To Investigate the Safety and Tolerability of Repeated Subcutaneous Injections of CAD106 in Alzheimer's Patients

This study has been completed.
Information provided by (Responsible Party):
Novartis Identifier:
First received: August 10, 2009
Last updated: November 16, 2011
Last verified: November 2011

This study will evaluate the safety and tolerability of repeated subcutaneous injections of CAD106 in patients with Alzheimer's disease.

Condition Intervention Phase
Alzheimer Disease
Biological: CAD106
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-label Extension to a 52-week, Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel Group Study in Patients With Alzheimer's Disease to Investigate the Safety and Tolerability of Repeated Subcutaneous Injections of CAD106

Resource links provided by NLM:

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Safety/tolerability assessments at multiple timepoints including but not limited to screening, and through to the end of the study to week 66. [ Time Frame: 66 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Immune response, cognitive and functional assessments at multiple timepoints including but not limited to baseline and through to the end of the study to week 66. [ Time Frame: 66 weeks ] [ Designated as safety issue: No ]
  • Evaluate the antibody response after 4 additional injections in the Extension study in patients initially treated with CAD106 in the Core study. [ Time Frame: 66 weeks ] [ Designated as safety issue: No ]
  • Collect long-term safety information through SAEs collection for two years after completion of the core study, CAD106A2201, or extension study, CAD106A2201E1. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Enrollment: 21
Study Start Date: September 2009
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CAD106 Biological: CAD106


Ages Eligible for Study:   40 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients who have completed the Core study with no significant safety concerns

Exclusion Criteria:

  • Diagnosis of other neurodegenerative disease and/or psychiatric disorders (with the exception of successfully treated depression).
  • Diagnosis or presence of an active, uncontrolled seizure disorder and/or cerebrovascular disease.
  • diagnosis or presence of an active autoimmune and/or with an acute or chronic inflammation.
  Contacts and Locations
Please refer to this study by its identifier: NCT00956410

Novartis Investigative Site
Bordeaux, France
Novartis Investigative Site
Stockholm, Sweden
Novartis Investigative Site
Basel, Switzerland
United Kingdom
Novartis Investigative Site
Southampton, United Kingdom
Sponsors and Collaborators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis Identifier: NCT00956410     History of Changes
Other Study ID Numbers: CCAD106A2201E1
Study First Received: August 10, 2009
Last Updated: November 16, 2011
Health Authority: Switzerland: Swissmedic

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

Additional relevant MeSH terms:
Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders processed this record on April 21, 2014