OmegAD (Omega-3 and Alzheimer's Disease)

This study has been completed.
Sponsor:
Information provided by:
Karolinska University Hospital
ClinicalTrials.gov Identifier:
NCT00211159
First received: September 13, 2005
Last updated: February 7, 2007
Last verified: April 2005
  Purpose

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 Intervention
Alzheimer's Disease
Drug: EPAX 1050TG

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
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

Resource links provided by NLM:


Further study details as provided by Karolinska University Hospital:

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

Secondary Outcome Measures:
  • Safety, tolerability, blood pressure

Estimated Enrollment: 204
Study Start Date: December 2000
  Eligibility

Genders Eligible for Study:   Both
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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 Karolinska University Hospital
  More Information

Publications:
Additional 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
Study First Received: September 13, 2005
Last Updated: February 7, 2007
Health Authority: Sweden: Swedish National Council on Medical Ethics

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
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on September 18, 2014