Alzheimer's Disease
Conditions
Keywords
Active immunization, Alzheimer disease, Antibody, Central Nervous System Diseases, Neurodegenerative diseases, Vaccine
Brief summary
This study will assess the safety, tolerability and Abeta-specific antibody response of repeated intra-muscular injections of adjuvanted CAD106 in patients with mild Alzheimer's Disease.
Interventions
BIOLOGICALCAD106
150μg and 450μg doses were reconstituted and administered via intramuscular injection
BIOLOGICALPlacebo
Identical placebo to CAD106 administered via intramuscular injection
BIOLOGICALAlum
An adjuvant (additive to increase potency ) of low, middle or high doses which was mixed with reconstituted active CAD106
BIOLOGICALMF59
An adjuvant (additive to increase potency) of low, middle and high doses which was mixed with reconstituted active CAD106
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
No minimum to 85 Years
Healthy volunteers
No
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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and tolerability assessments (physical/neurological examinations, electrocardiogram (ECG), vital signs, standard and special laboratory evaluations, Magnetic Resonance Imaging (MRIs), Adverse events / Serious adverse events (AE/SAE) monitoring). | Screening and through the end of the study to Week 90 |
Secondary
| Measure | Time frame |
|---|---|
| Amyloid beta (Aβ)-specific and Qβ carrier-specific antibody response to CAD106 (with either adjuvant) in serum and cerebrospinal fluid (CSF) | Screening and through the end of the study to Week 90 |
| Amyloid beta (Aβ)-specific and Qβ carrier-specific T-cell response to CAD106 (with either adjuvant) using peripheral blood mononuclear cells (PBMCs) | Screening and at week 8 |
| Changes over time of the concentrations of disease related markers (Aβ1-40 and Aβ1-42 in plasma; Aβ1-40, Aβ1-42, total-tau, phospho-tau in CSF, or other markers) in patients with mild AD receiving CAD106 (with either adjuvant) compared to placebo | Screening and through the end of the study to Week 90 |
Countries
Belgium, Canada, Germany, Italy, Netherlands, Norway, Spain, Sweden, Switzerland, United States
Outcome results
None listed