Safety and Tolerability of Repeated Subcutaneous Injections of CAD 106 in Mild Alzheimer's Patients - Full Text View

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00795418

Purpose

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

Condition	Intervention	Phase
Alzheimer's Disease	Biological: Placebo Biological: CAD106	Phase II

Genetics Home Reference related topics: Alzheimer disease

MedlinePlus related topics: Alzheimer's Disease Coronary Artery Disease Neurologic Diseases

Drug Information available for: Immunoglobulins Globulin, Immune

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment
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

Further study details as provided by Novartis:

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) [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Immune response at multiple timepoints including but not limited to screening, baseline and through the end of the study. [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
Cognitive assessments at multiple timepoints including but not limited to screening, baseline and through the end of the study. [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
Functional assessments at multiple timepoints including but not limited to screening, baseline and through the end of the study. [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	30
Study Start Date:	October 2008
Estimated Primary Completion Date:	March 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Placebo Comparator	Biological: Placebo Placebo comparator
2: Experimental	Biological: CAD106 Repeated subcutaneous injections of CAD106

Eligibility

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00795418

Contacts

Contact: Novartis Pharmaceuticals

862-778-8300

Locations

United States, California
University of California	Not yet recruiting
San Francisco, California, United States, 94143
Contact: Adam Boxer, MD 415-476-0661 adam.boxer@memory.ucsf.edu
United States, Indiana
Indiana University School of Medicine	Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Martin Farlow 317-826-8491 mfarlow@iupui.edu
United States, Massachusetts
Brigham and Women's Hospital	Not yet recruiting
Boston, Massachusetts, United States, 02115
Contact: Gad Marshall, MD 617-525-8383 GAMARSHALL@PARTNERS.ORG
United States, New York
Columbia University Medical Center	Not yet recruiting
New York, New York, United States, 10032
Contact: Karen Bell, MD 212-305-2077 KLB1@columbia.edu
United States, Pennsylvania
Drexel University College of Medicine	Not yet recruiting
Philadelphia, Pennsylvania, United States, 19102
Contact: Carol Lippa, MD 215-925-1447 clippa@drexelmed.edu
United States, Texas
University of Texas Southwestern	Not yet recruiting
Dallas, Texas, United States, 75390
Contact: Marion Weiner, MD 214-648-9353 myron.weiner@utsouthwestern.edu

Sponsors and Collaborators

Novartis

Investigators

Study Director:

Novartis Pharmaceuticals

More Information

Responsible Party:	Novartis Pharmaceuticals ( External Affairs )
Study ID Numbers:	CCAD106A2202
Study First Received:	November 10, 2008
Last Updated:	November 20, 2008
ClinicalTrials.gov Identifier:	NCT00795418
Health Authority:	United States: Food and Drug Administration

Keywords provided by Novartis:

Active immunization
Alzheimer's disease
Antibody
Vaccine

Central Nervous System Diseases
Neurodegenerative diseases
Vaccine

Study placed in the following topic categories:

Antibodies
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Alzheimer Disease
Central Nervous System Diseases
Brain Diseases

Dementia
Neurodegenerative Diseases
Cognition Disorders
Coronary Artery Disease
Immunoglobulins
Delirium

Additional relevant MeSH terms:

Nervous System Diseases
Tauopathies

ClinicalTrials.gov processed this record on January 14, 2009