CompletedPhase 1

Study to Evaluate the Safety, Tolerability and the Effect of BMS-241027 on Cerebrospinal Fluid Biomarkers in Subjects With Mild Alzheimer's Disease

A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability and the Effect of BMS-241027 on Cerebrospinal Fluid Biomarkers in Subjects With Mild Alzheimer's Disease

Lead sponsor

Bristol-Myers Squibb

Asset

BMS-241027

Listed sites

Recruiting sites

Enrollment

actual

Study population

Alzheimer’s disease

Key I/E criterion

•Age 50-90

Primary endpoints

•Safety assessments•Biomarker Measures

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 number2011-004065-33

Org study IDCN167-003

NCT IDNCT01492374

Timeline

Milestones

Study first posted2011-12-15estimated

Study start2012-02 (month precision)

Primary completion2013-10actual (month precision)

Study completion2013-10actual (month precision)

Last update posted2014-07-24estimated

Assets

Drug assets

BMS-241027

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

•Mild AD Subjects meeting National Institute of Neurological Disorders and Stroke - Alzheimer's Disease Related Disorders Association(NINCDS-ADRDA) and Diagnostic and Statistical Manual of Mental Disorders-Forth Edition, Text Revision (DSM-IV-TR) criteria

•Mini-Mental State Exam (MMSE) Score between 20 \& 26 (inclusive)

•CSF consistent with AD pathology

•Screening brain MRI - normal - commensurate with age or demonstrate atrophy consistent with AD diagnosis (dx); reveal no more than mild white matter disease; up to 2 lacunar infarcts acceptable except in anterior thalamus, genu of internal capsule or basal forebrain; reveal no cortical infarcts; reveal no more than 4 microbleeds; reveal no focal asymmetric lobar atrophy or other findings suggesting primary cause of dementia is attributed to a cause other than AD; reveal no macrohemorrhages (>10 mm)

•Subjects must have reliable study partners

•Men and Women of Non Child Bearing Potentia (WONCBP), ages 50-90 years

Exclusion criteria

•Subjects with any other medical condition other than mild AD that could explain subjects' memory or cognitive deficits

•Subjects diagnosed with moderate or severe AD per DSM-IV criteria

•Subjects with a history (hx) of stroke

•Subjects with a hx of GI illnesses

•Subjects with Vitamin B12 or folate deficiency

•Subjects with any unstable cardiovascular (CV), pulmonary, Gastrointestinal (GI) or hepatic disease within 30 days prior to screening

•Subjects with active liver dx or history of hepatic intolerance

•Subjects with a Geriatric Depression Scale score of ≥ 6 at screening

•Subjects treated for or have had a diagnosis of schizophrenia

•Subjects treated for or have had a diagnosis of bipolar disease within 3 years prior to screening

•Subjects with a history of generalized peripheral neuropathy

Endpoints (11)

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

Global cognition

Neuroimaging

Global cognition

1 endpoint

Secondary/protocol endpoint

Effects of BMS-241027 on cognitive performance using computerized cognitive tests

Time frame:Weeks 3, 6 and 9

descriptive

Neuroimaging

1 endpoint

Secondary/protocol endpoint

Effects of BMS-241027 on connectivity MRI

Time frame:Within the first 70 days after first dose

descriptive

Fluid / digital biomarkers

3 endpoints

Primary/protocol endpoint

Biomarker Measures: CSF levels of Tau N-terminal domain fragments

Time frame:Within the first 70 day after first dose

descriptive

Secondary/protocol endpoint

Effects of BMS-241027 on CSF levels of the mid-domain Tau fragment

Time frame:Within the first 70 days after first dose

descriptive

Secondary/protocol endpoint

Effects of BMS-241027 on CSF levels of neurofilaments

Time frame:Within the first 70 days after first dose

Neurofilament light (NfL)

descriptive

Safety / tolerability / PK

6 endpoints

Primary/protocol endpoint

Safety assessments: based on frequency of Serious Adverse Events (SAEs), frequency of Adverse events (AEs), discontinuation due to AEs and dose reduction

Time frame:Within the first 70 day after first dose

event count, event

Secondary/protocol endpoint

Maximal observed plasma concentration (Cmax) of BMS-241027 in subjects with mild Alzheimer's disease

Time frame:Weeks 1, 4, and 9

concentration, descriptive

Secondary/protocol endpoint

Observed plasma concentration at 24 hours post dose (C24) of BMS-241027 in subjects with mild Alzheimer's disease

Time frame:Weeks 1, 4, and 9

concentration, descriptive

Secondary/protocol endpoint

Time of maximal observed plasma concentration (Tmax) of BMS-241027 in subjects with mild Alzheimer's disease

Time frame:Weeks 1, 4, and 9

concentration, descriptive

Secondary/protocol endpoint

Area under the concentration-time curve in one dosing interval [AUC(TAU)] of BMS-241027 in subjects with mild Alzheimer's disease

Time frame:Weeks 1, 4, and 9

concentration, descriptive

Secondary/protocol endpoint

Safety assessments: based on vital sign measurements, ECGs and clinical laboratory tests

Time frame:Within the first 70 day after first dose

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.