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

Bristol-Myers Squibb (BMS)

Status and phase

Terminated

Phase 2

Conditions

Alzheimer's Disease

Treatments

Drug: Avagacestat

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT00890890

2009-010067-16 (EudraCT Number)

CN156-018

Details and patient eligibility

About

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.

Enrollment

263 patients

Sex

All

Ages

45 to 90 years old

Volunteers

No Healthy Volunteers

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