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

This study is ongoing, but not recruiting participants.

First Received: August 8, 2008 Last Updated: March 31, 2009 History of Changes

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00733863

Purpose

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

Condition	Intervention	Phase
Alzheimer 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

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety Study
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 assessments at multiple timepoints including but not limited to screening, baseline, and through the end of the study to Week 52. [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]

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. [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]

Enrollment:	27
Study Start Date:	July 2008
Estimated Primary Completion Date:	January 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Biological: CAD106
2: Placebo Comparator	Biological: Placebo

Eligibility

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00733863

Locations

France
Centre Hospitalier Universitaire Pellegrin
Bordeaux, France
Sweden
Karolinska Universitetssjukhuset Huddinge
Stockholm, Sweden
Switzerland
NeuroPsychologieZentrum
Basel, Switzerland
United Kingdom
Moorgreen Hospital
Southampton, United Kingdom

Sponsors and Collaborators

Novartis

Investigators

Principal Investigator:

Novartis Pharmaceuticals

Novartis

More Information

No publications provided

Responsible Party:	Novartis ( External Affairs )
Study ID Numbers:	CCAD106A2201
Study First Received:	August 8, 2008
Last Updated:	March 31, 2009
ClinicalTrials.gov Identifier:	NCT00733863 History of Changes
Health Authority:	Switzerland: Swissmedic

Keywords provided by Novartis:

Active immunization
Alzheimer disease
Antibody

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:

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

Neurodegenerative Diseases
Tauopathies
Brain Diseases
Dementia

ClinicalTrials.gov processed this record on May 07, 2009