To Investigate the Safety and Tolerability of Repeated Subcutaneous Injections of CAD106 in Alzheimer's Patients
Phase 2
Completed
- Conditions
- Alzheimer Disease
- Registration Number
- NCT00956410
- Lead Sponsor
- Novartis
- Brief Summary
This study will evaluate the safety and tolerability of repeated subcutaneous injections of CAD106 in patients with Alzheimer's disease.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 21
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Safety/tolerability assessments at multiple timepoints 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 Evaluate the antibody response after 4 additional injections in the Extension study in patients initially treated with CAD106 in the Core study. 66 weeks Immune response, cognitive and functional assessments at multiple timepoints 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 SAEs collection for two years after completion of the core study, CAD106A2201, or extension study, CAD106A2201E1. 2 years
Trial Locations
- Locations (1)
Novartis Investigative Site
🇬🇧Southampton, United Kingdom
Novartis Investigative Site🇬🇧Southampton, United Kingdom