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

• Status: Terminated
• Trial end date: 2013-07-01
• 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 Prodromal Alzheimer's disease over a treatment period of a minimum of 104-weeks. In addition patients will be seen for safety visits at 4 and 12 weeks post treatment.

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

Details

• Lead Sponsor: Bristol-Myers Squibb

Criteria

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