Memory Improvement With Docosahexaenoic Acid Study (MIDAS)
- Conditions
- Age-Related Cognitive DeclineAge-Related Memory Disorders
- Interventions
- Dietary Supplement: DHA (nutritional supplement) or placebo
- Registration Number
- NCT00278135
- Lead Sponsor
- DSM Nutritional Products, Inc.
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 485
- 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).
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 DHA (nutritional supplement) or placebo - 2 DHA (nutritional supplement) or placebo -
- Primary Outcome Measures
Name Time Method 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 24 weeks
- Secondary Outcome Measures
Name Time Method Effects of DHA on visual acuity, levels of plasma phospholipids, and evaluating the safety and tolerability of the DHA dose administered 24 weeks The study will include a screening period, baseline, and 24 week treatment period.
Trial Locations
- Locations (13)
Pacific Research Network
🇺🇸Vista, California, United States
Neurological Research Center, Inc.
🇺🇸Bennington, Vermont, United States
Clinical Trial Center
🇺🇸Jenkintown, Pennsylvania, United States
Radiant Research Denver
🇺🇸Denver, Colorado, United States
Stedman Clinical Trials
🇺🇸Tampa, Florida, United States
Radiant Research Salt Lake City
🇺🇸Salt Lake City, Utah, United States
Radiant Research Chicago
🇺🇸Chicago, Illinois, United States
Pivotal Research Center
🇺🇸Mesa, Arizona, United States
Bradenton Neurology
🇺🇸Bradenton, Florida, United States
Brain Matters Research
🇺🇸Delray Beach, Florida, United States
Meridien Research
🇺🇸St. Petersburg, Florida, United States
Radiant Research San Antonio
🇺🇸San Antonio, Texas, United States
Senior Adults Specialty Research
🇺🇸Austin, Texas, United States