A Phase II, Multicenter, Double Blind, Placebo-Controlled Safety, Tolerability Study of BMS-708163 in Patients With Mild to Moderate Alzheimer's Disease
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
2 other identifiers
interventional
209
4 countries
41
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Feb 2009
Shorter than P25 for phase_2
41 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 16, 2008
CompletedFirst Posted
Study publicly available on registry
December 17, 2008
CompletedStudy Start
First participant enrolled
February 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2010
CompletedOctober 12, 2015
September 1, 2015
1.3 years
December 16, 2008
September 23, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Adverse Events
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 Outcomes (8)
Pharmacodynamics effects of Cerebral Spinal Fluid
Baseline, Week 12 and Week 24
Pharmacodynamics effects of the Alzheimer's Disease Assessment Scale - Cognitive Subscale
Baseline, Week 12, Week 24 and Week 36
Pharmacodynamics effects of the Alzheimer's Disease Collaborative Study - Activities of Daily Living scale
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
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
Baseline, Week 12 and Week 24
- +3 more secondary outcomes
Study Arms (5)
A1
ACTIVE COMPARATORA2
ACTIVE COMPARATORA3
ACTIVE COMPARATORA4
ACTIVE COMPARATORA5
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Clinical diagnosis of Mild to Moderate Alzheimer's disease (MMSE 16-26)
- 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
- years education
- Reliable study partner (caregiver)
- Must be able to swallow capsules
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (41)
University Of Alabama At Birmingham
Birmingham, Alabama, 35294, United States
21st Century Neurology
Phoenix, Arizona, 85004, United States
Banner Alzheimer'S Institute
Phoenix, Arizona, 85006, United States
Sun Health Research Institue
Sun City, Arizona, 85351, United States
Margolin Brain Institute
Fresno, California, 93720, United States
Collaborative Neuroscience Network, Inc.
Garden Grove, California, 92845, United States
Pacific Institute For Medical Research, Inc.
Los Angeles, California, 90024, United States
Mary S. Easton Center
Los Angeles, California, 90095, United States
Pacific Research Network, Inc
San Diego, California, 92103, United States
California Neuroscience Research Medical Group, Inc.
Sherman Oaks, California, 91403, United States
Yale University School Of Medicine
New Haven, Connecticut, 06510, United States
Comprehensive Psychiatric Care
Norwich, Connecticut, 06360, United States
Meridien Research
Brooksville, Florida, 34601, United States
Brain Matters Research
Delray Beach, Florida, 33445, United States
Md Clinical
Hallandale, Florida, 33009, United States
Compass Research, Llc
Orlando, Florida, 32806, United States
Miami Research Associates
South Miami, Florida, 33143, United States
Usf Suncoast Alzheimer'S And Gerontology Center
Tampa, Florida, 33613, United States
Center For Clinical Trials
Venice, Florida, 34285, United States
Indiana University Medical Center
Indianapolis, Indiana, 46202, United States
Four Rivers Clinical Research, Inc
Paducah, Kentucky, 42003, United States
Memory Enhancement Center Of Amercia, Inc.
Eatontown, New Jersey, 07724, United States
Global Medical Institutes, Llc
Princeton, New Jersey, 08540, United States
Columbia University
New York, New York, 10032, United States
University Of Rochester
Rochester, New York, 14620, United States
Richard H. Weisler, Md, Pa & Associates
Raleigh, North Carolina, 27609, United States
The Ohio State University
Columbus, Ohio, 43210, United States
Neurology & Neuroscience Center Of Ohio
Toledo, Ohio, 43623, United States
Tulsa Clinical Research, Llc
Tulsa, Oklahoma, 74104, United States
Professional Neurological Associates, Pc
Dunmore, Pennsylvania, 18512, United States
The Clinical Trial Center Llc
Jenkintown, Pennsylvania, 19046, United States
R.I. Mood & Memory Research Institute
East Providence, Rhode Island, 02914, United States
Butler Hospital
Providence, Rhode Island, 02906, United States
The University Of Texas
Dallas, Texas, 75390, United States
Dean Foundation For Health Research & Education
Middleton, Wisconsin, 53562, United States
Local Institution
Odense, 5000, Denmark
Local Institution
Kuopio, 70210, Finland
Local Institution
Turku, 20520, Finland
Local Institution
Malmo, 212 24, Sweden
Local Institution
Mölndal, 431 41, Sweden
Local Institution
Stockholm, 141 86, Sweden
Related Publications (1)
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.
PMID: 22892585DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 16, 2008
First Posted
December 17, 2008
Study Start
February 1, 2009
Primary Completion
June 1, 2010
Study Completion
June 1, 2010
Last Updated
October 12, 2015
Record last verified: 2015-09