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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.
 
ClinicalTrials.gov Identifier: NCT00810147
Recruitment Status : Completed
First Posted : December 17, 2008
Last Update Posted : October 12, 2015
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Study Description
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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 Design
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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


Arms and Interventions
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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


Outcome Measures
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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 ]

Eligibility Criteria
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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
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
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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 ClinicalTrials.gov identifier (NCT number): NCT00810147


Locations
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Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00810147    
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:
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Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
 Neurocognitive Disorders
Mental Disorders
BMS 708163
Gamma Secretase Inhibitors and Modulators
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action