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

Stopped early · 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 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.

Key facts

Study ID

NCT00890890

Run by

Bristol-Myers Squibb

People needed

263

Starts

2009-05-01

Expected to finish

2013-07-01

Last updated by the study team

2015-10-12

Who can join

Age: 45 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Pivotal Research Centers — Peoria, Arizona, 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. — Long Beach, California, United States
• Mary S. Easton Center — Los Angeles, California, United States
• Pharmacology Research Institute — Newport Beach, California, United States
• Uc Irvine Medical Center — Orange, California, United States
• Pacific Research Network — San Diego, California, United States
• Affiliated Research Institute — San Diego, California, United States
• University Of California, San Diego — San Diego, California, United States
• California Neuroscience Research Medical Group, Inc. — Sherman Oaks, California, United States
• Radiant Research, Inc. — Denver, Colorado, 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
• Indiana University Medical Center — Indianapolis, Indiana, United States
• Four Rivers Clinical Research, Inc — Paducah, Kentucky, United States
• Brigham & Women'S Hospital — Boston, Massachusetts, United States
• St Louis University — St Louis, Missouri, United States
• University Of Alabama At Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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