OmegAD (Omega-3 and Alzheimer's Disease)

Alzheimer's Disease Clinical Trial

Official title:

Omega-3 Fatty Acid Treatment of 174 Patients With Mild to Moderate Alzheimer's Disease (OmegAD): a Randomized Double-blind Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00211159
• Other study ID #: OmegAD#1
• Status: Completed
• Phase: N/A
• First received: September 13, 2005
• Last updated: July 27, 2017
• Start date: December 2000

Study information

• Verified date: April 2005
• Source: Karolinska University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 204
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Intervention

Drug:
• EPAX 1050TG

Locations

Country	Name	City	State
Sweden	Karolinska University Hospital Huddinge	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska University Hospital

Country where clinical trial is conducted

Sweden, 

References & Publications (6)

Eriksdotter M, Vedin I, Falahati F, Freund-Levi Y, Hjorth E, Faxen-Irving G, Wahlund LO, Schultzberg M, Basun H, Cederholm T, Palmblad J. Plasma Fatty Acid Profiles in Relation to Cognition and Gender in Alzheimer's Disease Patients During Oral Omega-3 Fatty Acid Supplementation: The OmegAD Study. J Alzheimers Dis. 2015;48(3):805-12. doi: 10.3233/JAD-150102. — View Citation

Freund Levi Y, Vedin I, Cederholm T, Basun H, Faxén Irving G, Eriksdotter M, Hjorth E, Schultzberg M, Vessby B, Wahlund LO, Salem N Jr, Palmblad J. Transfer of omega-3 fatty acids across the blood-brain barrier after dietary supplementation with a docosah — View Citation

Freund-Levi Y, Eriksdotter-Jönhagen M, Cederholm T, Basun H, Faxén-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-blin — View Citation

Freund-Levi Y, Vedin I, Hjorth E, Basun H, Faxén Irving G, Schultzberg M, Eriksdotter M, Palmblad J, Vessby B, Wahlund LO, Cederholm T, Basu S. Effects of supplementation with omega-3 fatty acids on oxidative stress and inflammation in patients with Alzhe — View Citation

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 On — View Citation

Wang X, Hjorth E, Vedin I, Eriksdotter M, Freund-Levi Y, Wahlund LO, Cederholm T, Palmblad J, Schultzberg M. Effects of n-3 FA supplementation on the release of proresolving lipid mediators by blood mononuclear cells: the OmegAD study. J Lipid Res. 2015 M — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cognition measured according to ADAS-cog, MMSE scales
Secondary	Safety, tolerability, blood pressure
Secondary	Gene expression	mRNA expression and DNA methylation changes in blood leukocytes in relation to changes of plasma and cerebrospinal concentrations of omega-3 fatty acids	2007-2018
Secondary	Dose-response studies in relation to APOE4 status, to body weight and to gender	Analysis of changes of plasma and cerebrospinal fluid concentrations of omega-3 fatty acids in relation to APOE4 status, body weight and gender, as well as to changes in ADAS-cog and MMSE as measures of cognition.	2007-2018