TerminatedPhase 2

A Multicenter, Double Blind, Placebo-Controlled, Safety and Tolerability Study of BMS-708163 in Patients With Prodromal Alzheimer's Disease

Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Safety, Tolerability, Pharmacodynamic and Pharmacokinetic Effects of BMS-708163 in the Treatment of Patients With Prodromal Alzheimer's Disease

Lead sponsor

Bristol-Myers Squibb

Asset

Avagacestat

Listed sites

Recruiting sites

Enrollment

263

actual

Study population

Alzheimer’s disease

Key I/E criteria

•prodromal AD•MMSE 24-30•Study partner/caregiver required

Primary endpoint

•Safety and tolerability of BMS-708163

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 number2009-010067-16

Org study IDCN156-018

NCT IDNCT00890890

Timeline

Milestones

Study first posted2009-04-30estimated

Study start2009-05 (month precision)

Primary completion2013-07actual (month precision)

Study completion2013-07actual (month precision)

Last update posted2015-10-12estimated

Assets

Drug assets

Avagacestat

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age45 Years

Maximum age90 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Patient meets clinical criteria for prodromal Alzheimer's disease (MMSE 24-30)

•Memory complaint by subject or study partner

•CSF aβ42 levels < 200pg/mL or Total Tau/aβ42 ratio of ≥ 0.39

•Score of ≤4 on the Modified Hachinski Ischemia Scale

•CT results consistent with Alzheimer's disease

•Medically stable

•6 years education

•Reliable study partner

•Must be able to swallow capsules

Exclusion criteria

•Premenopausal women

•DSM-IV diagnosis of Dementia History of stroke

•Immunocompromised

•Active peptic ulcer, GI bleed, chronic inflammatory bowel disease, chronic diarrhea or past GI surgery that would impact drug absorption

•Unstable Vitamin B-12 deficiency

•Hematologic or solid malignancy within 5 years

•Geriatric Depression Scale ≥ 6

•Unstable medical condition

•Alcohol or drug abuse history with 12-months of study entry

•Significant drug allergy

•Prisoners, compulsory psychiatric patients, or residents of nursing home or skilled nursing facility at entry

•Any other experimental therapy with 30-days of study entry

Endpoints (5)

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

Neuroimaging

Disease progression

1 endpoint

Secondary/protocol endpoint

Predictive value of Cerebral Spinal Fluid (CSF) biomarkers (Aβ40, and Aβ42, total Tau, total Tau/Aβ42 ratio, phosphorylated Tau) on progression to dementia

Time frame:Baseline (Week 0), Week 2 (optional), Week 24 and Week 104

ratio, descriptive

Neuroimaging

4 endpoints

Primary/protocol endpoint

Safety and tolerability of BMS-708163 in patients with Prodromal Alzheimer's disease as measured by adverse events, vital signs, laboratory assessments, electrocardiograms (ECGs) and Safety Head Magnetic resonance imaging (MRI) findings

Time frame:Every 12 weeks up to week 220

event count, event

Primary/protocol endpoint

Time frame:Avagacestat-treated patients will be seen for safety visits at 4 Post Treatment/Study Termination

event count, event

Primary/protocol endpoint

Time frame:Avagacestat-treated patients will be seen for safety visits at 12 Post Treatment/Study Termination

event count, event

Primary/protocol endpoint

Time frame:Avagacestat-treated patients will have a 24 week post treatment skin examination by a dermatologist

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

Coric V, Salloway S, van Dyck CH, Dubois B, Andreasen N, Brody M, Curtis C, Soininen H, Thein S, Shiovitz T, Pilcher G, Ferris S, Colby S, Kerselaers W, Dockens R, Soares H, Kaplita S, Luo F, Pachai C, Bracoud L, Mintun M, Grill JD, Marek K, Seibyl J, Cedarbaum JM, Albright C, Feldman HH, Berman RM. Targeting Prodromal Alzheimer Disease With Avagacestat: A Randomized Clinical Trial. JAMA Neurol. 2015 Nov;72(11):1324-33. doi: 10.1001/jamaneurol.2015.0607.
PMID26414022via 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.