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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: NCT01023685
Recruitment Status : Completed
First Posted : December 2, 2009
Last Update Posted : December 17, 2020
Sponsor:
Information provided by (Responsible Party):
Novartis

Study Description
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Brief Summary:
This study will investigate the Safety and Tolerability of Repeated Subcutaneous Injections of CAD106 in Alzheimer's Patients.

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

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 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 : December 2009
Actual Primary Completion Date : February 2012
Actual Study Completion Date : February 2012

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Arms and Interventions
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Arm Intervention/treatment
Experimental: CAD106 Biological: CAD106


Outcome Measures
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Primary Outcome Measures :
  1. Safety/tolerability assessments at multiple time points 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. Collect long-term safety information through SAE's collection for two years after completion of the extension study. [ Time Frame: 2 years ]
  2. Immune response, cognitive and functional assessments at multiple time points including but not limited to baseline, and through to the end of the study to week 66. [ Time Frame: 66 weeks ]
  3. 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 ]

Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
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.

Other protocol-defined inclusion/exclusion criteria may apply

Contacts and Locations
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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): NCT01023685


Locations
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United States, California
ATP Clinical Research, Inc.
Costa Mesa, California, United States, 92626
United States, Colorado
Alpin Research Center
Boulder, Colorado, United States, 80304
United States, Florida
Sunrise Clinical Research, Inc.
Hollywood, Florida, United States, 33021
United States, Illinois
Alexian Brothers Neuroscience Institute
Elk Grove Village, Illinois, United States, 60007
United States, Indiana
Indiana University School of Medicine
Indianapolis, Indiana, United States, 46202
United States, Pennsylvania
Drexel University College of Medicine
Philadelphia, Pennsylvania, United States, 19102
United States, Tennessee
Volunteer Research Group
Knoxville, Tennessee, United States, 37920
United States, Texas
University of Texas Southwestern
Dallas, Texas, United States, 75390
Sponsors and Collaborators
Novartis
Investigators
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT01023685    
Other Study ID Numbers: CCAD106A2202E1
First Posted: December 2, 2009    Key Record Dates
Last Update Posted: December 17, 2020
Last Verified: June 2013
Keywords provided by Novartis:
Active immunization
Alzheimer disease
Antibody
 Central Nervous System diseases
Neurodegenerative diseases
Vaccine
Additional relevant MeSH terms:
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Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders