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| ID | Type | Description | Link |
|---|---|---|---|
| 2009-010067-16 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Avagacestat (50 mg) | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Avagacestat | Drug | Capsules, Oral, 50 mg, once daily, 104 - 220 Weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
| 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 | |
| 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 | |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Predictive value of Cerebral Spinal Fluid (CSF) biomarkers (Aβ40, and Aβ42, total Tau, total Tau/Aβ42 ratio, phosphorylated Tau) on progression to dementia | Baseline (Week 0), Week 2 (optional), Week 24 and Week 104 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Of Alabama At Birmingham | Birmingham | Alabama | 35294 | United States | ||
| Pivotal Research Centers |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26414022 | Derived | Coric V, Salloway S, van Dyck CH, Dubois B, Andreasen N, Brody M, Curtis C, Soininen H, Thein S, Shiovitz T, Pilcher G, Ferris S, Colby S, Kerselaers W, Dockens R, Soares H, Kaplita S, Luo F, Pachai C, Bracoud L, Mintun M, Grill JD, Marek K, Seibyl J, Cedarbaum JM, Albright C, Feldman HH, Berman RM. Targeting Prodromal Alzheimer Disease With Avagacestat: A Randomized Clinical Trial. JAMA Neurol. 2015 Nov;72(11):1324-33. doi: 10.1001/jamaneurol.2015.0607. |
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| Placebo | Drug | Capsules, Oral, 0 mg, once daily, 104 - 220 Weeks |
|
| Peoria |
| Arizona |
| 85381 |
| 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. | Long Beach | California | 90806 | United States |
| Mary S. Easton Center | Los Angeles | California | 90095 | United States |
| Pharmacology Research Institute | Newport Beach | California | 92660 | United States |
| Uc Irvine Medical Center | Orange | California | 92868 | United States |
| Pacific Research Network | San Diego | California | 92103 | United States |
| Affiliated Research Institute | San Diego | California | 92108 | United States |
| University Of California, San Diego | San Diego | California | 92161 | United States |
| California Neuroscience Research Medical Group, Inc. | Sherman Oaks | California | 91403 | United States |
| Radiant Research, Inc. | Denver | Colorado | 80239 | 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 |
| Indiana University Medical Center | Indianapolis | Indiana | 46202 | United States |
| Four Rivers Clinical Research, Inc | Paducah | Kentucky | 42003 | United States |
| Brigham & Women'S Hospital | Boston | Massachusetts | 02115 | United States |
| St Louis University | St Louis | Missouri | 63104 | United States |
| Washington University School Of Medicine | St Louis | Missouri | 63108 | United States |
| Cleveland Clinic Lou Ruvo Center For Brain Health | Las Vegas | Nevada | 89106 | United States |
| Memory Enhancement Center Of Amercia, Inc. | Eatontown | New Jersey | 07724 | United States |
| Robert Wood Johnson Medical School, Umdnj | New Brunswick | New Jersey | 08903 | United States |
| Global Medical Institutes, Llc | Princeton | New Jersey | 08540 | United States |
| Memory Enhancement Center Of Nj, Inc. | Toms River | New Jersey | 08755 | United States |
| Spri Clinical Trials, Llc | Brooklyn | New York | 11235 | United States |
| Nyu Langone Medical Center | New York | New York | 10016 | United States |
| Columbia University | New York | New York | 10032 | United States |
| University Of Rochester Medical Center | Rochester | New York | 14642 | United States |
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| Raleigh Neurology Associates, Pa | Raleigh | North Carolina | 27607 | United States |
| Richard H. Weisler, Md, Pa & Assoc. | Raleigh | North Carolina | 27609 | United States |
| Clinical Trials Of America, Inc. | Winston-Salem | North Carolina | 27103 | United States |
| Wake Forest University School Of Medicine | Winston-Salem | North Carolina | 27157 | 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 |
| Providence Cognitive Assessment Clinic | Portland | Oregon | 97225 | United States |
| Oregon Health & Science University | Portland | Oregon | 97239 | United States |
| Butler Hospital | Providence | Rhode Island | 02906 | United States |
| Senior Adults Specialty Research (Sasr) | Austin | Texas | 78757 | United States |
| The University Of Texas | Dallas | Texas | 75390 | United States |
| Dean Foundation For Health Research & Education | Middleton | Wisconsin | 53562 | United States |
| Mcw Clinics At Froedtert Hospital | Milwaukee | Wisconsin | 53226 | United States |
| Local Institution | Calgary | Alberta | T2N 4Z6 | Canada |
| Local Institution | Vancouver | British Columbia | V6T 2B5 | Canada |
| Local Institution | London | Ontario | N6C 5J1 | Canada |
| Local Institution | Toronto | Ontario | M5T 2S8 | Canada |
| Local Institution | Greenfield Park | Quebec | J4V 2J2 | Canada |
| Local Institution | Copenhagen | 2100 | Denmark |
| Local Institution | Turku | 20520 | Finland |
| Local Institution | Toulouse | Cedex 9 | 31059 | France |
| Local Institution | Bordeaux | 33076 | France |
| Local Institution | Dijon | 21033 | France |
| Local Institution | Nantes | 44093 | France |
| Local Institution | Rennes | 35033 | France |
| Local Institution | Mölndal | 431 41 | Sweden |
| Local Institution | Stockholm | 141 86 | Sweden |
| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D024801 | Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C554092 | BMS 708163 |
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