Safety and Tolerability of Repeated Subcutaneous Injections of CAD 106 in Mild Alzheimer's Patients

Sponsor

Novartis (Industry)

Overall Status

Completed

CT.gov ID

NCT00795418

Collaborator

(none)

Enrollment

Locations

Arms

3.1

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 mid Alzheimer's disease

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

Study Design

Study Type:

Interventional

Actual Enrollment :

31 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 :

Oct 1, 2008

Actual Primary Completion Date :

Nov 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: CAD106	Biological: CAD106
Placebo Comparator: Placebo	Biological: Placebo Placebo comparator

Arm

Intervention/Treatment

Experimental: CAD106

Biological: CAD106

Placebo Comparator: Placebo

Biological: Placebo

Placebo comparator

Outcome Measures

Primary Outcome Measures

Safety/tolerability of repeated injection of CAD106 at multiple timepoints including but not limited to screening, baseline and through the end of the study (adverse events, physical/neurologic exams, vital signs, 12- lead ECGs, clinical labs, brain MRI) [52 weeks]

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Male and/or female patients between 40 and 85 years of age (both inclusive)
Diagnosis of mild Alzheimer's Disease (AD)
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 other neurodegenerative disease and/or psychiatric disorders (with the exception of successfully treated depression)
Advanced, severe, progressive or unstable disease that might interfere with the safety of the patient.

Other protocol-defined inclusion/exclusion criteria may apply

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	ATP Clinical Research	Costa Mesa	California	United States	92626
2	Alpine Clinical Research Center	Boulder	Colorado	United States	80304
3	Sunrise Clinical Research	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	MidAmerica NeuroScience Research Foundation	Lenexa	Kansas	United States	66214
7	Columbia University Medical Center	New York	New York	United States	10032
8	Drexel University College of Medicine	Philadelphia	Pennsylvania	United States	19102
9	NOCCR Knoxville	Knoxville	Tennessee	United States	37920
10	University of Texas Southwestern	Dallas	Texas	United States	75390-9139