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

Alzheimer Disease Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01023685
• Other study ID #: CCAD106A2202E1
• Status: Completed
• Phase: Phase 2
• Start date: December 2009
• Est. completion date: February 2012

Study information

• Verified date: June 2013
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will investigate the Safety and Tolerability of Repeated Subcutaneous Injections of CAD106 in Alzheimer's Patients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: February 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Other protocol-defined inclusion/exclusion criteria may apply

Related Conditions & MeSH terms

• Alzheimer Disease

Intervention

Biological:
• CAD106

Locations

Country	Name	City	State
United States	Alpin Research Center	Boulder	Colorado
United States	ATP Clinical Research, Inc.	Costa Mesa	California
United States	University of Texas Southwestern	Dallas	Texas
United States	Alexian Brothers Neuroscience Institute	Elk Grove Village	Illinois
United States	Sunrise Clinical Research, Inc.	Hollywood	Florida
United States	Indiana University School of Medicine	Indianapolis	Indiana
United States	Volunteer Research Group	Knoxville	Tennessee
United States	Drexel University College of Medicine	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Novartis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety/tolerability assessments at multiple time points including but not limited to screening, and through to the end of the study to week 66.		66 weeks
Secondary	Collect long-term safety information through SAE's collection for two years after completion of the extension study.		2 years
Secondary	Immune response, cognitive and functional assessments at multiple time points including but not limited to baseline, and through to the end of the study to week 66.		66 weeks
Secondary	Evaluate the antibody response after 4 additional injections in the Extension study, in patients initially treated with CAD106 in the Core study.		66 weeks

External Links

•   Results for CCAD106A2202E1 from the Novartis Clinical Trials website