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This study will investigate the Safety and Tolerability of Repeated Subcutaneous Injections of CAD106 in Alzheimer's Patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CAD106 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CAD106 | Biological |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety/tolerability assessments at multiple time points including but not limited to screening, and through to the end of the study to week 66. | 66 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Collect long-term safety information through SAE's collection for two years after completion of the extension study. | 2 years | |
| Immune response, cognitive and functional assessments at multiple time points including but not limited to baseline, and through to the end of the study to week 66. |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ATP Clinical Research, Inc. | Costa Mesa | California | 92626 | United States | ||
| Alpin Research Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25918556 | Derived | Farlow MR, Andreasen N, Riviere ME, Vostiar I, Vitaliti A, Sovago J, Caputo A, Winblad B, Graf A. Long-term treatment with active Abeta immunotherapy with CAD106 in mild Alzheimer's disease. Alzheimers Res Ther. 2015 Apr 27;7(1):23. doi: 10.1186/s13195-015-0108-3. eCollection 2015. |
| Label | URL |
|---|---|
| Results for CCAD106A2202E1 from the Novartis Clinical Trials website | View source |
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| 66 weeks |
| Evaluate the antibody response after 4 additional injections in the Extension study, in patients initially treated with CAD106 in the Core study. | 66 weeks |
| Boulder |
| Colorado |
| 80304 |
| United States |
| Sunrise Clinical Research, Inc. | Hollywood | Florida | 33021 | United States |
| Alexian Brothers Neuroscience Institute | Elk Grove Village | Illinois | 60007 | United States |
| Indiana University School of Medicine | Indianapolis | Indiana | 46202 | United States |
| Drexel University College of Medicine | Philadelphia | Pennsylvania | 19102 | United States |
| Volunteer Research Group | Knoxville | Tennessee | 37920 | United States |
| University of Texas Southwestern | Dallas | Texas | 75390 | United States |
| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| D002493 | Central Nervous System Diseases |
| D019636 | Neurodegenerative Diseases |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D009422 | Nervous System Diseases |
| D024801 | Tauopathies |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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