Ignite Creation Date:
2025-12-24 @ 3:00 PM
Ignite Modification Date:
2025-12-25 @ 1:24 PM
Study NCT ID:
NCT00211159
Status:
COMPLETED
Last Update Posted:
2017-07-31
First Post:
2005-09-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
OmegAD (Omega-3 and Alzheimer's Disease)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000544', 'term': 'Alzheimer Disease'}], 'ancestors': [{'id': 'D003704', 'term': 'Dementia'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D024801', 'term': 'Tauopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'count': 204}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2000-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2005-04', 'lastUpdateSubmitDate': '2017-07-27', 'studyFirstSubmitDate': '2005-09-13', 'studyFirstSubmitQcDate': '2005-09-13', 'lastUpdatePostDateStruct': {'date': '2017-07-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2005-09-21', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cognition measured according to ADAS-cog, MMSE scales'}], 'secondaryOutcomes': [{'measure': 'Safety, tolerability, blood pressure'}, {'measure': 'Gene expression', 'timeFrame': '2007-2018', 'description': 'mRNA expression and DNA methylation changes in blood leukocytes in relation to changes of plasma and cerebrospinal concentrations of omega-3 fatty acids'}, {'measure': 'Dose-response studies in relation to APOE4 status, to body weight and to gender', 'timeFrame': '2007-2018', '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.'}]}, 'conditionsModule': {'keywords': ["Alzheimer's disease", 'Omega-3 fatty acid', 'Dietary supplementation', 'Cognition', 'Safety'], 'conditions': ["Alzheimer's Disease"]}, 'referencesModule': {'references': [{'pmid': '26402079', 'type': 'BACKGROUND', '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."}, {'pmid': '17030655', 'type': 'RESULT', '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.'}, {'pmid': '25616438', 'type': 'RESULT', '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.'}, {'pmid': '24934544', 'type': 'RESULT', '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."}, {'pmid': '24410954', 'type': 'RESULT', '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."}, {'pmid': '22545106', 'type': 'RESULT', '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.'}, {'pmid': '29154271', 'type': 'DERIVED', '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."}, {'pmid': '28855224', 'type': 'DERIVED', '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.'}, {'pmid': '19965584', 'type': 'DERIVED', '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.'}, {'pmid': '18541548', 'type': 'DERIVED', '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.'}, {'pmid': '17582225', 'type': 'DERIVED', '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."}]}, 'descriptionModule': {'briefSummary': "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"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': "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\n\nExclusion Criteria: Already treated with omega-3 fatty acids, NSAIDs, warfarin, being an alcohol abuser, suffering from serious concomitant disease or not having a caregiver"}, 'identificationModule': {'nctId': 'NCT00211159', 'briefTitle': "OmegAD (Omega-3 and Alzheimer's Disease)", 'organization': {'class': 'OTHER', 'fullName': 'Karolinska University Hospital'}, 'officialTitle': "Omega-3 Fatty Acid Treatment of 174 Patients With Mild to Moderate Alzheimer's Disease (OmegAD): a Randomized Double-blind Trial", 'orgStudyIdInfo': {'id': 'OmegAD#1'}}, 'armsInterventionsModule': {'interventions': [{'name': 'EPAX 1050TG', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'S-141 86', 'city': 'Stockholm', 'country': 'Sweden', 'facility': 'Karolinska University Hospital Huddinge', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}], 'overallOfficials': [{'name': 'Tommy Cederholm, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Uppsala University, Sweden'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Karolinska University Hospital', 'class': 'OTHER'}}}}