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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00956410
Recruitment Status : Completed
First Posted : August 11, 2009
Last Update Posted : November 17, 2011
Sponsor:
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment Phase
Alzheimer Disease Biological: CAD106 Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : September 2009
Primary Completion Date : June 2011
Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: CAD106 Biological: CAD106


Outcome Measures

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00956410


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT00956410     History of Changes
Other Study ID Numbers: CCAD106A2201E1
First Posted: August 11, 2009    Key Record Dates
Last Update Posted: November 17, 2011
Last Verified: November 2011

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
Neurocognitive Disorders
Mental Disorders