Back to resultsTo 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
International
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.
Sites / Locations
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
CAD106
Arm Description
Outcomes
Primary Outcome Measures
Safety/tolerability assessments at multiple timepoints including but not limited to screening, and through to the end of the study to week 66.
Secondary Outcome Measures
Immune response, cognitive and functional assessments at multiple timepoints 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.
Collect long-term safety information through SAEs collection for two years after completion of the core study, CAD106A2201, or extension study, CAD106A2201E1.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00956410
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
November 2011
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
June 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study will evaluate the safety and tolerability of repeated subcutaneous injections of CAD106 in patients with Alzheimer's disease.
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
21 (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 timepoints 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
Immune response, cognitive and functional assessments at multiple timepoints 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
Title
Collect long-term safety information through SAEs collection for two years after completion of the core study, CAD106A2201, or extension study, CAD106A2201E1.
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
85 Years
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.
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
Novartis Investigative Site
City
Bordeaux
Country
France
Facility Name
Novartis Investigative Site
City
Stockholm
Country
Sweden
Facility Name
Novartis Investigative Site
City
Basel
Country
Switzerland
Facility Name
Novartis Investigative Site
City
Southampton
Country
United Kingdom
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
Learn more about this trial
To Investigate the Safety and Tolerability of Repeated Subcutaneous Injections of CAD106 in Alzheimer's Patients
We'll reach out to this number within 24 hrs