We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00956410
First Posted: August 11, 2009
Last Update Posted: November 17, 2011
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 (Responsible Party):
Novartis
  Purpose
This study will evaluate the safety and tolerability of repeated subcutaneous injections of CAD106 in patients with Alzheimer's disease.

Condition Intervention Phase
Alzheimer Disease Biological: CAD106 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 21
Study Start Date: September 2009
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CAD106 Biological: CAD106

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   40 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00956410


Locations
France
Novartis Investigative Site
Bordeaux, France
Sweden
Novartis Investigative Site
Stockholm, Sweden
Switzerland
Novartis Investigative Site
Basel, Switzerland
United Kingdom
Novartis Investigative Site
Southampton, United Kingdom
Sponsors and Collaborators
Novartis
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT00956410     History of Changes
Other Study ID Numbers: CCAD106A2201E1
First Submitted: August 10, 2009
First Posted: August 11, 2009
Last Update Posted: November 17, 2011
Last Verified: November 2011

Keywords provided by Novartis:
Active immunization
Alzheimer disease
Antibody
Central Nervous System Diseases
Neurodegenerative diseases
Vaccine

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders