Alzheimer Disease
Conditions
Keywords
Active immunization, Alzheimer disease, Antibody, Central Nervous System Diseases, Neurodegenerative diseases, Vaccine
Brief summary
This study will evaluate the safety and tolerability of repeated subcutaneous injections of CAD106 in patients with mild Alzheimer's disease.
Interventions
BIOLOGICALPlacebo
BIOLOGICALCAD106
Sponsors
Novartis
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to 85 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
Countries
France, Sweden, Switzerland, United Kingdom
Outcome results
None listed