Back to resultsA Phase II, Multicenter, Double Blind, Placebo-Controlled Safety, Tolerability Study of BMS-708163 in Patients With Mild to Moderate Alzheimer's Disease
Primary Purpose
Alzheimer's Disease
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
BMS-708163
BMS-708163
BMS-708163
BMS-708163
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Alzheimer's Disease
Eligibility 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
Sites / Locations
- University Of Alabama At Birmingham
- 21st Century Neurology
- Banner Alzheimer'S Institute
- Sun Health Research Institue
- Margolin Brain Institute
- Collaborative Neuroscience Network, Inc.
- Pacific Institute For Medical Research, Inc.
- Mary S. Easton Center
- Pacific Research Network, Inc
- California Neuroscience Research Medical Group, Inc.
- Yale University School Of Medicine
- Comprehensive Psychiatric Care
- Meridien Research
- Brain Matters Research
- Md Clinical
- Compass Research, Llc
- Miami Research Associates
- Usf Suncoast Alzheimer'S And Gerontology Center
- Center For Clinical Trials
- Indiana University Medical Center
- Four Rivers Clinical Research, Inc
- Memory Enhancement Center Of Amercia, Inc.
- Global Medical Institutes, Llc
- Columbia University
- University Of Rochester
- Richard H. Weisler, Md, Pa & Associates
- The Ohio State University
- Neurology & Neuroscience Center Of Ohio
- Tulsa Clinical Research, Llc
- Professional Neurological Associates, Pc
- The Clinical Trial Center Llc
- R.I. Mood & Memory Research Institute
- Butler Hospital
- The University Of Texas
- Dean Foundation For Health Research & Education
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Placebo Comparator
Arm Label
A1
A2
A3
A4
A5
Arm Description
Outcomes
Primary Outcome Measures
Adverse Events
Secondary Outcome Measures
Pharmacodynamics effects of Cerebral Spinal Fluid
Pharmacodynamics effects of the Alzheimer's Disease Assessment Scale - Cognitive Subscale
Pharmacodynamics effects of the Alzheimer's Disease Collaborative Study - Activities of Daily Living scale
Pharmacodynamics effects of the Global clinical impression as assessed with the Clinical Dementia Rating-Sum of Boxes
Characterize Pharmacodynamics/Pharmacokinetics effects of the plasma exposure of BMS-708163 and variability in a population with Alzheimer's disease
Characterize Pharmacodynamics/Pharmacokinetics effects in refining the Pharmacokinetics/Pharmacodynamics model with Phase 2 data
Characterize Pharmacodynamics/Pharmacokinetics effects by exploring correlations between exposure, biomarkers, and clinical effects
Characterize Pharmacodynamics/Pharmacokinetics effects by exploring Pharmacokinetics variability, including the correlation between polymorphisms of CYP enzymes
Full Information
NCT ID
NCT00810147
First Posted
December 16, 2008
Last Updated
September 23, 2015
Sponsor
Bristol-Myers Squibb
1. Study Identification
Unique Protocol Identification Number
NCT00810147
Brief Title
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
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 Type
Interventional
2. Study Status
Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
February 2009 (undefined)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
June 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bristol-Myers Squibb
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
209 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A1
Arm Type
Active Comparator
Arm Title
A2
Arm Type
Active Comparator
Arm Title
A3
Arm Type
Active Comparator
Arm Title
A4
Arm Type
Active Comparator
Arm Title
A5
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
BMS-708163
Intervention Description
Capsules, Oral, 25 mg, once daily, 24 weeks
Intervention Type
Drug
Intervention Name(s)
BMS-708163
Intervention Description
Capsules, Oral, 50 mg, once daily, 24 weeks
Intervention Type
Drug
Intervention Name(s)
BMS-708163
Intervention Description
Capsules, Oral, 100 mg, once daily, 24 weeks
Intervention Type
Drug
Intervention Name(s)
BMS-708163
Intervention Description
Capsules, Oral, 125 mg, once daily, 24 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Capsules, Oral, 0 mg, once daily, 24 weeks
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Pharmacodynamics effects of Cerebral Spinal Fluid
Time Frame
Baseline, Week 12 and Week 24
Title
Pharmacodynamics effects of the Alzheimer's Disease Assessment Scale - Cognitive Subscale
Time Frame
Baseline, Week 12, Week 24 and Week 36
Title
Pharmacodynamics effects of the Alzheimer's Disease Collaborative Study - Activities of Daily Living scale
Time Frame
Baseline, Week 12, Week 24 and Week 36
Title
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
Title
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
Title
Characterize Pharmacodynamics/Pharmacokinetics effects in refining the Pharmacokinetics/Pharmacodynamics model with Phase 2 data
Time Frame
Baseline, Week 12 and Week 24
Title
Characterize Pharmacodynamics/Pharmacokinetics effects by exploring correlations between exposure, biomarkers, and clinical effects
Time Frame
Baseline, Week 12 and Week 24
Title
Characterize Pharmacodynamics/Pharmacokinetics effects by exploring Pharmacokinetics variability, including the correlation between polymorphisms of CYP enzymes
Time Frame
Baseline, Week 12 and Week 24
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
University Of Alabama At Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
21st Century Neurology
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85004
Country
United States
Facility Name
Banner Alzheimer'S Institute
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85006
Country
United States
Facility Name
Sun Health Research Institue
City
Sun City
State/Province
Arizona
ZIP/Postal Code
85351
Country
United States
Facility Name
Margolin Brain Institute
City
Fresno
State/Province
California
ZIP/Postal Code
93720
Country
United States
Facility Name
Collaborative Neuroscience Network, Inc.
City
Garden Grove
State/Province
California
ZIP/Postal Code
92845
Country
United States
Facility Name
Pacific Institute For Medical Research, Inc.
City
Los Angeles
State/Province
California
ZIP/Postal Code
90024
Country
United States
Facility Name
Mary S. Easton Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Pacific Research Network, Inc
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
California Neuroscience Research Medical Group, Inc.
City
Sherman Oaks
State/Province
California
ZIP/Postal Code
91403
Country
United States
Facility Name
Yale University School Of Medicine
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Facility Name
Comprehensive Psychiatric Care
City
Norwich
State/Province
Connecticut
ZIP/Postal Code
06360
Country
United States
Facility Name
Meridien Research
City
Brooksville
State/Province
Florida
ZIP/Postal Code
34601
Country
United States
Facility Name
Brain Matters Research
City
Delray Beach
State/Province
Florida
ZIP/Postal Code
33445
Country
United States
Facility Name
Md Clinical
City
Hallandale Beach
State/Province
Florida
ZIP/Postal Code
33009
Country
United States
Facility Name
Compass Research, Llc
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Miami Research Associates
City
South Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
Facility Name
Usf Suncoast Alzheimer'S And Gerontology Center
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
Country
United States
Facility Name
Center For Clinical Trials
City
Venice
State/Province
Florida
ZIP/Postal Code
34285
Country
United States
Facility Name
Indiana University Medical Center
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Four Rivers Clinical Research, Inc
City
Paducah
State/Province
Kentucky
ZIP/Postal Code
42003
Country
United States
Facility Name
Memory Enhancement Center Of Amercia, Inc.
City
Eatontown
State/Province
New Jersey
ZIP/Postal Code
07724
Country
United States
Facility Name
Global Medical Institutes, Llc
City
Princeton
State/Province
New Jersey
ZIP/Postal Code
08540
Country
United States
Facility Name
Columbia University
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
University Of Rochester
City
Rochester
State/Province
New York
ZIP/Postal Code
14620
Country
United States
Facility Name
Richard H. Weisler, Md, Pa & Associates
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27609
Country
United States
Facility Name
The Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Neurology & Neuroscience Center Of Ohio
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43623
Country
United States
Facility Name
Tulsa Clinical Research, Llc
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74104
Country
United States
Facility Name
Professional Neurological Associates, Pc
City
Dunmore
State/Province
Pennsylvania
ZIP/Postal Code
18512
Country
United States
Facility Name
The Clinical Trial Center Llc
City
Jenkintown
State/Province
Pennsylvania
ZIP/Postal Code
19046
Country
United States
Facility Name
R.I. Mood & Memory Research Institute
City
East Providence
State/Province
Rhode Island
ZIP/Postal Code
02914
Country
United States
Facility Name
Butler Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02906
Country
United States
Facility Name
The University Of Texas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
Dean Foundation For Health Research & Education
City
Middleton
State/Province
Wisconsin
ZIP/Postal Code
53562
Country
United States
Facility Name
Local Institution
City
Odense
ZIP/Postal Code
5000
Country
Denmark
Facility Name
Local Institution
City
Kuopio
ZIP/Postal Code
70210
Country
Finland
Facility Name
Local Institution
City
Turku
ZIP/Postal Code
20520
Country
Finland
Facility Name
Local Institution
City
Malmo
ZIP/Postal Code
212 24
Country
Sweden
Facility Name
Local Institution
City
Molndal
ZIP/Postal Code
431 41
Country
Sweden
Facility Name
Local Institution
City
Stockholm
ZIP/Postal Code
141 86
Country
Sweden
12. IPD Sharing Statement
Citations:
PubMed Identifier
22892585
Citation
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 gamma-secretase inhibitor avagacestat in a phase 2 study of mild to moderate Alzheimer disease. Arch Neurol. 2012 Nov;69(11):1430-40. doi: 10.1001/archneurol.2012.2194.
Results Reference
derived
Learn more about this trial
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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