Trial record 1 of 1 for:
NCT00795418
Safety and Tolerability of Repeated Subcutaneous Injections of CAD 106 in Mild Alzheimer's Patients
This study has been completed.
Sponsor:
Novartis
Information provided by (Responsible Party):
Novartis
ClinicalTrials.gov Identifier:
NCT00795418
First received: November 10, 2008
Last updated: May 2, 2012
Last verified: May 2012
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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 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, 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 |
Resource links provided by NLM:
Genetics Home Reference related topics:
Alzheimer disease
MedlinePlus related topics:
Alzheimer's Disease
Coronary Artery Disease
Degenerative Nerve Diseases
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 ]
| Enrollment: | 31 |
| Study Start Date: | October 2008 |
| Primary Completion Date: | November 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: CAD106 | Biological: CAD106 |
| Placebo Comparator: Placebo |
Biological: Placebo
Placebo comparator
|
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 | |
| 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
| Study Director: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
More Information
No publications provided
| Responsible Party: | Novartis |
| ClinicalTrials.gov Identifier: | NCT00795418 History of Changes |
| Other Study ID Numbers: | CCAD106A2202 |
| Study First Received: | November 10, 2008 |
| Last Updated: | May 2, 2012 |
| 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 |
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 22, 2013