Clinical trial NCT01097096: Safety, Tolerability and Abeta-specific Antibody Response of Repeated i.m. Injections of Adjuvanted CAD106 in Mild Alzheimer Patients
Official title: A 90-week, Multi-center, Randomized, Double-blind, Placebo-controlled Study in Patients With Mild Alzheimer's Disease (AD) to Investigate the Safety, Tolerability and Abeta-specific Antibody Response Following Repeated i.m. Injections of Adjuvanted CAD106
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Alzheimer's Disease
Keywords: Active immunization
Alzheimer disease
Antibody
Central Nervous System Diseases
Neurodegenerative diseases
Vaccine
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2010-04-01
Enrollment: 177
Sex: ALL
Maximum age (years): 85
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: 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).
timeFrame: Screening and through the end of the study to Week 90
Secondary outcomes:
measure: Amyloid beta (Aβ)-specific and Qβ carrier-specific antibody response to CAD106 (with either adjuvant) in serum and cerebrospinal fluid (CSF)
timeFrame: Screening and through the end of the study to Week 90
measure: Amyloid beta (Aβ)-specific and Qβ carrier-specific T-cell response to CAD106 (with either adjuvant) using peripheral blood mononuclear cells (PBMCs)
timeFrame: Screening and at week 8
measure: 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
timeFrame: Screening and through the end of the study to Week 90
Other outcomes:
Locations:
city: Costa Mesa
country: United States
facility: Novartis Investigative Site
state: California
city: Boulder
country: United States
facility: Novartis Investigative Site
state: Colorado
city: Hollywood
country: United States
facility: Novartis Investigative Site
state: Florida
city: Indianapolis
country: United States
facility: Novartis Investigative Site
state: Indiana
city: Eatontown
country: United States
facility: Novartis Investigative Site
state: New Jersey
city: Antwerpen
country: Belgium
facility: Novartis Investigative Site
city: Leuven
country: Belgium
facility: Novartis Investigative Site
city: Toronto
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: Toronto
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: Greenfield Park
country: Canada
facility: Novartis Investigative Site
state: Quebec
city: Montreal
country: Canada
facility: Novartis Investigative Site
state: Quebec
city: Magdeburg
country: Germany
facility: Novartis Investigative Site
city: Nuernberg
country: Germany
facility: Novartis Investigative Site
city: Brescia
country: Italy
facility: Novartis Investigative Site
state: BS
city: Firenze
country: Italy
facility: Novartis Investigative Site
state: FI
city: Genova
country: Italy
facility: Novartis Investigative Site
state: GE
city: Milano
country: Italy
facility: Novartis Investigative Site
state: MI
city: Roma
country: Italy
facility: Novartis Investigative Site
state: RM
city: Roma
country: Italy
facility: Novartis Investigative Site
state: RM
city: Amsterdam
country: Netherlands
facility: Novartis Investigative Site
city: Stavanger
country: Norway
facility: Novartis Investigative Site
city: Sant Cugat
country: Spain
facility: Novartis Investigative Site
state: Barcelona
city: Barcelona
country: Spain
facility: Novartis Investigative Site
state: Catalunya
city: Barcelona
country: Spain
facility: Novartis Investigative Site
state: Cataluña
city: Barcelona
country: Spain
facility: Novartis Investigative Site
state: Cataluña
city: Barakaldo
country: Spain
facility: Novartis Investigative Site
state: País Vasco
city: Mölndal
country: Sweden
facility: Novartis Investigative Site
city: Stockholm
country: Sweden
facility: Novartis Investigative Site
city: Basel
country: Switzerland
facility: Novartis Investigative Site
city: Biel
country: Switzerland
facility: Novartis Investigative Site
city: Lausanne
country: Switzerland
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: