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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-004065-33 | EudraCT Number |
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The purpose of the study is to evaluate safety and the pharmacodynamic effects of BMS-241027 on cerebrospinal fluid (CSF) Tau, connectivity magnetic resonance imaging (MRI), and computerized cognitive tests in mild Alzheimer's disease (AD) subjects, following 9 weekly intravenous (IV) infusions of BMS-241027
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1: BMS-241027 (0.003 mg/kg) | Experimental |
| |
| Arm 2: BMS-241027 (0.01 mg/kg) | Experimental |
| |
| Arm 3: BMS-241027 (0.03 mg/kg) | Experimental |
| |
| Arm 4: Placebo matching BMS-241027 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-241027 | Drug | Intravenous (IV), 0.003 mg/kg, Once Weekly, 9 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Safety assessments: based on frequency of Serious Adverse Events (SAEs), frequency of Adverse events (AEs), discontinuation due to AEs and dose reduction | Within the first 70 day after first dose | |
| Biomarker Measures: CSF levels of Tau N-terminal domain fragments | Within the first 70 day after first dose |
| Measure | Description | Time Frame |
|---|---|---|
| Effects of BMS-241027 on CSF levels of the mid-domain Tau fragment | Within the first 70 days after first dose | |
| Effects of BMS-241027 on cognitive performance using computerized cognitive tests | Weeks 3, 6 and 9 |
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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 |
|---|---|---|---|---|---|---|
| Anaheim Clinical Trials Llc | Anaheim | California | 92801 | United States | ||
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| BMS-241027 |
| Drug |
Intravenous (IV), 0.01 mg/kg, Once Weekly, 9 weeks |
|
| BMS-241027 | Drug | Intravenous (IV), 0.03 mg/kg, Once Weekly, 9 weeks |
|
| Placebo matching BMS-241027 | Drug | Intravenous (IV), 0.0 mg/kg, Once Weekly, 9 weeks |
|
| Effects of BMS-241027 on connectivity MRI | Within the first 70 days after first dose |
| Maximal observed plasma concentration (Cmax) of BMS-241027 in subjects with mild Alzheimer's disease | Intensive pharmacokinetic parameter Cmax will be derived from subgroups of subjects at Week 7 | Weeks 1, 4, and 9 |
| Observed plasma concentration at 24 hours post dose (C24) of BMS-241027 in subjects with mild Alzheimer's disease | Intensive pharmacokinetic parameter C24 will be derived from subgroups of subjects at Week 7 | Weeks 1, 4, and 9 |
| Time of maximal observed plasma concentration (Tmax) of BMS-241027 in subjects with mild Alzheimer's disease | Intensive pharmacokinetic parameter Tmax will be derived from subgroups of subjects at Week 7 | Weeks 1, 4, and 9 |
| Area under the concentration-time curve in one dosing interval [AUC(TAU)] of BMS-241027 in subjects with mild Alzheimer's disease | Intensive pharmacokinetic parameter AUC(TAU) will be derived from subgroups of subjects at Week 7 | Weeks 1, 4, and 9 |
| Safety assessments: based on vital sign measurements, ECGs and clinical laboratory tests | Within the first 70 day after first dose |
| Effects of BMS-241027 on CSF levels of neurofilaments | Within the first 70 days after first dose |
| Long Beach |
| California |
| 90806 |
| United States |
| Ucsf Memory And Aging Center | San Francisco | California | 94158 | United States |
| Alpine Clinical Research Center, Inc. | Boulder | Colorado | 80304 | United States |
| Associated Neurologists Of Southern Connecticut, P.C. | Fairfield | Connecticut | 06824 | United States |
| Compass Research, Llc | Orlando | Florida | 32806 | United States |
| Palm Beach Neurological Center Advanced Research Consultants | Palm Beach Gardens | Florida | 33410 | United States |
| Alexian Brothers Neurosciences Institute Clinical Research | Elk Grove Village | Illinois | 60007 | United States |
| Brigham And Women'S Hospital | Boston | Massachusetts | 02115 | United States |
| Michigan State University | East Lansing | Michigan | 48824 | United States |
| The Ohio State University | Columbus | Ohio | 43210 | United States |
| The Clinical Trial Center, Llc | Jenkintown | Pennsylvania | 19046 | United States |
| Hospital Of The University Of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| Penn Memory Center | Philadelphia | Pennsylvania | 19104 | United States |
| Lifetree Clinical Research | Salt Lake City | Utah | 84106 | United States |
| Local Institution | London | Ontario | N6C 5J1 | Canada |
| Local Institution | Toronto | Ontario | M3B 2S7 | Canada |
| Local Institution | Greenfield Park | Quebec | J4V 2J2 | Canada |
| Local Institution | Toulouse | Cedex 9 | 31059 | France |
| Local Institution | Lille | 59037 | France |
| Local Institution | Paris | 75013 | France |
| Local Institution | Berlin | 14050 | Germany |
| Local Institution | Heidelberg | 69115 | Germany |
| 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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