Trial record 4 of 46 for:
prodromal
A Multicenter, Double Blind, Placebo-Controlled, Safety and Tolerability Study of BMS-708163 in Patients With Prodromal Alzheimer's Disease
This study is ongoing, but not recruiting participants.
Sponsor:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00890890
First received: April 29, 2009
Last updated: July 24, 2012
Last verified: July 2012
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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:
Genetics Home Reference related topics:
Alzheimer disease
MedlinePlus related topics:
Alzheimer's Disease
U.S. FDA Resources
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 ]
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 ]
| Estimated Enrollment: | 270 |
| Study Start Date: | May 2009 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | December 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00890890
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| 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 | |
| Banner Research Institute | |
| Sun City, Arizona, United States, 85351 | |
| United States, California | |
| Margolin Brain Institute | |
| Fresno, California, United States, 93720 | |
| University Of California San Diego | |
| La Jolla, California, United States, 92037 | |
| 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 | |
| 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 | |
| Miami Research Associates | |
| South Miami, Florida, United States, 33143 | |
| 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 | |
| St 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 | |
| Social Psychiatry Research Institute | |
| 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, 14620 | |
| United States, North Carolina | |
| Duke University Medical Center | |
| Durham, North Carolina, United States, 27710 | |
| Raleigh Neurology Associates, Pa | |
| Raleigh, North Carolina, United States, 27607 | |
| Richard H. Weisler, Md, Pa & Assoc. | |
| Raleigh, North Carolina, United States, 27609 | |
| 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 | |
| Ottawa, Ontario, Canada, K1N 5C8 | |
| Local Institution | |
| Toronto, Ontario, Canada, M5T 2S8 | |
| Local Institution | |
| Whitby, Ontario, Canada, L1N 5S9 | |
| Canada, Quebec | |
| Local Institution | |
| Greenfield Park, Quebec, Canada, J4V 2J2 | |
| Local Institution | |
| Sherbrooke, Quebec, Canada, J1J 3H5 | |
| Denmark | |
| Local Institution | |
| Aarhus C, Denmark, 8000 | |
| Local Institution | |
| Copenhagen, Denmark, 2100 | |
| Finland | |
| Local Institution | |
| Kuopio, Finland, 70210 | |
| 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 | |
| Lille, France, 59037 | |
| Local Institution | |
| Nantes, France, 44093 | |
| Local Institution | |
| Rennes Cedex 9, France, 35033 | |
| Netherlands | |
| Local Institution | |
| 'S-Hertogenbosch, Netherlands, 5223 GZ | |
| Sweden | |
| Local Institution | |
| Malmo, Sweden, 212 24 | |
| 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: | July 24, 2012 |
| 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 May 16, 2013