Safety and Tolerability of Repeated Subcutaneous Injections of CAD106 in Mild Alzheimer's Patients.

Sponsor

Novartis (Industry)

Overall Status

Completed

CT.gov ID

NCT00733863

Collaborator

(none)

Enrollment

Locations

Arms

6.8

Patients Per Site

Study Details

Study Description

Brief Summary

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

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

Study Design

Study Type:

Interventional

Actual Enrollment :

27 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

A 52-week,Multi-center,Randomized,Double-blind,Placebo-controlled,Parallel Group Study in Patients With Mild Alzheimer's Disease to Investigate the Safety and Tolerability of Repeated Subcutaneous Injections of CAD106

Study Start Date :

Jul 1, 2008

Actual Primary Completion Date :

Feb 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1	Biological: CAD106
Placebo Comparator: 2	Biological: Placebo

Arm

Intervention/Treatment

Experimental: 1

Biological: CAD106

Placebo Comparator: 2

Biological: Placebo

Outcome Measures

Primary Outcome Measures

Safety/tolerability assessments at multiple timepoints including but not limited to screening, baseline, and through the end of the study to Week 52. [52 weeks]

Secondary Outcome Measures

Immune response, cognitive and functional assessments at multiple timepoints including but not limited to baseline and through the end of the study to Week 52. [52 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Diagnosis of Mild Alzheimer's Disease
Mini-Mental State Examination (MMSE) 20 to 26 at screening, untreated or on stable dose of cholinesterase inhibitor or memantine over the last 6 weeks

Exclusion Criteria:

Previously participated in an AD vaccine study and received active treatment
History or presence of an active autoimmune and/or with an acute or chronic inflammation, and/or clinically relevant atopic condition.
History or presence of seizures and/or cerebrovascular disease.
Presence of an other neurodegenerative disease and/or psychiatric disorders (with the exception of successfully treated depression)

Contacts and Locations

Locations

	Site	City	Country
1	Centre Hospitalier Universitaire Pellegrin	Bordeaux	France
2	Karolinska Universitetssjukhuset Huddinge	Stockholm	Sweden
3	NeuroPsychologieZentrum	Basel	Switzerland
4	Moorgreen Hospital	Southampton	United Kingdom