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

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00890890
First received: April 29, 2009
Last updated: September 4, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention Phase
Alzheimer's Disease
Drug: Avagacestat
Drug: Placebo
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • 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 [ Time Frame: Every 12 weeks up to week 220 ] [ Designated as safety issue: Yes ]
  • 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 [ Time Frame: Avagacestat-treated patients will be seen for safety visits at 4 Post Treatment/Study Termination ] [ Designated as safety issue: Yes ]
  • 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 [ Time Frame: Avagacestat-treated patients will be seen for safety visits at 12 Post Treatment/Study Termination ] [ Designated as safety issue: Yes ]
  • 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 [ Time Frame: Avagacestat-treated patients will have a 24 week post treatment skin examination by a dermatologist ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Predictive value of Cerebral Spinal Fluid (CSF) biomarkers (Aβ40, and Aβ42, total Tau, total Tau/Aβ42 ratio, phosphorylated Tau) on progression to dementia [ Time Frame: Baseline (Week 0), Week 2 (optional), Week 24 and Week 104 ] [ Designated as safety issue: No ]

Enrollment: 263
Study Start Date: May 2009
Study Completion Date: July 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Avagacestat (50 mg) Drug: Avagacestat
Capsules, Oral, 50 mg, once daily, 104 - 220 Weeks
Other Name: BMS-708163
Placebo Comparator: Placebo Drug: Placebo
Capsules, Oral, 0 mg, once daily, 104 - 220 Weeks

  Eligibility

Ages Eligible for Study:   45 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient meets clinical criteria for prodromal Alzheimer's disease (MMSE 24-30)
  • Memory complaint by subject or study partner
  • CSF aβ42 levels < 200pg/mL or Total Tau/aβ42 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00890890

  Hide Study Locations
Locations
United States, Alabama
University Of Alabama At Birmingham
Birmingham, Alabama, United States, 35294
United States, Arizona
Pivotal Research Centers
Peoria, Arizona, United States, 85381
21st Century Neurology
Phoenix, Arizona, United States, 85004
Banner Alzheimer'S Institute
Phoenix, Arizona, United States, 85006
Sun Health Research Institue
Sun City, Arizona, United States, 85351
United States, California
Margolin Brain Institute
Fresno, California, United States, 93720
Collaborative Neuroscience Network, Inc.
Long Beach, California, United States, 90806
Mary S. Easton Center
Los Angeles, California, United States, 90095
Pharmacology Research Institute
Newport Beach, California, United States, 92660
Uc Irvine Medical Center
Orange, California, United States, 92868
University Of California, San Diego
San Diego, California, United States, 92161
Affiliated Research Institute
San Diego, California, United States, 92108
Pacific Research Network
San Diego, California, United States, 92103
California Neuroscience Research Medical Group, Inc.
Sherman Oaks, California, United States, 91403
United States, Colorado
Radiant Research, Inc.
Denver, Colorado, United States, 80239
United States, Connecticut
Yale University School Of Medicine
New Haven, Connecticut, United States, 06510
Comprehensive Psychiatric Care
Norwich, Connecticut, United States, 06360
United States, Florida
Meridien Research
Brooksville, Florida, United States, 34601
Brain Matters Research
Delray Beach, Florida, United States, 33445
Md Clinical
Hallandale Beach, Florida, United States, 33009
Compass Research, Llc
Orlando, Florida, United States, 32806
United States, Indiana
Indiana University Medical Center
Indianapolis, Indiana, United States, 46202
United States, Kentucky
Four Rivers Clinical Research, Inc
Paducah, Kentucky, United States, 42003
United States, Massachusetts
Brigham & Women'S Hospital
Boston, Massachusetts, United States, 02115
United States, Missouri
St Louis University
Saint Louis, Missouri, United States, 63104
Washington University School Of Medicine
St. Louis, Missouri, United States, 63108
United States, Nevada
Cleveland Clinic Lou Ruvo Center For Brain Health
Las Vegas, Nevada, United States, 89106
United States, New Jersey
Memory Enhancement Center Of Amercia, Inc.
Eatontown, New Jersey, United States, 07724
Robert Wood Johnson Medical School, Umdnj
New Brunswick, New Jersey, United States, 08903
Global Medical Institutes, Llc
Princeton, New Jersey, United States, 08540
Memory Enhancement Center Of Nj, Inc.
Toms River, New Jersey, United States, 08755
United States, New York
Spri Clinical Trials, Llc
Brooklyn, New York, United States, 11235
Columbia University
New York, New York, United States, 10032
Nyu Langone Medical Center
New York, New York, United States, 10016
University Of Rochester Medical Center
Rochester, New York, United States, 14642
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
Richard H. Weisler, Md, Pa & Assoc.
Raleigh, North Carolina, United States, 27609
Raleigh Neurology Associates, Pa
Raleigh, North Carolina, United States, 27607
Clinical Trials Of America, Inc.
Winston Salem, North Carolina, United States, 27103
Wake Forest University School Of Medicine
Winston-Salem, North Carolina, United States, 27157
United States, Ohio
The Ohio State University
Columbus, Ohio, United States, 43210
Neurology & Neuroscience Center Of Ohio
Toledo, Ohio, United States, 43623
United States, Oklahoma
Tulsa Clinical Research, Llc
Tulsa, Oklahoma, United States, 74104
United States, Oregon
Providence Cognitive Assessment Clinic
Portland, Oregon, United States, 97225
Oregon Health & Science University
Portland, Oregon, United States, 97239
United States, Rhode Island
Butler Hospital
Providence, Rhode Island, United States, 02906
United States, Texas
Senior Adults Specialty Research (Sasr)
Austin, Texas, United States, 78757
The University Of Texas
Dallas, Texas, United States, 75390
United States, Wisconsin
Dean Foundation For Health Research & Education
Middleton, Wisconsin, United States, 53562
Mcw Clinics At Froedtert Hospital
Milwaukee, Wisconsin, United States, 53226
Canada, Alberta
Local Institution
Calgary, Alberta, Canada, T2N 4Z6
Canada, British Columbia
Local Institution
Vancouver, British Columbia, Canada, V6T 2B5
Canada, Ontario
Local Institution
London, Ontario, Canada, N6C 5J1
Local Institution
Toronto, Ontario, Canada, M5T 2S8
Canada, Quebec
Local Institution
Greenfield Park, Quebec, Canada, J4V 2J2
Denmark
Local Institution
Copenhagen, Denmark, 2100
Finland
Local Institution
Turku, Finland, 20520
France
Local Institution
Toulouse, Cedex 9, France, 31059
Local Institution
Bordeaux Cedex, France, 33076
Local Institution
Dijon, France, 21033
Local Institution
Nantes, France, 44093
Local Institution
Rennes Cedex 9, France, 35033
Sweden
Local Institution
Molndal, Sweden, 431 41
Local Institution
Stockholm, Sweden, 141 86
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
No publications provided

Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00890890     History of Changes
Other Study ID Numbers: CN156-018, 2009-010067-16
Study First Received: April 29, 2009
Last Updated: September 4, 2013
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board
Denmark: Danish Medicines Agency
Denmark: Danish Dataprotection Agency
Denmark: The Danish National Committee on Biomedical Research Ethics
Sweden: Medical Products Agency
Sweden: The National Board of Health and Welfare
Sweden: Swedish Data Inspection Board
Sweden: Swedish National Council on Medical Ethics
Finland: Finnish Medicines Agency
Finland: Data Protection Board
Finland: National Advisory Board on Health Care Ethics
Canada: Health Canada
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
France: Institutional Ethical Committee

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on July 20, 2014