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

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

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