OmegAD (Omega-3 and Alzheimer's Disease)
Primary Purpose
Alzheimer's Disease
Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
EPAX 1050TG
Sponsored by
About this trial
This is an interventional treatment trial for Alzheimer's Disease focused on measuring Alzheimer's disease, Omega-3 fatty acid, Dietary supplementation, Cognition, Safety
Eligibility 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
Sites / Locations
- Karolinska University Hospital Huddinge
Outcomes
Primary Outcome Measures
Cognition measured according to ADAS-cog, MMSE scales
Secondary Outcome Measures
Safety, tolerability, blood pressure
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
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.
Full Information
NCT ID
NCT00211159
First Posted
September 13, 2005
Last Updated
July 27, 2017
Sponsor
Karolinska University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00211159
Brief Title
OmegAD (Omega-3 and Alzheimer's Disease)
Official Title
Omega-3 Fatty Acid Treatment of 174 Patients With Mild to Moderate Alzheimer's Disease (OmegAD): a Randomized Double-blind Trial
Study Type
Interventional
2. Study Status
Record Verification Date
April 2005
Overall Recruitment Status
Completed
Study Start Date
December 2000 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Karolinska University Hospital
4. Oversight
5. Study Description
Brief 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease
Keywords
Alzheimer's disease, Omega-3 fatty acid, Dietary supplementation, Cognition, Safety
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Double
Allocation
Randomized
Enrollment
204 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
EPAX 1050TG
Primary Outcome Measure Information:
Title
Cognition measured according to ADAS-cog, MMSE scales
Secondary Outcome Measure Information:
Title
Safety, tolerability, blood pressure
Title
Gene expression
Description
mRNA expression and DNA methylation changes in blood leukocytes in relation to changes of plasma and cerebrospinal concentrations of omega-3 fatty acids
Time Frame
2007-2018
Title
Dose-response studies in relation to APOE4 status, to body weight and to gender
Description
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.
Time Frame
2007-2018
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tommy Cederholm, MD, PhD
Organizational Affiliation
Uppsala University, Sweden
Official's Role
Principal Investigator
Facility Information:
Facility Name
Karolinska University Hospital Huddinge
City
Stockholm
ZIP/Postal Code
S-141 86
Country
Sweden
12. IPD Sharing Statement
Citations:
PubMed Identifier
26402079
Citation
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.
Results Reference
background
PubMed Identifier
17030655
Citation
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. doi: 10.1001/archneur.63.10.1402.
Results Reference
result
PubMed Identifier
25616438
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 Mar;56(3):674-681. doi: 10.1194/jlr.P055418. Epub 2015 Jan 23.
Results Reference
result
PubMed Identifier
24934544
Citation
Freund-Levi Y, Vedin I, Hjorth E, Basun H, Faxen 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 Alzheimer's disease: the OmegAD study. J Alzheimers Dis. 2014;42(3):823-31. doi: 10.3233/JAD-132042.
Results Reference
result
PubMed Identifier
24410954
Citation
Freund Levi Y, Vedin I, Cederholm T, Basun H, Faxen 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 docosahexaenoic acid-rich omega-3 fatty acid preparation in patients with Alzheimer's disease: the OmegAD study. J Intern Med. 2014 Apr;275(4):428-36. doi: 10.1111/joim.12166. Epub 2014 Jan 11.
Results Reference
result
PubMed Identifier
22545106
Citation
Vedin I, Cederholm T, Freund-Levi Y, Basun H, Garlind A, Irving GF, Eriksdotter-Jonhagen 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. doi: 10.1371/journal.pone.0035425. Epub 2012 Apr 24.
Results Reference
result
PubMed Identifier
29154271
Citation
Faxen-Irving G, Falahati F, Basun H, Eriksdotter M, Vedin I, Wahlund LO, Schultzberg M, Hjorth E, Palmblad J, Cederholm T, Freund-Levi Y. Does Fatty Acid Composition in Subcutaneous Adipose Tissue Differ between Patients with Alzheimer's Disease and Cohabiting Proxies? J Alzheimers Dis. 2018;61(2):515-519. doi: 10.3233/JAD-170359.
Results Reference
derived
PubMed Identifier
28855224
Citation
Karimi M, Vedin I, Freund Levi Y, Basun H, Faxen Irving G, Eriksdotter M, Wahlund LO, Schultzberg M, Hjorth E, Cederholm T, Palmblad J. DHA-rich n-3 fatty acid supplementation decreases DNA methylation in blood leukocytes: the OmegAD study. Am J Clin Nutr. 2017 Oct;106(4):1157-1165. doi: 10.3945/ajcn.117.155648. Epub 2017 Aug 30.
Results Reference
derived
PubMed Identifier
19965584
Citation
Vedin I, Cederholm T, Freund-Levi Y, Basun H, Hjorth E, Irving GF, Eriksdotter-Jonhagen 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. doi: 10.1194/jlr.M002667. Epub 2009 Nov 24.
Results Reference
derived
PubMed Identifier
18541548
Citation
Vedin I, Cederholm T, Freund Levi Y, Basun H, Garlind A, Faxen Irving G, Jonhagen 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. doi: 10.1093/ajcn/87.6.1616.
Results Reference
derived
PubMed Identifier
17582225
Citation
Freund-Levi Y, Basun H, Cederholm T, Faxen-Irving G, Garlind A, Grut M, Vedin I, Palmblad J, Wahlund LO, Eriksdotter-Jonhagen 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. doi: 10.1002/gps.1857.
Results Reference
derived
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OmegAD (Omega-3 and Alzheimer's Disease)
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