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: NCT00956410
• Other study ID #: CCAD106A2201E1
• Status: Completed
• Phase: Phase 2
• Start date: September 2009
• Est. completion date: June 2011

Study information

• Verified date: November 2011
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will evaluate the safety and tolerability of repeated subcutaneous injections of CAD106 in patients with Alzheimer's disease.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 85 Years

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.

Related Conditions & MeSH terms

• Alzheimer Disease

Intervention

Biological:
• CAD106

Locations

Country	Name	City	State
France	Novartis Investigative Site	Bordeaux
Sweden	Novartis Investigative Site	Stockholm
Switzerland	Novartis Investigative Site	Basel
United Kingdom	Novartis Investigative Site	Southampton

Sponsors (1)

Lead Sponsor	Collaborator
Novartis

Countries where clinical trial is conducted

France,  Sweden,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety/tolerability assessments at multiple timepoints including but not limited to screening, and through to the end of the study to week 66.		66 weeks
Secondary	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.		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
Secondary	Collect long-term safety information through SAEs collection for two years after completion of the core study, CAD106A2201, or extension study, CAD106A2201E1.		2 years

External Links

•   Results for CCAD106A2201E1 on the Novartis Clinical Trial website