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Safety and Tolerability of Repeated Subcutaneous Injections of CAD 106 in Mild Alzheimer's Patients
This study is ongoing, but not recruiting participants.
First Received: November 10, 2008   Last Updated: November 23, 2009   History of Changes
Sponsor: Novartis
Information provided by: Novartis
ClinicalTrials.gov Identifier: NCT00795418
  Purpose

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


Condition Intervention Phase
Alzheimer's Disease
 Biological: Placebo
Biological: CAD106
 Phase II

Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment
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

Resource links provided by NLM:

Genetics Home Reference related topics: Alzheimer disease
MedlinePlus related topics: Alzheimer's Disease Neurologic Diseases
U.S. FDA Resources

Further study details as provided by Novartis:

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

Secondary Outcome Measures:
  • Immune response at multiple timepoints including but not limited to screening, baseline and through the end of the study. [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • Cognitive assessments at multiple timepoints including but not limited to screening, baseline and through the end of the study. [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • Functional assessments at multiple timepoints including but not limited to screening, baseline and through the end of the study. [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: October 2008
Estimated Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Placebo Comparator Biological: Placebo
Placebo comparator
2: Experimental Biological: CAD106
Repeated subcutaneous injections of CAD106

  Eligibility

Ages Eligible for Study:   40 Years to 85 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00795418

Locations
United States, California
University of California
San Francisco, California, United States, 94143
ATP Clinical Research
Costa Mesa, California, United States, 92626
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
Dr Winegarner
Lenexa, Kansas, United States, 66214
United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
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
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis Pharmaceuticals ( External Affairs )
Study ID Numbers: CCAD106A2202
Study First Received: November 10, 2008
Last Updated: November 23, 2009
ClinicalTrials.gov Identifier: NCT00795418     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by Novartis:
Active immunization
Alzheimer's disease
Antibody
Vaccine
 Central Nervous System Diseases
Neurodegenerative diseases
Vaccine

Additional relevant MeSH terms:
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Nervous System Diseases
Alzheimer Disease
Central Nervous System Diseases
 Neurodegenerative Diseases
Tauopathies
Brain Diseases
Dementia

ClinicalTrials.gov processed this record on February 04, 2010



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