Memory Improvement With Docosahexaenoic Acid Study (MIDAS)

DSM Nutritional Products

Status

Completed

Conditions

Age-Related Memory Disorders

Age-Related Cognitive Decline

Treatments

Dietary Supplement: DHA (nutritional supplement) or placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT00278135

2005.1002

Details and patient eligibility

About

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.

Enrollment

485 patients

Sex

All

Ages

55+ years old

Volunteers

No Healthy Volunteers

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.