Memory Improvement With Docosahexaenoic Acid Study (MIDAS)

This study has been completed.
Sponsor:
Information provided by:
Martek Biosciences Corporation
ClinicalTrials.gov Identifier:
NCT00278135
First received: January 13, 2006
Last updated: May 21, 2009
Last verified: May 2009
  Purpose

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.


Condition Intervention
Age-Related Cognitive Decline
Age-Related Memory Disorders
Dietary Supplement: DHA (nutritional supplement) or placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effects of DHA on Cognitive Functions in the Elderly

Resource links provided by NLM:


Further study details as provided by Martek Biosciences Corporation:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]
  • The study will include a screening period, baseline, and 24 week treatment period.

Enrollment: 485
Study Start Date: December 2005
Study Completion Date: December 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1 Dietary Supplement: DHA (nutritional supplement) or placebo
oral 900mg/day
Placebo Comparator: 2 Dietary Supplement: DHA (nutritional supplement) or placebo
oral 900mg/day

  Eligibility

Ages Eligible for Study:   55 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00278135

Locations
United States, Arizona
Pivotal Research Center
Mesa, Arizona, United States, 85210
United States, California
Pacific Research Network
San Diego, California, United States, 92103
Pacific Research Network
Vista, California, United States, 92083
United States, Colorado
Radiant Research Denver
Denver, Colorado, United States, 80212
United States, Florida
Bradenton Neurology
Bradenton, Florida, United States, 34205
Brain Matters Research
Delray Beach, Florida, United States, 33445
Meridien Research
St. Petersburg, Florida, United States, 33709
Stedman Clinical Trials
Tampa, Florida, United States, 33613
United States, Illinois
Radiant Research Chicago
Chicago, Illinois, United States, 60610
United States, Pennsylvania
Clinical Trial Center
Jenkintown, Pennsylvania, United States, 19046
United States, Texas
Senior Adults Specialty Research
Austin, Texas, United States, 78757
Radiant Research San Antonio
San Antonio, Texas, United States, 78229
United States, Utah
Radiant Research Salt Lake City
Salt Lake City, Utah, United States, 84107
United States, Vermont
Neurological Research Center, Inc.
Bennington, Vermont, United States, 05201
Sponsors and Collaborators
Martek Biosciences Corporation
Investigators
Study Director: Karin Yurko-Mauro, PhD Martek Biosciences Corporation
  More Information

No publications provided

Responsible Party: Karin Yurko-Mauro, Martek Biosciences
ClinicalTrials.gov Identifier: NCT00278135     History of Changes
Other Study ID Numbers: 2005.1002
Study First Received: January 13, 2006
Last Updated: May 21, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Martek Biosciences Corporation:
Cognition
Memory
Nutrition
Omega-3
DHA

Additional relevant MeSH terms:
Memory Disorders
Cognition Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on April 16, 2014