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

Sponsor

Novartis (Industry)

Overall Status

Completed

CT.gov ID

NCT01023685

Collaborator

(none)

Enrollment

Locations

Arm

Duration (Months)

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Alzheimer Disease	Biological: CAD106	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

24 participants

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.

Study Start Date :

Dec 1, 2009

Actual Primary Completion Date :

Feb 1, 2012

Actual Study Completion Date :

Feb 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: CAD106	Biological: CAD106

Arm

Intervention/Treatment

Experimental: CAD106

Biological: CAD106

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

Collect long-term safety information through SAE's collection for two years after completion of the extension study. [2 years]
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]
Evaluate the antibody response after 4 additional injections in the Extension study, in patients initially treated with CAD106 in the Core study. [66 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	ATP Clinical Research, Inc.	Costa Mesa	California	United States	92626
2	Alpin Research Center	Boulder	Colorado	United States	80304
3	Sunrise Clinical Research, Inc.	Hollywood	Florida	United States	33021
4	Alexian Brothers Neuroscience Institute	Elk Grove Village	Illinois	United States	60007
5	Indiana University School of Medicine	Indianapolis	Indiana	United States	46202
6	Drexel University College of Medicine	Philadelphia	Pennsylvania	United States	19102
7	Volunteer Research Group	Knoxville	Tennessee	United States	37920
8	University of Texas Southwestern	Dallas	Texas	United States	75390