To Investigate the Safety and Tolerability of Repeated Subcutaneous Injections of CAD106 in Alzheimer's Patients
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
1 other identifier
interventional
21
4 countries
4
Brief Summary
This study will evaluate the safety and tolerability of repeated subcutaneous injections of CAD106 in patients with Alzheimer's disease.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2 alzheimer-disease
Started Sep 2009
Shorter than P25 for phase_2 alzheimer-disease
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 10, 2009
CompletedFirst Posted
Study publicly available on registry
August 11, 2009
CompletedStudy Start
First participant enrolled
September 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2011
CompletedFebruary 11, 2020
November 1, 2011
1.7 years
August 10, 2009
February 8, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Safety/tolerability assessments at multiple timepoints including but not limited to screening, and through to the end of the study to week 66.
66 weeks
Secondary Outcomes (3)
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.
66 weeks
Evaluate the antibody response after 4 additional injections in the Extension study in patients initially treated with CAD106 in the Core study.
66 weeks
Collect long-term safety information through SAEs collection for two years after completion of the core study, CAD106A2201, or extension study, CAD106A2201E1.
2 years
Study Arms (1)
CAD106
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Patients who have completed the Core study with no significant safety concerns
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novartislead
Study Sites (4)
Novartis Investigative Site
Bordeaux, France
Novartis Investigative Site
Stockholm, Sweden
Novartis Investigative Site
Basel, Switzerland
Novartis Investigative Site
Southampton, United Kingdom
Related Publications (1)
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.
PMID: 25918556DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 10, 2009
First Posted
August 11, 2009
Study Start
September 1, 2009
Primary Completion
June 1, 2011
Study Completion
June 1, 2011
Last Updated
February 11, 2020
Record last verified: 2011-11