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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
History of Changes

January 13, 2006
May 21, 2009
December 2005
October 2008   (final data collection date for primary outcome measure)
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 ]
Determine the effects of DHA, a nutritional supplement (900mg/d) on improving cognitive functions (i.e. working memory, memory retention, attention, and executive function)in healthy elderly at 24 weeks.
Complete list of historical versions of study NCT00278135 on ClinicalTrials.gov Archive Site
  • 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.
Effects of DHA on visual acuity, levels of plasma phospholipids, and evaluating the safety and tolerability of the DHA dose administered. The study will include a Screening period, Baseline, & 24 week Treatment period.
Not Provided
Not Provided
 
Memory Improvement With Docosahexaenoic Acid Study (MIDAS)
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.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
  • Age-Related Cognitive Decline
  • Age-Related Memory Disorders
Dietary Supplement: DHA (nutritional supplement) or placebo
oral 900mg/day
  • Active Comparator: 1
    Intervention: Dietary Supplement: DHA (nutritional supplement) or placebo
  • Placebo Comparator: 2
    Intervention: Dietary Supplement: DHA (nutritional supplement) or placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
485
December 2008
October 2008   (final data collection date for primary outcome measure)

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.
Both
55 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00278135
2005.1002
No
Karin Yurko-Mauro, Martek Biosciences
Martek Biosciences Corporation
Not Provided
Study Director: Karin Yurko-Mauro, PhD Martek Biosciences Corporation
Martek Biosciences Corporation
May 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP