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Safety, Tolerability and Abeta-specific Antibody Response of Repeated i.m. Injections of Adjuvanted CAD106 in Mild Alzheimer Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01097096
First received: March 29, 2010
Last updated: February 7, 2013
Last verified: February 2013
History of Changes

March 29, 2010
February 7, 2013
March 2010
December 2012   (final data collection date for primary outcome 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). [ Time Frame: Screening and through the end of the study to Week 90 ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01097096 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Safety, Tolerability and Abeta-specific Antibody Response of Repeated i.m. Injections of Adjuvanted CAD106 in Mild Alzheimer Patients
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

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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Alzheimer's Disease
Biological: CAD106
  • Active Comparator: CAD106 150μg + Adjuvant 1 at middle dose
    Intervention: Biological: CAD106
  • Active Comparator: CAD106 150μg + Adjuvant 1 at low dose
    Intervention: Biological: CAD106
  • Placebo Comparator: Placebo + Adjuvant 1 at middle dose
    Intervention: Biological: CAD106
  • Active Comparator: CAD106 150μg + Adjuvant 2 at middle dose
    Intervention: Biological: CAD106
  • Active Comparator: CAD106 150μg + Adjuvant 2 at low dose
    Intervention: Biological: CAD106
  • Placebo Comparator: Placebo + Adjuvant 2 at middle dose
    Intervention: Biological: CAD106
  • Active Comparator: CAD106 450μg + either Adjuvant 1 or 2 at middle dose
    Intervention: Biological: CAD106
  • Active Comparator: CAD106 450μg + either Adjuvant 1 or 2 at low dose
    Intervention: Biological: CAD106
  • Placebo Comparator: Placebo + either Adjuvant 1 or 2 at middle dose
    Intervention: Biological: CAD106
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
177
December 2012
December 2012   (final data collection date for primary outcome measure)

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
Both
up to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Belgium,   Canada,   Germany,   Italy,   Netherlands,   Norway,   Spain,   Sweden,   Switzerland
 
NCT01097096
CCAD106A2203, 2009-012394-35
Not Provided
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP