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| ID | Type | Description | Link |
|---|---|---|---|
| EUDRACT: 2008-005929-11 |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A1 | Active Comparator |
| |
| A2 | Active Comparator |
| |
| A3 | Active Comparator |
| |
| A4 | Active Comparator |
| |
| A5 | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-708163 | Drug | Capsules, Oral, 25 mg, once daily, 24 weeks |
| |
| BMS-708163 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacodynamics effects of Cerebral Spinal Fluid | Baseline, Week 12 and Week 24 | |
| Pharmacodynamics effects of the Alzheimer's Disease Assessment Scale - Cognitive Subscale | Baseline, Week 12, Week 24 and Week 36 |
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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 | ||
| 21st Century Neurology |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22892585 | Derived | Coric V, van Dyck CH, Salloway S, Andreasen N, Brody M, Richter RW, Soininen H, Thein S, Shiovitz T, Pilcher G, Colby S, Rollin L, Dockens R, Pachai C, Portelius E, Andreasson U, Blennow K, Soares H, Albright C, Feldman HH, Berman RM. Safety and tolerability of the gamma-secretase inhibitor avagacestat in a phase 2 study of mild to moderate Alzheimer disease. Arch Neurol. 2012 Nov;69(11):1430-40. doi: 10.1001/archneurol.2012.2194. |
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| Drug |
Capsules, Oral, 50 mg, once daily, 24 weeks |
|
| BMS-708163 | Drug | Capsules, Oral, 100 mg, once daily, 24 weeks |
|
| BMS-708163 | Drug | Capsules, Oral, 125 mg, once daily, 24 weeks |
|
| Placebo | Drug | Capsules, Oral, 0 mg, once daily, 24 weeks |
|
| Pharmacodynamics effects of the Alzheimer's Disease Collaborative Study - Activities of Daily Living scale | Baseline, Week 12, Week 24 and Week 36 |
| 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 |
| 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 |
| Characterize Pharmacodynamics/Pharmacokinetics effects in refining the Pharmacokinetics/Pharmacodynamics model with Phase 2 data | Baseline, Week 12 and Week 24 |
| Characterize Pharmacodynamics/Pharmacokinetics effects by exploring correlations between exposure, biomarkers, and clinical effects | Baseline, Week 12 and Week 24 |
| Characterize Pharmacodynamics/Pharmacokinetics effects by exploring Pharmacokinetics variability, including the correlation between polymorphisms of CYP enzymes | Baseline, Week 12 and Week 24 |
| 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. | Garden Grove | California | 92845 | United States |
| Pacific Institute For Medical Research, Inc. | Los Angeles | California | 90024 | United States |
| Mary S. Easton Center | Los Angeles | California | 90095 | United States |
| Pacific Research Network, Inc | San Diego | California | 92103 | United States |
| California Neuroscience Research Medical Group, Inc. | Sherman Oaks | California | 91403 | 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 |
| Miami Research Associates | South Miami | Florida | 33143 | United States |
| Usf Suncoast Alzheimer'S And Gerontology Center | Tampa | Florida | 33613 | United States |
| Center For Clinical Trials | Venice | Florida | 34285 | United States |
| Indiana University Medical Center | Indianapolis | Indiana | 46202 | United States |
| Four Rivers Clinical Research, Inc | Paducah | Kentucky | 42003 | United States |
| Memory Enhancement Center Of Amercia, Inc. | Eatontown | New Jersey | 07724 | United States |
| Global Medical Institutes, Llc | Princeton | New Jersey | 08540 | United States |
| Columbia University | New York | New York | 10032 | United States |
| University Of Rochester | Rochester | New York | 14620 | United States |
| Richard H. Weisler, Md, Pa & Associates | Raleigh | North Carolina | 27609 | 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 |
| Professional Neurological Associates, Pc | Dunmore | Pennsylvania | 18512 | United States |
| The Clinical Trial Center Llc | Jenkintown | Pennsylvania | 19046 | United States |
| R.I. Mood & Memory Research Institute | East Providence | Rhode Island | 02914 | United States |
| Butler Hospital | Providence | Rhode Island | 02906 | United States |
| The University Of Texas | Dallas | Texas | 75390 | United States |
| Dean Foundation For Health Research & Education | Middleton | Wisconsin | 53562 | United States |
| Local Institution | Odense | 5000 | Denmark |
| Local Institution | Kuopio | 70210 | Finland |
| Local Institution | Turku | 20520 | Finland |
| Local Institution | Malmö | 212 24 | Sweden |
| 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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