To Investigate the Safety and Tolerability of Repeated Subcutaneous Injections of CAD106 in Alzheimer's Patients

Tracking Information
First Submitted Date ICMJE	December 1, 2009
First Posted Date ICMJE	December 2, 2009
Last Update Posted Date	June 26, 2013
Study Start Date ICMJE	December 2009
Actual Primary Completion Date	February 2012 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: December 1, 2009)	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 ]
Original Primary Outcome Measures ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01023685 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: December 1, 2009)	Collect long-term safety information through SAE's collection for two years after completion of the extension study. [ Time Frame: 2 years ]; 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 ]; 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 ]
Original Secondary Outcome Measures ICMJE	Same as current
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	To Investigate the Safety and Tolerability of Repeated Subcutaneous Injections of CAD106 in Alzheimer's Patients
Official Title ICMJE	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.
Brief Summary	This study will investigate the Safety and Tolerability of Repeated Subcutaneous Injections of CAD106 in Alzheimer's Patients.
Detailed Description	Not Provided
Study Type ICMJE	Interventional
Study Phase	Phase 2
Study Design ICMJE	Allocation: Non-Randomized; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Condition ICMJE	Alzheimer Disease
Intervention ICMJE	Biological: CAD106
Study Arms	Experimental: CAD106; Intervention: Biological: CAD106
Publications *	Farlow MR, Andreasen N, Riviere ME, Vostiar I, Vitaliti A, Sovago J, Caputo A, Winblad B, Graf A. Long-term treatment with active Aβ 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.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: June 10, 2011)	24
Original Estimated Enrollment ICMJE; (submitted: December 1, 2009)	30
Actual Study Completion Date	February 2012
Actual Primary Completion Date	February 2012 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	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
Sex/Gender	Sexes Eligible for Study: All
Ages	Child, Adult, Senior
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	United States
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT01023685
Other Study ID Numbers ICMJE	CCAD106A2202E1
Has Data Monitoring Committee	Not Provided
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Novartis
Study Sponsor ICMJE	Novartis
Collaborators ICMJE	Not Provided
Investigators ICMJE	Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
PRS Account	Novartis
Verification Date	June 2013
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP