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

Completed · Phase 2 · Has a placebo group

Conditions studied: Alzheimer's Disease

In brief

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

Key facts

Study ID

NCT00810147

Run by

Bristol-Myers Squibb

People needed

209

Starts

2009-02-01

Expected to finish

2010-06-01

Last updated by the study team

2015-10-12

Who can join

Age: 50 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University Of Alabama At Birmingham — Birmingham, Alabama, United States
• 21st Century Neurology — Phoenix, Arizona, United States
• Banner Alzheimer'S Institute — Phoenix, Arizona, United States
• Sun Health Research Institue — Sun City, Arizona, United States
• Margolin Brain Institute — Fresno, California, United States
• Collaborative Neuroscience Network, Inc. — Garden Grove, California, United States
• Pacific Institute For Medical Research, Inc. — Los Angeles, California, United States
• Mary S. Easton Center — Los Angeles, California, United States
• Pacific Research Network, Inc — San Diego, California, United States
• California Neuroscience Research Medical Group, Inc. — Sherman Oaks, California, United States
• Yale University School Of Medicine — New Haven, Connecticut, United States
• Comprehensive Psychiatric Care — Norwich, Connecticut, United States
• Meridien Research — Brooksville, Florida, United States
• Brain Matters Research — Delray Beach, Florida, United States
• Md Clinical — Hallandale, Florida, United States
• Compass Research, Llc — Orlando, Florida, United States
• Miami Research Associates — South Miami, Florida, United States
• Usf Suncoast Alzheimer'S And Gerontology Center — Tampa, Florida, United States
• Center For Clinical Trials — Venice, Florida, United States
• Indiana University Medical Center — Indianapolis, Indiana, United States
• Four Rivers Clinical Research, Inc — Paducah, Kentucky, United States
• Memory Enhancement Center Of Amercia, Inc. — Eatontown, New Jersey, United States
• Global Medical Institutes, Llc — Princeton, New Jersey, United States
• Columbia University — New York, New York, United States
• University Of Rochester — Rochester, New York, United States

Full record on ClinicalTrials.gov

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