OmegAD (Omega-3 and Alzheimer's Disease)

This study has been completed.

Sponsor:

Information provided by:

Karolinska University Hospital

ClinicalTrials.gov Identifier:

NCT00211159

First received: September 13, 2005

Last updated: February 7, 2007

Last verified: April 2005

History of Changes

Purpose

Memory loss and difficulties with thinking associated with Alzheimer's disease (AD) may be due to a deficiency in the brain of a fatty acid named DHA. The aim of this trial is to see if dietary supplementation with a preparation, rich in DHA, will halt cognitive impairment in AD patients

Condition	Intervention
Alzheimer's Disease	Drug: EPAX 1050TG

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double-Blind Primary Purpose: Treatment
Official Title:	Omega-3 Fatty Acid Treatment of 174 Patients With Mild to Moderate Alzheimer's Disease (OmegAD): a Randomized Double-Blind Trial

Resource links provided by NLM:

Genetics Home Reference related topics: Alzheimer disease

MedlinePlus related topics: Alzheimer's Disease

Drug Information available for: Omega-3 Fatty Acids

U.S. FDA Resources

Further study details as provided by Karolinska University Hospital:

Primary Outcome Measures:

Cognition measured according to ADAS-cog, MMSE scales

Secondary Outcome Measures:

Safety, tolerability, blood pressure

Estimated Enrollment:	204
Study Start Date:	December 2000

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria: Alzheimer's disease with MMSE 15-30, living in own homes, treated with stable dose of acetylcholine esterase inhibitor for >3 months and remaining on that treatment for the study period

Exclusion Criteria: Already treated with omega-3 fatty acids, NSAIDs, warfarin, being an alcohol abuser, suffering from serious concomitant disease or not having a caregiver

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00211159

Locations

Sweden
Karolinska University Hospital Huddinge
Stockholm, Sweden, S-141 86

Sponsors and Collaborators

Karolinska University Hospital

Investigators

Principal Investigator:

Tommy Cederholm, MD, PhD

Karolinska University Hospital

More Information

Publications:

Freund-Levi Y, Eriksdotter-Jonhagen M, Cederholm T, Basun H, Faxen-Irving G, Garlind A, Vedin I, Vessby B, Wahlund LO, Palmblad J. Omega-3 fatty acid treatment in 174 patients with mild to moderate Alzheimer disease: OmegAD study: a randomized double-blind trial. Arch Neurol. 2006 Oct;63(10):1402-8.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Vedin I, Cederholm T, Freund-Levi Y, Basun H, Garlind A, Irving GF, Eriksdotter-Jönhagen M, Wahlund LO, Dahlman I, Palmblad J. Effects of DHA-rich n-3 fatty acid supplementation on gene expression in blood mononuclear leukocytes: the OmegAD study. PLoS One. 2012;7(4):e35425. Epub 2012 Apr 24.

Vedin I, Cederholm T, Freund-Levi Y, Basun H, Hjorth E, Irving GF, Eriksdotter-Jönhagen M, Schultzberg M, Wahlund LO, Palmblad J. Reduced prostaglandin F2 alpha release from blood mononuclear leukocytes after oral supplementation of omega3 fatty acids: the OmegAD study. J Lipid Res. 2010 May;51(5):1179-85. Epub 2009 Nov 24.

Vedin I, Cederholm T, Freund Levi Y, Basun H, Garlind A, Faxén Irving G, Jönhagen ME, Vessby B, Wahlund LO, Palmblad J. Effects of docosahexaenoic acid-rich n-3 fatty acid supplementation on cytokine release from blood mononuclear leukocytes: the OmegAD study. Am J Clin Nutr. 2008 Jun;87(6):1616-22.

Freund-Levi Y, Basun H, Cederholm T, Faxén-Irving G, Garlind A, Grut M, Vedin I, Palmblad J, Wahlund LO, Eriksdotter-Jönhagen M. Omega-3 supplementation in mild to moderate Alzheimer's disease: effects on neuropsychiatric symptoms. Int J Geriatr Psychiatry. 2008 Feb;23(2):161-9.

ClinicalTrials.gov Identifier:	NCT00211159 History of Changes
Other Study ID Numbers:	OmegAD#1
Study First Received:	September 13, 2005
Last Updated:	February 7, 2007
Health Authority:	Sweden: Swedish National Council on Medical Ethics

Keywords provided by Karolinska University Hospital:

Alzheimer's disease
Omega-3 fatty acid
Dietary supplementation
Cognition
Safety

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 May 16, 2013

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