To Investigate the Safety and Tolerability of Repeated Subcutaneous Injections of CAD106 in Alzheimer's Patients
Phase 2
Completed
- Conditions
- Alzheimer Disease
- Interventions
- Biological: CAD106
- Registration Number
- NCT01023685
- Lead Sponsor
- Novartis
- Brief Summary
This study will investigate the Safety and Tolerability of Repeated Subcutaneous Injections of CAD106 in Alzheimer's Patients.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 24
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description CAD106 CAD106 -
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method 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. 66 weeks Collect long-term safety information through SAE's collection for two years after completion of the extension study. 2 years Evaluate the antibody response after 4 additional injections in the Extension study, in patients initially treated with CAD106 in the Core study. 66 weeks
Trial Locations
- Locations (8)
University of Texas Southwestern
🇺🇸Dallas, Texas, United States
Alpin Research Center
🇺🇸Boulder, Colorado, United States
ATP Clinical Research, Inc.
🇺🇸Costa Mesa, California, United States
Sunrise Clinical Research, Inc.
🇺🇸Hollywood, Florida, United States
Volunteer Research Group
🇺🇸Knoxville, Tennessee, United States
Alexian Brothers Neuroscience Institute
🇺🇸Elk Grove Village, Illinois, United States
Indiana University School of Medicine
🇺🇸Indianapolis, Indiana, United States
Drexel University College of Medicine
🇺🇸Philadelphia, Pennsylvania, United States