CompletedPhase 2

A Phase II, Multicenter, Double Blind, Placebo-Controlled Safety, Tolerability Study of BMS-708163 in Patients With Mild to Moderate 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 Mild to Moderate Alzheimer's Disease

Lead sponsor

Bristol-Myers Squibb

Asset

Avagacestat

Listed sites

Recruiting sites

Enrollment

209

actual

Study population

Alzheimer’s disease

Key I/E criteria

•mild-to-moderate AD•MMSE 16-26•Study partner/caregiver required

Primary endpoint

•Adverse Events

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

Org study IDCN156-013

SecondaryEUDRACT: 2008-005929-11

NCT IDNCT00810147

Timeline

Milestones

Study first posted2008-12-17estimated

Study start2009-02 (month precision)

Primary completion2010-06actual (month precision)

Study completion2010-06actual (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 age50 Years

Maximum age90 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Clinical diagnosis of Mild to Moderate Alzheimer's disease (MMSE 16-26)

•6 Month cognitive decline

•Stable marketed AD therapy x2 months or additional marketed AD therapy during study

•Score of <=4 on the Modified Hachinski Ischemia Scale

•CT results consistent with Alzheimer's disease

•Medically stable

•6 years education

•Reliable study partner (caregiver)

•Must be able to swallow capsules

Exclusion criteria

•Premenopausal women

•Dementia due to other causes than Alzheimer's disease

•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

•Alzheimer's disease modification experimental therapy with 12 months of study entry

•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 (9)

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

Other (unclassified)

Global cognition

Function / daily living

Global cognition

1 endpoint

Secondary/protocol endpoint

Pharmacodynamics effects of the Global clinical impression as assessed with the Clinical Dementia Rating-Sum of Boxes

Time frame:Baseline, Week 12, Week 24 and Week 36

Clinical Dementia Rating-Sum of Boxes (CDR-SB)

descriptive

Function / daily living

1 endpoint

Secondary/protocol endpoint

Pharmacodynamics effects of the Alzheimer's Disease Collaborative Study - Activities of Daily Living scale

Time frame:Baseline, Week 12, Week 24 and Week 36

descriptive

Safety / tolerability / PK

5 endpoints

Primary/protocol endpoint

Adverse Events

Time frame:Weekly for the first 12-weeks of the 24-Week dosing period (Baseline-Week-12) and every 2 weeks during the second 12-weeks of the 24-Week dosing period (Weeks 14-24) and during the subsequent 12-week washout period (Weeks 28, 32, & 36)

event count, event

Secondary/protocol endpoint

Characterize Pharmacodynamics/Pharmacokinetics effects of the plasma exposure of BMS-708163 and variability in a population with Alzheimer's disease