Safety and Tolerability of Repeated Subcutaneous Injections of CAD106 in Mild Alzheimer's Patients.
Phase 2
Completed
- Conditions
- Alzheimer Disease
- Registration Number
- NCT00733863
- Lead Sponsor
- Novartis
- Brief Summary
This study will evaluate the safety and tolerability of repeated subcutaneous injections of CAD106 in patients with mild Alzheimer's disease.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 27
Inclusion Criteria
- Diagnosis of Mild Alzheimer's Disease
- Mini-Mental State Examination (MMSE) 20 to 26 at screening, untreated or on stable dose of cholinesterase inhibitor or memantine over the last 6 weeks
Exclusion Criteria
- Previously participated in an AD vaccine study and received active treatment
- History or presence of an active autoimmune and/or with an acute or chronic inflammation, and/or clinically relevant atopic condition.
- History or presence of seizures and/or cerebrovascular disease.
- Presence of an other neurodegenerative disease and/or psychiatric disorders (with the exception of successfully treated depression)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Safety/tolerability assessments at multiple timepoints including but not limited to screening, baseline, and through the end of the study to Week 52. 52 weeks
- Secondary Outcome Measures
Name Time Method Immune response, cognitive and functional assessments at multiple timepoints including but not limited to baseline and through the end of the study to Week 52. 52 weeks
Trial Locations
- Locations (4)
Centre Hospitalier Universitaire Pellegrin
🇫🇷Bordeaux, France
Karolinska Universitetssjukhuset Huddinge
🇸🇪Stockholm, Sweden
NeuroPsychologieZentrum
🇨🇭Basel, Switzerland
Moorgreen Hospital
🇬🇧Southampton, United Kingdom
Centre Hospitalier Universitaire Pellegrin🇫🇷Bordeaux, France