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CompletedPhase 1

A Study to Evaluate the Effects of JNJ-54861911 on Amyloid Beta Processing in Cerebrospinal Fluid and Plasma in Patients With Prodromal Alzheimer's Disease

A Double-blind, Placebo-Controlled, Randomized, 4-Week, Multiple-Dose, Proof-of-Mechanism Study in Subjects With Prodromal Alzheimer's Disease Investigating the Effects of JNJ-54861911 on Aβ Processing in CSF and Plasma

Lead sponsor

Janssen Research & Development, LLC

Asset

Atabecestat

Listed sites

Recruiting sites

Enrollment

actual

Study population

Alzheimer’s disease

Key I/E criteria

•Amyloid biomarker required (PET/CSF)•Tau biomarker required (PET/CSF)

Primary endpoints

•Levels of amyloid beta 1-40 in cerebrospinal (CSF) after treatment at•Levels of amyloid beta 1-40 in plasma after treatment at the intended target•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

Eudract number2013-003036-69

Secondary ID54861911ALZ1005Janssen Research & Development, LLC

Org study IDCR103012

NCT IDNCT01978548

Timeline

Milestones

Study first posted2013-11-07estimated

Study start2013-12 (month precision)

Primary completion2015-04actual (month precision)

Study completion2015-04actual (month precision)

Last update posted2015-06-25estimated

Assets

Drug assets

Atabecestat

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age50 Years

Maximum age90 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Patients must have had sufficient education or work experience to exclude mental retardation

•Patients must have an abnormal cognitive performance consistent with mild cognitive impairment based on the computerized neuropsychological test battery (CANTAB Elect) that can effectively screen patients and identify cognitive deficits consistent with mild cognitive impairment

•Patients must have evidence of amyloid deposition by means of either 1) low cerebrospinal fluid amyloid beta 1-42 (CSF amyloid beta 1-42) levels and elevated CSF p-Tau and/or total tau levels at screening (cut off values for CSF amyloid beta 1-42 and CSF p-tau and/or total tau will be based on the values established by the Clinical Neurochemistry Lab, Sahlgrenska University Hospital, Mölndal, Sweden and specified in a separate lab manual) or 2) a positive 18F-flutematol amyloid positron emission tomography (PET) amyloid scan at screening (optional depending on the site's PET capability) or both

•Patients must have a body mass index (BMI=weight/height²) between 18 and 35 kg/m2, inclusive, at screening

•Women must be postmenopausal, permanently sterilized or otherwise be incapable of pregnancy

•Must adhere to required contraception during and for 3 months after study

•Patients must be otherwise healthy for their age group or medically stable with or without medication

•Patients must be able to be compliant with self-administration of medication

•Patients must be able to swallow drug as a whole

Exclusion criteria

•Patient has evidence of brain disease, other than Alzheimer's Disease (AD), or any other abnormality (e.g. folic acid/Vitamin B12 deficiency) that could explain the cognitive deficit (including, but not limited to vascular encephalopathy or strokes, as imaged by cerebral MRI and Major Depression, as defined by DSM-IV criteria)

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

•Patient has evidence of familial autosomal dominant AD

•Patient has a history of substance or alcohol abuse

•Relevant history of lower back pain or scoliosis and/or major (lumbar) back surgery

•Patient is allergic to local anesthetics and/or iodine or chlorhexidine

•Patient has taken aspirin (even low dose) within 5 days prior to lumbar puncture (screening or Day 1)

•Patient has taken Low Molecular Weight Heparin (LMWH) within 12 hours prior to lumbar puncture (screening or Day 1)

•Patient has taken any anticoagulant treatment (e.g. warfarin; besides LMWH described above) within 1 week prior to lumbar puncture (screening or Day 1)

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

Amyloid biomarkers

Safety / tolerability / PK

Fluid / digital biomarkers

Amyloid biomarkers

6 endpoints

Primary/protocol endpoint

Levels of amyloid beta 1-40 in cerebrospinal (CSF) after treatment at the intended target dose range

Time frame:Up to 4 weeks

descriptive

Primary/protocol endpoint

Levels of amyloid beta 1-40 in plasma after treatment at the intended target dose range

Time frame:Up to 4 weeks

descriptive

Secondary/protocol endpoint

Levels of amyloid beta fragments (amyloid beta 1-37, 1-38, and 1-42) in cerebrospinal fluid after treatment at the intended target dose range

Time frame:Up to 4 weeks

descriptive

Secondary/protocol endpoint

Levels of amyloid beta fragments (amyloid beta 1-37, 1-38, and 1-42) in plasma after treatment at the intended target dose range

Time frame:Up to 4 weeks

descriptive

Secondary/protocol endpoint

Levels of amyloid precursor protein (APP) fragments (soluble amyloid precursor protein α [sAPPalpha], sAPPbeta, totalAPP) in CSF after treatment at the intended target dose range

Time frame:Up to 4 weeks

descriptive

Secondary/protocol endpoint

Compare the relationship of amyloid beta 1-40 levels in plasma and cerebrospinal fluid after treatment at the intended target dose range

Time frame:Up to 4 weeks

descriptive

Fluid / digital biomarkers

1 endpoint

Primary/protocol endpoint

Cerebrospinal fluid exposure of JNJ-54861911

Time frame:Up to 4 weeks

descriptive

Safety / tolerability / PK

5 endpoints

Primary/protocol endpoint

Maximum observed plasma concentration (Cmax) of JNJ-54861911

Time frame:Up to 4 weeks

concentration, descriptive

Primary/protocol endpoint

Time to reach maximum observed plasma concentration of JNJ-54861911

Time frame:Up to 4 weeks

time to event, event

Primary/protocol endpoint

Area under the plasma concentration time curve (AUC) from 0 to t hours of JNJ-54861911

Time frame:Up to 4 weeks

concentration, descriptive

Primary/protocol endpoint

Half-life of JNJ-54861911

Time frame:Up to 4 weeks

concentration, descriptive

Primary/protocol endpoint

The number of volunteers who experience 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

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.