A Phase II, Multicenter, Double Blind, Placebo-Controlled Safety, Tolerability Study of BMS-708163 in Patients With Mild to Moderate Alzheimer's Disease
This study has been completed.
Sponsor:
Bristol-Myers Squibb
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00810147
First received: December 16, 2008
Last updated: January 24, 2011
Last verified: June 2010
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Alzheimer's Disease |
Drug: BMS-708163 Drug: Placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, 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 |
Resource links provided by NLM:
Genetics Home Reference related topics:
Alzheimer disease
MedlinePlus related topics:
Alzheimer's Disease
U.S. FDA Resources
Further study details as provided by Bristol-Myers Squibb:
Primary Outcome Measures:
- 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) ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Pharmacodynamics effects of Cerebral Spinal Fluid [ Time Frame: Baseline, Week 12 and Week 24 ] [ Designated as safety issue: Yes ]
- Pharmacodynamics effects of the Alzheimer's Disease Assessment Scale - Cognitive Subscale [ Time Frame: Baseline, Week 12, Week 24 and Week 36 ] [ Designated as safety issue: Yes ]
- Pharmacodynamics effects of the Alzheimer's Disease Collaborative Study - Activities of Daily Living scale [ Time Frame: Baseline, Week 12, Week 24 and Week 36 ] [ Designated as safety issue: Yes ]
- 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 ] [ Designated as safety issue: Yes ]
- 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 ] [ Designated as safety issue: Yes ]
- Characterize Pharmacodynamics/Pharmacokinetics effects in refining the Pharmacokinetics/Pharmacodynamics model with Phase 2 data [ Time Frame: Baseline, Week 12 and Week 24 ] [ Designated as safety issue: Yes ]
- Characterize Pharmacodynamics/Pharmacokinetics effects by exploring correlations between exposure, biomarkers, and clinical effects [ Time Frame: Baseline, Week 12 and Week 24 ] [ Designated as safety issue: Yes ]
- Characterize Pharmacodynamics/Pharmacokinetics effects by exploring Pharmacokinetics variability, including the correlation between polymorphisms of CYP enzymes [ Time Frame: Baseline, Week 12 and Week 24 ] [ Designated as safety issue: Yes ]
| Enrollment: | 209 |
| Study Start Date: | February 2009 |
| Study Completion Date: | June 2010 |
| Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 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
|
Eligibility| Ages Eligible for Study: | 50 Years to 90 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00810147
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| 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 | |
| Denmark | |
| Local Institution | |
| Odense, Denmark, 5000 | |
| Finland | |
| Local Institution | |
| Kuopio, Finland, 70210 | |
| Local Institution | |
| Turku, Finland, 20520 | |
| Sweden | |
| Local Institution | |
| Malmo, Sweden, 212 24 | |
| Local Institution | |
| Molndal, Sweden, 431 41 | |
| Local Institution | |
| Stockholm, Sweden, 141 86 | |
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
| Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
More Information
Additional Information:
No publications provided by Bristol-Myers Squibb
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Study Director, Bristol-Myers Squibb |
| ClinicalTrials.gov Identifier: | NCT00810147 History of Changes |
| Other Study ID Numbers: | CN156-013, EUDRACT: 2008-005929-11 |
| Study First Received: | December 16, 2008 |
| Last Updated: | January 24, 2011 |
| Health Authority: | United States: Food and Drug Administration Denmark: Danish Medicines Agency Sweden: Medical Products Agency Finland: Finnish Medicines Agency |
Additional relevant MeSH terms:
|
Alzheimer Disease Dementia Brain Diseases Central Nervous System Diseases Nervous System Diseases |
Tauopathies Neurodegenerative Diseases Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders |
ClinicalTrials.gov processed this record on May 19, 2013