Alzheimer Disease
Conditions
Keywords
Active immunization, Alzheimer disease, Antibody, Central Nervous System diseases, Neurodegenerative diseases, Vaccine
Brief summary
This study will investigate the Safety and Tolerability of Repeated Subcutaneous Injections of CAD106 in Alzheimer's Patients.
Interventions
BIOLOGICALCAD106
Sponsors
Novartis
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Collect long-term safety information through SAE's collection for two years after completion of the extension study. | 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. | 66 weeks |
| Evaluate the antibody response after 4 additional injections in the Extension study, in patients initially treated with CAD106 in the Core study. | 66 weeks |
Countries
United States
Outcome results
None listed