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Safety and Tolerability of Repeated Subcutaneous Injections of CAD 106 in Mild 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: NCT00795418
Recruitment Status : Completed
First Posted : November 21, 2008
Last Update Posted : December 17, 2020
Sponsor:
Information provided by (Responsible Party):
Novartis

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

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

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A 52-week,Multi-center,Randomized,Double-blind,Placebo-controlled,Parallel Group Study in Patients With Mild Alzheimer's Disease to Investigate the Safety and Tolerability of Repeated Subcutaneous Injections of CAD106
Study Start Date : October 2008
Actual Primary Completion Date : November 2010

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: CAD106 Biological: CAD106
Placebo Comparator: Placebo Biological: Placebo
Placebo comparator


Outcome Measures
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Primary Outcome Measures :
  1. Safety/tolerability of repeated injection of CAD106 at multiple timepoints including but not limited to screening, baseline and through the end of the study (adverse events, physical/neurologic exams, vital signs, 12- lead ECGs, clinical labs, brain MRI) [ Time Frame: 52 weeks ]

Secondary Outcome Measures :
  1. Immune response at multiple timepoints including but not limited to screening, baseline and through the end of the study. [ Time Frame: 52 weeks ]
  2. Cognitive assessments at multiple timepoints including but not limited to screening, baseline and through the end of the study. [ Time Frame: 52 weeks ]
  3. Functional assessments at multiple timepoints including but not limited to screening, baseline and through the end of the study. [ Time Frame: 52 weeks ]

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

Inclusion Criteria:

  • Male and/or female patients between 40 and 85 years of age (both inclusive)
  • Diagnosis of mild Alzheimer's Disease (AD)
  • Mini-Mental State Examination (MMSE) 20 to 26 at screening, untreated or on stable dose of cholinesterase inhibitor or memantine over the last 6 weeks.

Exclusion Criteria:

  • Previously participated in an AD vaccine study and received active treatment.
  • History or presence of an active autoimmune and/or with an acute or chronic inflammation, and/or clinically relevant atopic condition.
  • History or presence of seizures and/or cerebrovascular disease.
  • Presence of other neurodegenerative disease and/or psychiatric disorders (with the exception of successfully treated depression)
  • Advanced, severe, progressive or unstable disease that might interfere with the safety of the patient.

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): NCT00795418


Locations
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United States, California
ATP Clinical Research
Costa Mesa, California, United States, 92626
United States, Colorado
Alpine Clinical Research Center
Boulder, Colorado, United States, 80304
United States, Florida
Sunrise Clinical Research
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, Kansas
MidAmerica NeuroScience Research Foundation
Lenexa, Kansas, United States, 66214
United States, New York
Columbia University Medical Center
New York, New York, United States, 10032
United States, Pennsylvania
Drexel University College of Medicine
Philadelphia, Pennsylvania, United States, 19102
United States, Tennessee
NOCCR Knoxville
Knoxville, Tennessee, United States, 37920
United States, Texas
University of Texas Southwestern
Dallas, Texas, United States, 75390-9139
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: NCT00795418    
Other Study ID Numbers: CCAD106A2202
First Posted: November 21, 2008    Key Record Dates
Last Update Posted: December 17, 2020
Last Verified: May 2012
Keywords provided by Novartis:
Active immunization
Alzheimer's disease
Antibody
 Vaccine
Central Nervous System Diseases
Neurodegenerative diseases
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