A Phase II, Multicenter, Double Blind, Placebo-Controlled Safety, Tolerability Study of BMS-708163 in Patients With Mild to Moderate Alzheimer's Disease

Alzheimer's Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00810147
• Other study ID #: CN156-013
• Secondary ID: EUDRACT: 2008-00
• Status: Completed
• Phase: Phase 2
• First received: December 16, 2008
• Last updated: September 23, 2015
• Start date: February 2009
• Est. completion date: June 2010

Study information

• Verified date: September 2015
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationDenmark: Danish Medicines AgencySweden: Medical Products AgencyFinland: Finnish Medicines Agency
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 209
• Est. completion date: June 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 90 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Intervention

Drug:
• BMS-708163
Capsules, Oral, 25 mg, once daily, 24 weeks
• BMS-708163
Capsules, Oral, 50 mg, once daily, 24 weeks
• BMS-708163
Capsules, Oral, 100 mg, once daily, 24 weeks
• BMS-708163
Capsules, Oral, 125 mg, once daily, 24 weeks
• Placebo
Capsules, Oral, 0 mg, once daily, 24 weeks

Locations

Country	Name	City	State
Denmark	Local Institution	Odense
Finland	Local Institution	Kuopio
Finland	Local Institution	Turku
Sweden	Local Institution	Malmo
Sweden	Local Institution	Molndal
Sweden	Local Institution	Stockholm
United States	University Of Alabama At Birmingham	Birmingham	Alabama
United States	Meridien Research	Brooksville	Florida
United States	The Ohio State University	Columbus	Ohio
United States	The University Of Texas	Dallas	Texas
United States	Brain Matters Research	Delray Beach	Florida
United States	Professional Neurological Associates, Pc	Dunmore	Pennsylvania
United States	R.I. Mood & Memory Research Institute	East Providence	Rhode Island
United States	Memory Enhancement Center Of Amercia, Inc.	Eatontown	New Jersey
United States	Margolin Brain Institute	Fresno	California
United States	Collaborative Neuroscience Network, Inc.	Garden Grove	California
United States	Md Clinical	Hallandale Beach	Florida
United States	Indiana University Medical Center	Indianapolis	Indiana
United States	The Clinical Trial Center Llc	Jenkintown	Pennsylvania
United States	Mary S. Easton Center	Los Angeles	California
United States	Pacific Institute For Medical Research, Inc.	Los Angeles	California
United States	Dean Foundation For Health Research & Education	Middleton	Wisconsin
United States	Yale University School Of Medicine	New Haven	Connecticut
United States	Columbia University	New York	New York
United States	Comprehensive Psychiatric Care	Norwich	Connecticut
United States	Compass Research, Llc	Orlando	Florida
United States	Four Rivers Clinical Research, Inc	Paducah	Kentucky
United States	21st Century Neurology	Phoenix	Arizona
United States	Banner Alzheimer'S Institute	Phoenix	Arizona
United States	Global Medical Institutes, Llc	Princeton	New Jersey
United States	Butler Hospital	Providence	Rhode Island
United States	Richard H. Weisler, Md, Pa & Associates	Raleigh	North Carolina
United States	University Of Rochester	Rochester	New York
United States	Pacific Research Network, Inc	San Diego	California
United States	California Neuroscience Research Medical Group, Inc.	Sherman Oaks	California
United States	Miami Research Associates	South Miami	Florida
United States	Sun Health Research Institue	Sun City	Arizona
United States	Usf Suncoast Alzheimer'S And Gerontology Center	Tampa	Florida
United States	Neurology & Neuroscience Center Of Ohio	Toledo	Ohio
United States	Tulsa Clinical Research, Llc	Tulsa	Oklahoma
United States	Center For Clinical Trials	Venice	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

United States,  Denmark,  Finland,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	Yes
Secondary	Pharmacodynamics effects of Cerebral Spinal Fluid		Baseline, Week 12 and Week 24	Yes
Secondary	Pharmacodynamics effects of the Alzheimer's Disease Assessment Scale - Cognitive Subscale		Baseline, Week 12, Week 24 and Week 36	Yes
Secondary	Pharmacodynamics effects of the Alzheimer's Disease Collaborative Study - Activities of Daily Living scale		Baseline, Week 12, Week 24 and Week 36	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	Characterize Pharmacodynamics/Pharmacokinetics effects in refining the Pharmacokinetics/Pharmacodynamics model with Phase 2 data		Baseline, Week 12 and Week 24	Yes
Secondary	Characterize Pharmacodynamics/Pharmacokinetics effects by exploring correlations between exposure, biomarkers, and clinical effects		Baseline, Week 12 and Week 24	Yes
Secondary	Characterize Pharmacodynamics/Pharmacokinetics effects by exploring Pharmacokinetics variability, including the correlation between polymorphisms of CYP enzymes		Baseline, Week 12 and Week 24	Yes

External Links

•   BMS Clinical Trials Disclosure
•   For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm
•   Investigator Inquiry form