Memory Improvement With Docosahexaenoic Acid Study (MIDAS) (MIDAS)

May 16, 2014 updated by: DSM Nutritional Products, Inc.

A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effects of DHA on Cognitive Functions in the Elderly

The purpose of this study is to investigate the effect of docosahexaenoic acid (DHA, 22:6n-3) in improving cognitive functions in subjects with age-related cognitive decline. DHA is a long chain omega-3 fatty acid (LC-PUFA) that plays an important role in neural and visual development and cardiovascular health.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

485

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Mesa, Arizona, United States, 85210
        • Pivotal Research Center
    • California
      • San Diego, California, United States, 92103
        • Pacific Research Network
      • Vista, California, United States, 92083
        • Pacific Research Network
    • Colorado
      • Denver, Colorado, United States, 80212
        • Radiant Research Denver
    • Florida
      • Bradenton, Florida, United States, 34205
        • Bradenton Neurology
      • Delray Beach, Florida, United States, 33445
        • Brain Matters Research
      • St. Petersburg, Florida, United States, 33709
        • Meridien Research
      • Tampa, Florida, United States, 33613
        • Stedman Clinical Trials
    • Illinois
      • Chicago, Illinois, United States, 60610
        • Radiant Research Chicago
    • Pennsylvania
      • Jenkintown, Pennsylvania, United States, 19046
        • Clinical Trial Center
    • Texas
      • Austin, Texas, United States, 78757
        • Senior Adults Specialty Research
      • San Antonio, Texas, United States, 78229
        • Radiant Research San Antonio
    • Utah
      • Salt Lake City, Utah, United States, 84107
        • Radiant Research Salt Lake City
    • Vermont
      • Bennington, Vermont, United States, 05201
        • Neurological Research Center, Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Males or females, aged 55 or greater.
  • Have a subjective memory complaint and have a Logical Memory subtest (of the Wechsler Memory Scale - III [WMS-III]) raw score one standard deviation or greater below the mean of a younger population.
  • Have the ability to understand the requirements of the study; be willing to provide written informed consent; and agree to abide by the study restrictions and return for the required assessments.
  • If taking non-prohibited medication, be on a stable drug regimen (in prior 3 months).

Exclusion Criteria:

  • Have a screening Mini-Mental State Examination (MMSE) < 26.
  • Consume greater than 200 mg/day DHA as assessed on a DHA Food Frequency Questionnaire in the prior 2 months to screening.
  • Use nutritional fish oil, flaxseed oil, omega-3 supplements, or huperzine in the prior 2 months to screening.
  • Use acetylcholinesterase inhibitors or memantine in the prior 2 months to screening.
  • Use major anti-psychotics or major anti-depressants.
  • Use lipase inhibitors such as Xenical® (orlistat).
  • History of major medical conditions including ischemic stroke, head trauma with loss of consciousness, epilepsy, psychosis, vascular dementia, depression (Geriatric Depression [15-item] > 5), myocardial infarction (within 1 year), uncontrolled diabetes, or blindness.
  • History of major surgery within the past 6 months.
  • Current use or history of drug and/or alcohol abuse within 5 years.
  • Administration of any investigational product within the past 30 days.
  • Inability to swallow capsules.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 2
Dietary supplement: DHA (nutritional supplement) or placebo
oral 900mg/day
Active Comparator: 1
Dietary supplement: DHA (nutritional supplement) or placebo
oral 900mg/day

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Determine the effects of DHA, a nutritional supplement (900 mg/d) on improving cognitive functions (i.e. working memory, memory retention, attention, and executive function) in healthy elderly subjects at 24 weeks
Time Frame: 24 weeks
24 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Effects of DHA on visual acuity, levels of plasma phospholipids, and evaluating the safety and tolerability of the DHA dose administered
Time Frame: 24 weeks
24 weeks
The study will include a screening period, baseline, and 24 week treatment period.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

DSM Nutritional Products, Inc.

Investigators

  • Study Director: Karin Yurko-Mauro, PhD, DSM Nutritional Products, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2005

Primary Completion (Actual)

October 1, 2008

Study Completion (Actual)

December 1, 2008

Study Registration Dates

First Submitted

January 13, 2006

First Submitted That Met QC Criteria

January 13, 2006

First Posted (Estimate)

January 18, 2006

Study Record Updates

Last Update Posted (Estimate)

May 19, 2014

Last Update Submitted That Met QC Criteria

May 16, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2005.1002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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