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Trial record 1 of 1 for:    NCT00810147
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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

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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

Tracking Information
First Submitted Date  ICMJE December 16, 2008
First Posted Date  ICMJE December 17, 2008
Last Update Posted Date October 12, 2015
Study Start Date  ICMJE February 2009
Actual Primary Completion Date June 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 30, 2009)
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) ]
Original Primary Outcome Measures  ICMJE
 (submitted: December 16, 2008)
Adverse Events [ Time Frame: Weekly for the 12-Week dosing period (Baseline-Week-12) and every 4 weeks during the 12-Week washout period (Weeks 16, 20, & 24) ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 30, 2009)
  • Pharmacodynamics effects of Cerebral Spinal Fluid [ Time Frame: Baseline, Week 12 and Week 24 ]
  • Pharmacodynamics effects of the Alzheimer's Disease Assessment Scale - Cognitive Subscale [ Time Frame: Baseline, Week 12, Week 24 and Week 36 ]
  • Pharmacodynamics effects of the Alzheimer's Disease Collaborative Study - Activities of Daily Living scale [ Time Frame: Baseline, Week 12, Week 24 and Week 36 ]
  • 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 ]
  • 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 ]
  • Characterize Pharmacodynamics/Pharmacokinetics effects in refining the Pharmacokinetics/Pharmacodynamics model with Phase 2 data [ Time Frame: Baseline, Week 12 and Week 24 ]
  • Characterize Pharmacodynamics/Pharmacokinetics effects by exploring correlations between exposure, biomarkers, and clinical effects [ Time Frame: Baseline, Week 12 and Week 24 ]
  • Characterize Pharmacodynamics/Pharmacokinetics effects by exploring Pharmacokinetics variability, including the correlation between polymorphisms of CYP enzymes [ Time Frame: Baseline, Week 12 and Week 24 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: December 16, 2008)
  • Pharmacodynamics effects of Cerebral Spinal Fluid [ Time Frame: Baseline, Week 12 and Week 24 ]
  • Pharmacodynamics effects of the Alzheimer's Disease Assessment Scale - Cognitive Subscale [ Time Frame: Baseline, Week 12 and Week 24 ]
  • Pharmacodynamics effects of the Alzheimer's Disease Collaborative Study - Activities of Daily Living scale [ Time Frame: Baseline, Week 12 and Week 24 ]
  • Pharmacodynamics effects of the Global clinical impression as assessed with the Clinical Dementia Rating-Sum of Boxes [ Time Frame: Baseline, Week 12 and Week 24 ]
  • 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 ]
  • Characterize Pharmacodynamics/Pharmacokinetics effects in refining the Pharmacokinetics/Pharmacodynamics model with Phase 2 data [ Time Frame: Baseline, Week 12 and Week 24 ]
  • Characterize Pharmacodynamics/Pharmacokinetics effects by exploring correlations between exposure, biomarkers, and clinical effects [ Time Frame: Baseline, Week 12 and Week 24 ]
  • Characterize Pharmacodynamics/Pharmacokinetics effects by exploring Pharmacokinetics variability, including the correlation between polymorphisms of CYP enzymes [ Time Frame: Baseline, Week 12 and Week 24 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Phase II, Multicenter, Double Blind, Placebo-Controlled Safety, Tolerability Study of BMS-708163 in Patients With Mild to Moderate Alzheimer's Disease
Official Title  ICMJE 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
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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Alzheimer's Disease
Intervention  ICMJE
  • Drug: BMS-708163
    Capsules, Oral, 25 mg, once daily, 24 weeks
  • Drug: BMS-708163
    Capsules, Oral, 50 mg, once daily, 24 weeks
  • Drug: BMS-708163
    Capsules, Oral, 100 mg, once daily, 24 weeks
  • Drug: BMS-708163
    Capsules, Oral, 125 mg, once daily, 24 weeks
  • Drug: Placebo
    Capsules, Oral, 0 mg, once daily, 24 weeks
Study Arms  ICMJE
  • Active Comparator: A1
    Intervention: Drug: BMS-708163
  • Active Comparator: A2
    Intervention: Drug: BMS-708163
  • Active Comparator: A3
    Intervention: Drug: BMS-708163
  • Active Comparator: A4
    Intervention: Drug: BMS-708163
  • Placebo Comparator: A5
    Intervention: Drug: Placebo
Publications * Coric V, van Dyck CH, Salloway S, Andreasen N, Brody M, Richter RW, Soininen H, Thein S, Shiovitz T, Pilcher G, Colby S, Rollin L, Dockens R, Pachai C, Portelius E, Andreasson U, Blennow K, Soares H, Albright C, Feldman HH, Berman RM. Safety and tolerability of the γ-secretase inhibitor avagacestat in a phase 2 study of mild to moderate Alzheimer disease. Arch Neurol. 2012 Nov;69(11):1430-40.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 14, 2010)
209
Original Estimated Enrollment  ICMJE
 (submitted: December 16, 2008)
200
Actual Study Completion Date  ICMJE June 2010
Actual Primary Completion Date June 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark,   Finland,   Sweden,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00810147
Other Study ID Numbers  ICMJE CN156-013
EUDRACT: 2008-005929-11
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bristol-Myers Squibb
Study Sponsor  ICMJE Bristol-Myers Squibb
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
PRS Account Bristol-Myers Squibb
Verification Date September 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP