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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Experimental: CAD106	Biological: CAD106

Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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, 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.

Other protocol-defined inclusion/exclusion criteria may apply

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Farlow MR, Andreasen N, Riviere ME, Vostiar I, Vitaliti A, Sovago J, Caputo A, Winblad B, Graf A. Long-term treatment with active Aβ immunotherapy with CAD106 in mild Alzheimer's disease. Alzheimers Res Ther. 2015 Apr 27;7(1):23. doi: 10.1186/s13195-015-0108-3. eCollection 2015.

Responsible Party:	Novartis
ClinicalTrials.gov Identifier:	NCT01023685 History of Changes
Other Study ID Numbers:	CCAD106A2202E1
First Posted:	December 2, 2009
Last Update Posted:	June 26, 2013
Last Verified:	June 2013

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