Status:
COMPLETED
Memory Improvement With Docosahexaenoic Acid Study (MIDAS)
Lead Sponsor:
DSM Nutritional Products, Inc.
Conditions:
Age-Related Cognitive Decline
Age-Related Memory Disorders
Eligibility:
All Genders
55+ years
Phase:
NA
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
485 Patients enrolled
Trial Details
Trial ID
NCT00278135
Start Date
December 1 2005
End Date
December 1 2008
Last Update
May 19 2014
Active Locations (14)
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1
Pivotal Research Center
Mesa, Arizona, United States, 85210
2
Pacific Research Network
San Diego, California, United States, 92103
3
Pacific Research Network
Vista, California, United States, 92083
4
Radiant Research Denver
Denver, Colorado, United States, 80212