To Investigate the Safety and Tolerability of Repeated Subcutaneous Injections of CAD106 in Alzheimer's Patients
Primary Purpose
Alzheimer Disease
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
CAD106
Sponsored by
About this trial
This is an interventional treatment trial for Alzheimer Disease focused on measuring Active immunization, Alzheimer disease, Antibody, Central Nervous System diseases, Neurodegenerative diseases, Vaccine
Eligibility 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
Sites / Locations
- ATP Clinical Research, Inc.
- Alpin Research Center
- Sunrise Clinical Research, Inc.
- Alexian Brothers Neuroscience Institute
- Indiana University School of Medicine
- Drexel University College of Medicine
- Volunteer Research Group
- University of Texas Southwestern
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
CAD106
Arm Description
Outcomes
Primary Outcome Measures
Safety/tolerability assessments at multiple time points including but not limited to screening, and through to the end of the study to week 66.
Secondary Outcome Measures
Collect long-term safety information through SAE's collection for two years after completion of the extension study.
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.
Evaluate the antibody response after 4 additional injections in the Extension study, in patients initially treated with CAD106 in the Core study.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01023685
Brief Title
To Investigate the Safety and Tolerability of Repeated Subcutaneous Injections of CAD106 in Alzheimer's Patients
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 Type
Interventional
2. Study Status
Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
December 2009 (undefined)
Primary Completion Date
February 2012 (Actual)
Study Completion Date
February 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis
4. Oversight
5. Study Description
Brief Summary
This study will investigate the Safety and Tolerability of Repeated Subcutaneous Injections of CAD106 in Alzheimer's Patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease
Keywords
Active immunization, Alzheimer disease, Antibody, Central Nervous System diseases, Neurodegenerative diseases, Vaccine
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CAD106
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
CAD106
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Collect long-term safety information through SAE's collection for two years after completion of the extension study.
Time Frame
2 years
Title
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
Title
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
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
ATP Clinical Research, Inc.
City
Costa Mesa
State/Province
California
ZIP/Postal Code
92626
Country
United States
Facility Name
Alpin Research Center
City
Boulder
State/Province
Colorado
ZIP/Postal Code
80304
Country
United States
Facility Name
Sunrise Clinical Research, Inc.
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33021
Country
United States
Facility Name
Alexian Brothers Neuroscience Institute
City
Elk Grove Village
State/Province
Illinois
ZIP/Postal Code
60007
Country
United States
Facility Name
Indiana University School of Medicine
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Drexel University College of Medicine
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19102
Country
United States
Facility Name
Volunteer Research Group
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37920
Country
United States
Facility Name
University of Texas Southwestern
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
25918556
Citation
Farlow MR, Andreasen N, Riviere ME, Vostiar I, Vitaliti A, Sovago J, Caputo A, Winblad B, Graf A. Long-term treatment with active Abeta 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.
Results Reference
derived
Links:
URL
https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=8123
Description
Results for CCAD106A2202E1 from the Novartis Clinical Trials website
Learn more about this trial
To Investigate the Safety and Tolerability of Repeated Subcutaneous Injections of CAD106 in Alzheimer's Patients
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