Memory Improvement With Docosahexaenoic Acid Study (MIDAS)

Study Overview
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Brief Summary
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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.

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

Conditions
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Age-Related Cognitive Decline, Age-Related Memory Disorders

Intervention / Treatment
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* Dietary Supplement: DHA (nutritional supplement) or placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br> | Dietary Supplement: DHA (nutritional supplement) or placebo<br>* oral 900mg/day<br>|
| Placebo Comparator: 2<br> | Dietary Supplement: DHA (nutritional supplement) or placebo<br>* oral 900mg/day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cognition, Memory, Nutrition, Omega-3, DHA