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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis
ClinicalTrials.gov Identifier:
NCT00956410
First received: August 10, 2009
Last updated: November 16, 2011
Last verified: November 2011

August 10, 2009
November 16, 2011
September 2009
June 2011   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00956410 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
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

This study will evaluate the safety and tolerability of repeated subcutaneous injections of CAD106 in patients with Alzheimer's disease.

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Alzheimer Disease
Biological: CAD106
Experimental: CAD106
Intervention: Biological: CAD106
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
21
June 2011
June 2011   (final data collection date for primary outcome measure)

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.
Both
40 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
France,   Sweden,   Switzerland,   United Kingdom
 
NCT00956410
CCAD106A2201E1
Yes
Novartis
Novartis
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP