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

Sponsor:	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

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:

Genetics Home Reference related topics: Alzheimer disease

U.S. FDA Resources

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 ]

Enrollment:	31
Study Start Date:	October 2008
Primary Completion Date:	November 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: CAD106	Biological: CAD106
Placebo Comparator: Placebo	Biological: Placebo Placebo comparator

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

Locations

United States, California
ATP Clinical Research
Costa Mesa, California, United States, 92626
United States, Colorado
Alpine Clinical Research Center
Boulder, Colorado, United States, 80304
United States, Florida
Sunrise Clinical Research
Hollywood, Florida, United States, 33021
United States, Illinois
Alexian Brothers Neuroscience Institute
Elk Grove Village, Illinois, United States, 60007
United States, Indiana
Indiana University School of Medicine
Indianapolis, Indiana, United States, 46202
United States, Kansas
MidAmerica NeuroScience Research Foundation
Lenexa, Kansas, United States, 66214
United States, New York
Columbia University Medical Center
New York, New York, United States, 10032
United States, Pennsylvania
Drexel University College of Medicine
Philadelphia, Pennsylvania, United States, 19102
United States, Tennessee
NOCCR Knoxville
Knoxville, Tennessee, United States, 37920
United States, Texas
University of Texas Southwestern
Dallas, Texas, United States, 75390-9139

Sponsors and Collaborators

Novartis

Investigators

Study Director:

Novartis Pharmaceuticals

More Information

No publications provided

Responsible Party:	External Affairs, Novartis Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00795418 History of Changes
Other Study ID Numbers:	CCAD106A2202
Study First Received:	November 10, 2008
Last Updated:	December 16, 2010
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

Additional relevant MeSH terms:

Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on February 02, 2012