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

• ClinicalTrials.gov Identifier: NCT00956410
• Recruitment Status: Completed
• First Posted: August 11, 2009
• Last Update Posted: February 11, 2020
• Sponsor: Novartis
• Information provided by (Responsible Party): Novartis

Tracking Information

• First Submitted Date: August 10, 2009
• First Posted Date: August 11, 2009
• Last Update Posted Date: February 11, 2020
• Study Start Date: September 2009
• Actual Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: August 10, 2009): 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 ]
• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: August 10, 2009)

• 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 ]
• 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 ]
• 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 ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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
• Brief Summary: This study will evaluate the safety and tolerability of repeated subcutaneous injections of CAD106 in patients with Alzheimer's disease.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Non-Randomized; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Alzheimer Disease
• Intervention: 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 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: June 10, 2011): 21
• Original Estimated Enrollment (submitted: August 10, 2009): 27
• Actual Study Completion Date: June 2011
• Actual Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 40 Years to 85 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: France, Sweden, Switzerland, United Kingdom

Administrative Information

• NCT Number: NCT00956410
• Other Study ID Numbers: CCAD106A2201E1
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Novartis
• Original Responsible Party: External Affairs, Novartis
• Current Study Sponsor: Novartis
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Novartis Pharmaceuticals; Novartis Pharmaceuticals

• PRS Account: Novartis
• Verification Date: November 2011