlled study. Alzheimers Res Ther. 2018 Aug 23;10(1):85. doi: 10.1186/s13195-018-0415-6.
PMID30134967via 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.