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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis
ClinicalTrials.gov Identifier:
NCT01023685
First received: December 1, 2009
Last updated: July 17, 2012
Last verified: July 2012
History of Changes
  Purpose

This study will investigate the Safety and Tolerability of Repeated Subcutaneous Injections of CAD106 in Alzheimer's Patients.


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:

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Collect long-term safety information through SAE's collection for two years after completion of the extension study. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • 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 ] [ 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 ]

Enrollment: 24
Study Start Date: December 2009
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CAD106 Biological: CAD106

  Eligibility

Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01023685

Locations
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
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT01023685     History of Changes
Other Study ID Numbers: CCAD106A2202E1
Study First Received: December 1, 2009
Last Updated: July 17, 2012
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on May 16, 2013