NCT00956410CompletedPhase 2
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
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Novartis
- Enrollment
- 21
- Locations
- 4
- Primary Endpoint
- Safety/tolerability assessments at multiple timepoints including but not limited to screening, and through to the end of the study to week 66.
Study Overview
Brief Summary
This study will evaluate the safety and tolerability of repeated subcutaneous injections of CAD106 in patients with Alzheimer's disease.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 40 Years to 85 Years (Adult, Older Adult)
- Sex
- 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.
Arms & Interventions
CAD106
Experimental
Intervention: CAD106 (Biological)
Outcomes
Primary Outcomes
Safety/tolerability assessments at multiple timepoints including but not limited to screening, and through to the end of the study to week 66.
Time Frame: 66 weeks
Secondary Outcomes
- 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)
Investigators
Study Sites (4)
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