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Completed

NCT Number: NCT00278135

Memory Improvement With Docosahexaenoic Acid Study (MIDAS)

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.

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Key information

Age range

55 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pivotal Research Center, Mesa, Arizona, United States

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Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

DHA (nutritional supplement) or placebo

Dietary Supplement

oral 900mg/day

Primary outcomes

  1. 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 outcomes

  1. 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

  2. The study will include a screening period, baseline, and 24 week treatment period.

Sponsors and collaborators

Lead sponsor

dsm-firmenich Switzerland AG

Industry

Registry information

Official study title

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

Acronym: MIDAS

Important dates

Study start
2005
Primary completion
2008
Study completion
2008
First posted
Jan 18, 2006
Registry last updated
May 19, 2014

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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