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

NCT00956410

Collaborator

(none)

Enrollment

Locations

Arm

Duration (Months)

5.3

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

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

Study Design

Study Type:

Interventional

Actual Enrollment :

21 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 :

Sep 1, 2009

Actual Primary Completion Date :

Jun 1, 2011

Actual Study Completion Date :

Jun 1, 2011

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 timepoints including but not limited to screening, and through to the end of the study to week 66. [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. [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]
Collect long-term safety information through SAEs collection for two years after completion of the core study, CAD106A2201, or extension study, CAD106A2201E1. [2 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 85 Years

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.

Contacts and Locations

Locations

	Site	City	Country
1	Novartis Investigative Site	Bordeaux	France
2	Novartis Investigative Site	Stockholm	Sweden
3	Novartis Investigative Site	Basel	Switzerland
4	Novartis Investigative Site	Southampton	United Kingdom