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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00810147
Recruitment Status : Completed
First Posted : December 17, 2008
Last Update Posted : October 12, 2015
Information provided by (Responsible Party):
Bristol-Myers Squibb

Brief 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

Condition or disease Intervention/treatment Phase
Alzheimer's Disease Drug: BMS-708163 Drug: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 209 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Safety, Tolerability, Pharmacodynamic and Pharmacokinetic Effects of BMS-708163 in the Treatment of Patients With Mild to Moderate Alzheimer's Disease
Study Start Date : February 2009
Actual Primary Completion Date : June 2010
Actual Study Completion Date : June 2010

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: A1 Drug: BMS-708163
Capsules, Oral, 25 mg, once daily, 24 weeks

Active Comparator: A2 Drug: BMS-708163
Capsules, Oral, 50 mg, once daily, 24 weeks

Active Comparator: A3 Drug: BMS-708163
Capsules, Oral, 100 mg, once daily, 24 weeks

Active Comparator: A4 Drug: BMS-708163
Capsules, Oral, 125 mg, once daily, 24 weeks

Placebo Comparator: A5 Drug: Placebo
Capsules, Oral, 0 mg, once daily, 24 weeks

Primary Outcome Measures :
  1. Adverse Events [ Time Frame: Weekly for the first 12-weeks of the 24-Week dosing period (Baseline-Week-12) and every 2 weeks during the second 12-weeks of the 24-Week dosing period (Weeks 14-24) and during the subsequent 12-week washout period (Weeks 28, 32, & 36) ]

Secondary Outcome Measures :
  1. Pharmacodynamics effects of Cerebral Spinal Fluid [ Time Frame: Baseline, Week 12 and Week 24 ]
  2. Pharmacodynamics effects of the Alzheimer's Disease Assessment Scale - Cognitive Subscale [ Time Frame: Baseline, Week 12, Week 24 and Week 36 ]
  3. Pharmacodynamics effects of the Alzheimer's Disease Collaborative Study - Activities of Daily Living scale [ Time Frame: Baseline, Week 12, Week 24 and Week 36 ]
  4. Pharmacodynamics effects of the Global clinical impression as assessed with the Clinical Dementia Rating-Sum of Boxes [ Time Frame: Baseline, Week 12, Week 24 and Week 36 ]
  5. Characterize Pharmacodynamics/Pharmacokinetics effects of the plasma exposure of BMS-708163 and variability in a population with Alzheimer's disease [ Time Frame: Baseline, Week 12 and Week 24 ]
  6. Characterize Pharmacodynamics/Pharmacokinetics effects in refining the Pharmacokinetics/Pharmacodynamics model with Phase 2 data [ Time Frame: Baseline, Week 12 and Week 24 ]
  7. Characterize Pharmacodynamics/Pharmacokinetics effects by exploring correlations between exposure, biomarkers, and clinical effects [ Time Frame: Baseline, Week 12 and Week 24 ]
  8. Characterize Pharmacodynamics/Pharmacokinetics effects by exploring Pharmacokinetics variability, including the correlation between polymorphisms of CYP enzymes [ Time Frame: Baseline, Week 12 and Week 24 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00810147

  Hide Study Locations
United States, Alabama
University Of Alabama At Birmingham
Birmingham, Alabama, United States, 35294
United States, Arizona
21st Century Neurology
Phoenix, Arizona, United States, 85004
Banner Alzheimer'S Institute
Phoenix, Arizona, United States, 85006
Sun Health Research Institue
Sun City, Arizona, United States, 85351
United States, California
Margolin Brain Institute
Fresno, California, United States, 93720
Collaborative Neuroscience Network, Inc.
Garden Grove, California, United States, 92845
Pacific Institute For Medical Research, Inc.
Los Angeles, California, United States, 90024
Mary S. Easton Center
Los Angeles, California, United States, 90095
Pacific Research Network, Inc
San Diego, California, United States, 92103
California Neuroscience Research Medical Group, Inc.
Sherman Oaks, California, United States, 91403
United States, Connecticut
Yale University School Of Medicine
New Haven, Connecticut, United States, 06510
Comprehensive Psychiatric Care
Norwich, Connecticut, United States, 06360
United States, Florida
Meridien Research
Brooksville, Florida, United States, 34601
Brain Matters Research
Delray Beach, Florida, United States, 33445
Md Clinical
Hallandale Beach, Florida, United States, 33009
Compass Research, Llc
Orlando, Florida, United States, 32806
Miami Research Associates
South Miami, Florida, United States, 33143
Usf Suncoast Alzheimer'S And Gerontology Center
Tampa, Florida, United States, 33613
Center For Clinical Trials
Venice, Florida, United States, 34285
United States, Indiana
Indiana University Medical Center
Indianapolis, Indiana, United States, 46202
United States, Kentucky
Four Rivers Clinical Research, Inc
Paducah, Kentucky, United States, 42003
United States, New Jersey
Memory Enhancement Center Of Amercia, Inc.
Eatontown, New Jersey, United States, 07724
Global Medical Institutes, Llc
Princeton, New Jersey, United States, 08540
United States, New York
Columbia University
New York, New York, United States, 10032
University Of Rochester
Rochester, New York, United States, 14620
United States, North Carolina
Richard H. Weisler, Md, Pa & Associates
Raleigh, North Carolina, United States, 27609
United States, Ohio
The Ohio State University
Columbus, Ohio, United States, 43210
Neurology & Neuroscience Center Of Ohio
Toledo, Ohio, United States, 43623
United States, Oklahoma
Tulsa Clinical Research, Llc
Tulsa, Oklahoma, United States, 74104
United States, Pennsylvania
Professional Neurological Associates, Pc
Dunmore, Pennsylvania, United States, 18512
The Clinical Trial Center Llc
Jenkintown, Pennsylvania, United States, 19046
United States, Rhode Island
R.I. Mood & Memory Research Institute
East Providence, Rhode Island, United States, 02914
Butler Hospital
Providence, Rhode Island, United States, 02906
United States, Texas
The University Of Texas
Dallas, Texas, United States, 75390
United States, Wisconsin
Dean Foundation For Health Research & Education
Middleton, Wisconsin, United States, 53562
Local Institution
Odense, Denmark, 5000
Local Institution
Kuopio, Finland, 70210
Local Institution
Turku, Finland, 20520
Local Institution
Malmo, Sweden, 212 24
Local Institution
Molndal, Sweden, 431 41
Local Institution
Stockholm, Sweden, 141 86
Sponsors and Collaborators
Bristol-Myers Squibb
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Bristol-Myers Squibb Identifier: NCT00810147     History of Changes
Other Study ID Numbers: CN156-013
EUDRACT: 2008-005929-11
First Posted: December 17, 2008    Key Record Dates
Last Update Posted: October 12, 2015
Last Verified: September 2015

Additional relevant MeSH terms:
Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders