Safety, Tolerability and Abeta-specific Antibody Response of Repeated i.m. Injections of Adjuvanted CAD106 in Mild Alzheimer Patients
Alzheimer's Disease
About this trial
This is an interventional treatment trial for Alzheimer's Disease focused on measuring Active immunization, Alzheimer disease, Antibody, Central Nervous System Diseases, Neurodegenerative diseases, Vaccine
Eligibility Criteria
Inclusion Criteria:
- Male and/or female patients below 85 years of age (inclusive)
- Diagnosis of mild Alzheimer's Disease
- Mini-Mental State Examination (MMSE) 20 to 26 (inclusive) at screening, untreated or on stable dose of cholinesterase inhibitor or memantine over the last 4 weeks prior to clinical assessments
Exclusion Criteria:
- Previously participated in an AD vaccine study and received active treatment
- History or presence of an active autoimmune disease
- History or presence of seizure disorder
- Presence of significant coronary heart disease and/or cerebrovascular disease
- Presence of other neurodegenerative disease and/or psychiatric disorders (with the exception of successfully treated depression)
- Advanced, severe, progressive or unstable disease that might interfere with the safety, tolerability and pharmacodynamic assessments of the patient
Other protocol-defined inclusion/exclusion criteria may apply
Sites / Locations
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm 8
Arm 9
Active Comparator
Active Comparator
Placebo Comparator
Active Comparator
Active Comparator
Placebo Comparator
Active Comparator
Active Comparator
Placebo Comparator
CAD106 150μg + Adjuvant 1 at middle dose
CAD106 150μg + Adjuvant 1 at low dose
Placebo + Adjuvant 1 at middle dose
CAD106 150μg + Adjuvant 2 at middle dose
CAD106 150μg + Adjuvant 2 at low dose
Placebo + Adjuvant 2 at middle dose
CAD106 450μg + either Adjuvant 1 or 2 at middle dose
CAD106 450μg + either Adjuvant 1 or 2 at low dose
Placebo + either Adjuvant 1 or 2 at middle dose