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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
177
150μg and 450μg doses were reconstituted and administered via intramuscular injection
Identical placebo to CAD106 administered via intramuscular injection
An adjuvant (additive to increase potency ) of low, middle or high doses which was mixed with reconstituted active CAD106
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).
Time frame: Screening and through the end of the study to Week 90
Amyloid beta (Aβ)-specific and Qβ carrier-specific antibody response to CAD106 (with either adjuvant) in serum and cerebrospinal fluid (CSF)
Time frame: 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)
Time frame: 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
Time frame: Screening and through the end of the study to Week 90
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An adjuvant (additive to increase potency) of low, middle and high doses which was mixed with reconstituted active CAD106
Novartis Investigative Site
Costa Mesa, California, United States
Novartis Investigative Site
Boulder, Colorado, United States
Novartis Investigative Site
Hollywood, Florida, United States
Novartis Investigative Site
Indianapolis, Indiana, United States
Novartis Investigative Site
Eatontown, New Jersey, United States
Novartis Investigative Site
Antwerp, Belgium
Novartis Investigative Site
Leuven, Belgium
Novartis Investigative Site
Toronto, Ontario, Canada
Novartis Investigative Site
Toronto, Ontario, Canada
Novartis Investigative Site
Greenfield Park, Quebec, Canada
...and 21 more locations