- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00795418
Safety and Tolerability of Repeated Subcutaneous Injections of CAD 106 in Mild Alzheimer's Patients
December 11, 2020 updated by: Novartis
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
This study will evaluate the safety and tolerability of repeated subcutaneous injections of CAD106 in patients with mid Alzheimer's disease
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
31
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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California
-
Costa Mesa, California, United States, 92626
- ATP Clinical Research
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Colorado
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Boulder, Colorado, United States, 80304
- Alpine Clinical Research Center
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Florida
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Hollywood, Florida, United States, 33021
- Sunrise Clinical Research
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Illinois
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Elk Grove Village, Illinois, United States, 60007
- Alexian Brothers Neuroscience Institute
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Indiana
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Indianapolis, Indiana, United States, 46202
- Indiana University School of Medicine
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Kansas
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Lenexa, Kansas, United States, 66214
- MidAmerica Neuroscience Research Foundation
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New York
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New York, New York, United States, 10032
- Columbia University Medical Center
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19102
- Drexel University College of Medicine
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Tennessee
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Knoxville, Tennessee, United States, 37920
- NOCCR Knoxville
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Texas
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Dallas, Texas, United States, 75390-9139
- University of Texas Southwestern
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years to 85 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
|
Placebo comparator
|
Experimental: CAD106
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
52 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Immune response at multiple timepoints including but not limited to screening, baseline and through the end of the study.
Time Frame: 52 weeks
|
52 weeks
|
Cognitive assessments at multiple timepoints including but not limited to screening, baseline and through the end of the study.
Time Frame: 52 weeks
|
52 weeks
|
Functional assessments at multiple timepoints including but not limited to screening, baseline and through the end of the study.
Time Frame: 52 weeks
|
52 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2008
Primary Completion (Actual)
November 1, 2010
Study Registration Dates
First Submitted
November 10, 2008
First Submitted That Met QC Criteria
November 20, 2008
First Posted (Estimate)
November 21, 2008
Study Record Updates
Last Update Posted (Actual)
December 17, 2020
Last Update Submitted That Met QC Criteria
December 11, 2020
Last Verified
May 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CCAD106A2202
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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