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Safety and Tolerability of Repeated Subcutaneous Injections of CAD106 in Mild Alzheimer's Patients.

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00733863
First received: August 8, 2008
Last updated: May 10, 2010
Last verified: May 2010

August 8, 2008
May 10, 2010
July 2008
February 2010   (final data collection date for primary outcome measure)
Safety/tolerability assessments at multiple timepoints including but not limited to screening, baseline, and through the end of the study to Week 52. [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]
Safety/tolerability assessments at multiple timepoints including but not limited to screening, baseline, and through the end of the study to Week 52.
Complete list of historical versions of study NCT00733863 on ClinicalTrials.gov Archive Site
Immune response, cognitive and functional assessments at multiple timepoints including but not limited to baseline and through the end of the study to Week 52. [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
Immune response, cognitive and functional assessments at multiple timepoints including but not limited to baseline and through the end of the study to Week 52.
Not Provided
Not Provided
 
Safety and Tolerability of Repeated Subcutaneous Injections of CAD106 in Mild Alzheimer's Patients.
A 52-week,Multi-center,Randomized,Double-blind,Placebo-controlled,Parallel Group Study in Patients With Mild 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 mild Alzheimer's disease.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Alzheimer Disease
  • Biological: Placebo
  • Biological: CAD106
  • Experimental: 1
    Intervention: Biological: CAD106
  • Placebo Comparator: 2
    Intervention: Biological: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
27
Not Provided
February 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Diagnosis of Mild Alzheimer's Disease
  • Mini-Mental State Examination (MMSE) 20 to 26 at screening, untreated or on stable dose of cholinesterase inhibitor or memantine over the last 6 weeks

Exclusion Criteria:

  • Previously participated in an AD vaccine study and received active treatment
  • History or presence of an active autoimmune and/or with an acute or chronic inflammation, and/or clinically relevant atopic condition.
  • History or presence of seizures and/or cerebrovascular disease.
  • Presence of an other neurodegenerative disease and/or psychiatric disorders (with the exception of successfully treated depression)
Both
40 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
France,   Sweden,   Switzerland,   United Kingdom
 
NCT00733863
CCAD106A2201
Not Provided
External Affairs, Novartis
Novartis
Not Provided
Principal Investigator: Novartis Pharmaceuticals Novartis
Novartis
May 2010

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