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.

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.