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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

This study has been completed.
Sponsor:
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00810147
First received: December 16, 2008
Last updated: January 24, 2011
Last verified: June 2010
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00810147

  Show 41 Study Locations
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
Brain Diseases
Central Nervous System Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Dementia
Mental Disorders
Nervous System Diseases
Neurodegenerative Diseases
Tauopathies

ClinicalTrials.gov processed this record on November 25, 2014