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OmegAD (Omega-3 and Alzheimer's Disease)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00211159
Recruitment Status : Completed
First Posted : September 21, 2005
Last Update Posted : July 31, 2017
Sponsor:
Information provided by:
Karolinska University Hospital

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

Condition or disease Intervention/treatment
Alzheimer's Disease Drug: EPAX 1050TG

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 204 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
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
Study Start Date : December 2000

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  1. Cognition measured according to ADAS-cog, MMSE scales

Secondary Outcome Measures :
  1. Safety, tolerability, blood pressure
  2. Gene expression [ Time Frame: 2007-2018 ]
    mRNA expression and DNA methylation changes in blood leukocytes in relation to changes of plasma and cerebrospinal concentrations of omega-3 fatty acids

  3. Dose-response studies in relation to APOE4 status, to body weight and to gender [ Time Frame: 2007-2018 ]
    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.



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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 Uppsala University, Sweden

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00211159     History of Changes
Other Study ID Numbers: OmegAD#1
First Posted: September 21, 2005    Key Record Dates
Last Update Posted: July 31, 2017
Last Verified: April 2005

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
Neurocognitive Disorders
Mental Disorders