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

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 2

Conditions: Alzheimer's Disease

Treatments: Drug: BMS-708163; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00810147

EUDRACT: 2008-005929-11

CN156-013

Details and patient eligibility

About

The purpose of this study is to determine the safety and tolerability of BMS-708163 in patients with mild to moderate Alzheimer's disease over a treatment period of 12-weeks and the course of any potential effects during a 12-week wash-out period

Enrollment: 209 patients

Sex: All

Ages: 50 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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209 participants in 5 patient groups, including a placebo group

A1

Active Comparator group

Treatment:

Drug: BMS-708163

Drug: BMS-708163

Drug: BMS-708163

Drug: BMS-708163

A2

Active Comparator group

Treatment:

Drug: BMS-708163

Drug: BMS-708163

Drug: BMS-708163

Drug: BMS-708163

A3

Active Comparator group

Treatment:

Drug: BMS-708163

Drug: BMS-708163

Drug: BMS-708163

Drug: BMS-708163

A4

Active Comparator group

Treatment:

Drug: BMS-708163

Drug: BMS-708163

Drug: BMS-708163

Drug: BMS-708163

A5

Placebo Comparator group

Treatment:

Drug: Placebo