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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00733863
First Posted: August 13, 2008
Last Update Posted: May 12, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Novartis
August 8, 2008
August 13, 2008
May 12, 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 ]
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 ]
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
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Alzheimer Disease
  • Biological: Placebo
  • Biological: CAD106
  • Experimental: 1
    Intervention: Biological: CAD106
  • Placebo Comparator: 2
    Intervention: Biological: Placebo
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.
 
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)
Sexes Eligible for Study: All
40 Years to 85 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
France,   Sweden,   Switzerland,   United Kingdom
 
 
NCT00733863
CCAD106A2201
Not Provided
Not Provided
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