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

This study has been completed.

Sponsor:

Information provided by:

Novartis

ClinicalTrials.gov Identifier:

NCT00733863

First received: August 8, 2008

Last updated: May 10, 2010

Last verified: May 2010

History of Changes

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 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety Study 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

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

U.S. FDA Resources

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
Primary Completion Date:	February 2010 (Final data collection date for primary outcome measure)

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

Eligibility

Ages Eligible for Study:	40 Years to 85 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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:	External Affairs, Novartis
ClinicalTrials.gov Identifier:	NCT00733863 History of Changes
Other Study ID Numbers:	CCAD106A2201
Study First Received:	August 8, 2008
Last Updated:	May 10, 2010
Health Authority:	Switzerland: Swissmedic

Keywords provided by Novartis:

Active immunization
Alzheimer disease
Antibody

Central Nervous System Diseases
Neurodegenerative diseases
Vaccine

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 June 18, 2013

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