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

• Status: Completed
• Trial end date: 2010-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bristol-Myers Squibb

Criteria

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