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Safety and Tolerability of Repeated Subcutaneous Injections of CAD 106 in Mild Alzheimer's Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis
ClinicalTrials.gov Identifier:
NCT00795418
First received: November 10, 2008
Last updated: May 2, 2012
Last verified: May 2012
November 10, 2008
May 2, 2012
October 2008
November 2010   (Final data collection date for primary outcome measure)
Safety/tolerability of repeated injection of CAD106 at multiple timepoints including but not limited to screening, baseline and through the end of the study (adverse events, physical/neurologic exams, vital signs, 12- lead ECGs, clinical labs, brain MRI) [ Time Frame: 52 weeks ]
Same as current
Complete list of historical versions of study NCT00795418 on ClinicalTrials.gov Archive Site
  • Immune response at multiple timepoints including but not limited to screening, baseline and through the end of the study. [ Time Frame: 52 weeks ]
  • Cognitive assessments at multiple timepoints including but not limited to screening, baseline and through the end of the study. [ Time Frame: 52 weeks ]
  • Functional assessments at multiple timepoints including but not limited to screening, baseline and through the end of the study. [ Time Frame: 52 weeks ]
Same as current
Not Provided
Not Provided
 
Safety and Tolerability of Repeated Subcutaneous Injections of CAD 106 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 mid Alzheimer's disease
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Alzheimer's Disease
  • Biological: Placebo
    Placebo comparator
  • Biological: CAD106
  • Experimental: CAD106
    Intervention: Biological: CAD106
  • Placebo Comparator: Placebo
    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
31
Not Provided
November 2010   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Male and/or female patients between 40 and 85 years of age (both inclusive)
  • Diagnosis of mild Alzheimer's Disease (AD)
  • 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 other neurodegenerative disease and/or psychiatric disorders (with the exception of successfully treated depression)
  • Advanced, severe, progressive or unstable disease that might interfere with the safety of the patient.

Other protocol-defined inclusion/exclusion criteria may apply

Sexes Eligible for Study: All
40 Years to 85 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00795418
CCAD106A2202
Not Provided
Not Provided
Not Provided
Novartis
Novartis
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
May 2012

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