To Investigate the Safety and Tolerability of Repeated Subcutaneous Injections of CAD106 in Alzheimer's Patients
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ClinicalTrials.gov Identifier: NCT01023685 |
Recruitment Status :
Completed
First Posted : December 2, 2009
Last Update Posted : December 17, 2020
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Alzheimer Disease | Biological: CAD106 | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 24 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | An Open-label Extension to a 52-week, Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel Group Study in Patients With Alzheimer's Disease to Investigate the Safety and Tolerability of Repeated Subcutaneous Injections of CAD106. |
Study Start Date : | December 2009 |
Actual Primary Completion Date : | February 2012 |
Actual Study Completion Date : | February 2012 |

Arm | Intervention/treatment |
---|---|
Experimental: CAD106 |
Biological: CAD106 |
- Safety/tolerability assessments at multiple time points including but not limited to screening, and through to the end of the study to week 66. [ Time Frame: 66 weeks ]
- Collect long-term safety information through SAE's collection for two years after completion of the extension study. [ Time Frame: 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. [ Time Frame: 66 weeks ]
- Evaluate the antibody response after 4 additional injections in the Extension study, in patients initially treated with CAD106 in the Core study. [ Time Frame: 66 weeks ]

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Ages Eligible for Study: | Child, Adult, Older Adult |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients who have completed the core study with no significant safety concerns
Exclusion Criteria:
- Diagnosis of other neurodegenerative disease and/or psychiatric disorders (with the exception of successfully treated depression).
- Diagnosis or presence of an active, uncontrolled seizure disorder and/or cerebrovascular disease.
- Diagnosis or presence of an active autoimmune and/or with an acute or chronic inflammation.
Other protocol-defined inclusion/exclusion criteria may apply

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01023685
United States, California | |
ATP Clinical Research, Inc. | |
Costa Mesa, California, United States, 92626 | |
United States, Colorado | |
Alpin Research Center | |
Boulder, Colorado, United States, 80304 | |
United States, Florida | |
Sunrise Clinical Research, Inc. | |
Hollywood, Florida, United States, 33021 | |
United States, Illinois | |
Alexian Brothers Neuroscience Institute | |
Elk Grove Village, Illinois, United States, 60007 | |
United States, Indiana | |
Indiana University School of Medicine | |
Indianapolis, Indiana, United States, 46202 | |
United States, Pennsylvania | |
Drexel University College of Medicine | |
Philadelphia, Pennsylvania, United States, 19102 | |
United States, Tennessee | |
Volunteer Research Group | |
Knoxville, Tennessee, United States, 37920 | |
United States, Texas | |
University of Texas Southwestern | |
Dallas, Texas, United States, 75390 |
Study Director: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Novartis |
ClinicalTrials.gov Identifier: | NCT01023685 |
Other Study ID Numbers: |
CCAD106A2202E1 |
First Posted: | December 2, 2009 Key Record Dates |
Last Update Posted: | December 17, 2020 |
Last Verified: | June 2013 |
Active immunization Alzheimer disease Antibody |
Central Nervous System diseases Neurodegenerative diseases Vaccine |
Alzheimer Disease Dementia Brain Diseases Central Nervous System Diseases Nervous System Diseases |
Tauopathies Neurodegenerative Diseases Neurocognitive Disorders Mental Disorders |