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OpenTrials
Completed

NCT Number: NCT00211159

OmegAD (Omega-3 and Alzheimer's Disease)

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

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Key information

Conditions

Alzheimer's Disease Alzheimer Disease Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Karolinska University Hospital Huddinge

Stockholm, S-141 86, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

EPAX 1050TG

Drug

Primary outcomes

  1. Cognition measured according to ADAS-cog, MMSE scales

Secondary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Karolinska University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2000
First posted
Sep 21, 2005
Registry last updated
Jul 31, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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