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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
  Purpose

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.


Condition Intervention Phase
Alzheimer's Disease
 Biological: CAD106
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 177
Study Start Date: March 2010
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: CAD106 150μg + Adjuvant 1 at middle dose Biological: CAD106
Active Comparator: CAD106 150μg + Adjuvant 1 at low dose Biological: CAD106
Placebo Comparator: Placebo + Adjuvant 1 at middle dose Biological: CAD106
Active Comparator: CAD106 150μg + Adjuvant 2 at middle dose Biological: CAD106
Active Comparator: CAD106 150μg + Adjuvant 2 at low dose Biological: CAD106
Placebo Comparator: Placebo + Adjuvant 2 at middle dose Biological: CAD106
Active Comparator: CAD106 450μg + either Adjuvant 1 or 2 at middle dose Biological: CAD106
Active Comparator: CAD106 450μg + either Adjuvant 1 or 2 at low dose Biological: CAD106
Placebo Comparator: Placebo + either Adjuvant 1 or 2 at middle dose Biological: CAD106

  Eligibility

Ages Eligible for Study:   up to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01097096

  Show 31 Study Locations
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01097096     History of Changes
Other Study ID Numbers: CCAD106A2203, 2009-012394-35
Study First Received: March 29, 2010
Last Updated: February 7, 2013
Health Authority: United States: Food and Drug Administration
Canada: Health Canada
Belgium: Federal Agency for Medicinal Products and Health Products
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Germany: Paul-Ehrlich-Institut
Switzerland: Swissmedic
Sweden: Medical Products Agency
Norway: Norwegian Medicines Agency
Spain: Spanish Agency of Medicines
Italy: The Italian Medicines Agency

Keywords provided by Novartis:
Active immunization
Alzheimer disease
Antibody
 Central Nervous System Diseases
Neurodegenerative diseases
Vaccine

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
 Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Antibodies
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013