A Multicenter, Double Blind, Placebo-Controlled, Safety and Tolerability Study of BMS-708163 in Patients With Prodromal 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 Prodromal Alzheimer's Disease

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00890890
• Other study ID #: CN156-018
• Secondary ID: 2009-010067-16
• Status: Terminated
• Phase: Phase 2
• First received: April 29, 2009
• Last updated: September 23, 2015
• Start date: May 2009
• Est. completion date: July 2013

Study information

• Verified date: September 2015
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review BoardDenmark: Danish Medicines AgencyDenmark: Danish Dataprotection AgencyDenmark: The Danish National Committee on Biomedical Research EthicsSweden: Medical Products AgencySweden: The National Board of Health and WelfareSweden: Swedish Data Inspection BoardSweden: Swedish National Council on Medical EthicsFinland: Finnish Medicines AgencyFinland: Data Protection BoardFinland: National Advisory Board on Health Care EthicsCanada: Health CanadaFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)France: Institutional Ethical Committee
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine the safety and tolerability of BMS-708163 in patients with Prodromal Alzheimer's disease over a treatment period of a minimum of 104-weeks. In addition patients will be seen for safety visits at 4 and 12 weeks post treatment.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 263
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 45 Years to 90 Years

Eligibility

Inclusion Criteria:

• Patient meets clinical criteria for prodromal Alzheimer's disease (MMSE 24-30)

• Memory complaint by subject or study partner

• CSF aß42 levels < 200pg/mL or Total Tau/aß42 ratio of = 0.39

• Score of =4 on the Modified Hachinski Ischemia Scale

• CT results consistent with Alzheimer's disease

• Medically stable

• 6 years education

• Reliable study partner

• Must be able to swallow capsules

Exclusion Criteria:

• Premenopausal women

• DSM-IV diagnosis of Dementia 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

• 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:
• Avagacestat
Capsules, Oral, 50 mg, once daily, 104 - 220 Weeks
• Placebo
Capsules, Oral, 0 mg, once daily, 104 - 220 Weeks

Locations

Country	Name	City	State
Canada	Local Institution	Calgary	Alberta
Canada	Local Institution	Greenfield Park	Quebec
Canada	Local Institution	London	Ontario
Canada	Local Institution	Toronto	Ontario
Canada	Local Institution	Vancouver	British Columbia
Denmark	Local Institution	Copenhagen
Finland	Local Institution	Turku
France	Local Institution	Bordeaux Cedex
France	Local Institution	Dijon
France	Local Institution	Nantes
France	Local Institution	Rennes Cedex 9
France	Local Institution	Toulouse	Cedex 9
Sweden	Local Institution	Molndal
Sweden	Local Institution	Stockholm
United States	Senior Adults Specialty Research (Sasr)	Austin	Texas
United States	University Of Alabama At Birmingham	Birmingham	Alabama
United States	Brigham & Women'S Hospital	Boston	Massachusetts
United States	Spri Clinical Trials, Llc	Brooklyn	New York
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	Radiant Research, Inc.	Denver	Colorado
United States	Duke University Medical Center	Durham	North Carolina
United States	Memory Enhancement Center Of Amercia, Inc.	Eatontown	New Jersey
United States	Margolin Brain Institute	Fresno	California
United States	Md Clinical	Hallandale Beach	Florida
United States	Indiana University Medical Center	Indianapolis	Indiana
United States	Cleveland Clinic Lou Ruvo Center For Brain Health	Las Vegas	Nevada
United States	Collaborative Neuroscience Network, Inc.	Long Beach	California
United States	Mary S. Easton Center	Los Angeles	California
United States	Dean Foundation For Health Research & Education	Middleton	Wisconsin
United States	Mcw Clinics At Froedtert Hospital	Milwaukee	Wisconsin
United States	Robert Wood Johnson Medical School, Umdnj	New Brunswick	New Jersey
United States	Yale University School Of Medicine	New Haven	Connecticut
United States	Columbia University	New York	New York
United States	Nyu Langone Medical Center	New York	New York
United States	Pharmacology Research Institute	Newport Beach	California
United States	Comprehensive Psychiatric Care	Norwich	Connecticut
United States	Uc Irvine Medical Center	Orange	California
United States	Compass Research, Llc	Orlando	Florida
United States	Four Rivers Clinical Research, Inc	Paducah	Kentucky
United States	Pivotal Research Centers	Peoria	Arizona
United States	21st Century Neurology	Phoenix	Arizona
United States	Banner Alzheimer'S Institute	Phoenix	Arizona
United States	Oregon Health & Science University	Portland	Oregon
United States	Providence Cognitive Assessment Clinic	Portland	Oregon
United States	Global Medical Institutes, Llc	Princeton	New Jersey
United States	Butler Hospital	Providence	Rhode Island
United States	Raleigh Neurology Associates, Pa	Raleigh	North Carolina
United States	Richard H. Weisler, Md, Pa & Assoc.	Raleigh	North Carolina
United States	University Of Rochester Medical Center	Rochester	New York
United States	St Louis University	Saint Louis	Missouri
United States	Affiliated Research Institute	San Diego	California
United States	Pacific Research Network	San Diego	California
United States	University Of California, San Diego	San Diego	California
United States	California Neuroscience Research Medical Group, Inc.	Sherman Oaks	California
United States	Washington University School Of Medicine	St. Louis	Missouri
United States	Sun Health Research Institue	Sun City	Arizona
United States	Neurology & Neuroscience Center Of Ohio	Toledo	Ohio
United States	Memory Enhancement Center Of Nj, Inc.	Toms River	New Jersey
United States	Tulsa Clinical Research, Llc	Tulsa	Oklahoma
United States	Clinical Trials Of America, Inc.	Winston Salem	North Carolina
United States	Wake Forest University School Of Medicine	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

United States,  Canada,  Denmark,  Finland,  France,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and tolerability of BMS-708163 in patients with Prodromal Alzheimer's disease as measured by adverse events, vital signs, laboratory assessments, electrocardiograms (ECGs) and Safety Head Magnetic resonance imaging (MRI) findings		Every 12 weeks up to week 220	Yes
Primary	Safety and tolerability of BMS-708163 in patients with Prodromal Alzheimer's disease as measured by adverse events, vital signs, laboratory assessments, electrocardiograms (ECGs) and Safety Head Magnetic resonance imaging (MRI) findings		Avagacestat-treated patients will be seen for safety visits at 4 Post Treatment/Study Termination	Yes
Primary	Safety and tolerability of BMS-708163 in patients with Prodromal Alzheimer's disease as measured by adverse events, vital signs, laboratory assessments, electrocardiograms (ECGs) and Safety Head Magnetic resonance imaging (MRI) findings		Avagacestat-treated patients will be seen for safety visits at 12 Post Treatment/Study Termination	Yes
Primary	Safety and tolerability of BMS-708163 in patients with Prodromal Alzheimer's disease as measured by adverse events, vital signs, laboratory assessments, electrocardiograms (ECGs) and Safety Head Magnetic resonance imaging (MRI) findings		Avagacestat-treated patients will have a 24 week post treatment skin examination by a dermatologist	Yes
Secondary	Predictive value of Cerebral Spinal Fluid (CSF) biomarkers (Aß40, and Aß42, total Tau, total Tau/Aß42 ratio, phosphorylated Tau) on progression to dementia		Baseline (Week 0), Week 2 (optional), Week 24 and Week 104	No

External Links

•   BMS clinical trial educational resource
•   BMS Clinical Trial Information
•   For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm
•   Investigator Inquiry form