Memory Improvement With Docosahexaenoic Acid Study (MIDAS)
NCT ID: NCT00278135
Last Updated: 2014-05-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
485 participants
INTERVENTIONAL
2005-12-31
2008-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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1
DHA (nutritional supplement) or placebo
oral 900mg/day
2
DHA (nutritional supplement) or placebo
oral 900mg/day
Interventions
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DHA (nutritional supplement) or placebo
oral 900mg/day
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
55 Years
ALL
No
Sponsors
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DSM Nutritional Products, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Karin Yurko-Mauro, PhD
Role: STUDY_DIRECTOR
DSM Nutritional Products, Inc.
Locations
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Pivotal Research Center
Mesa, Arizona, United States
Pacific Research Network
San Diego, California, United States
Pacific Research Network
Vista, California, United States
Radiant Research Denver
Denver, Colorado, United States
Bradenton Neurology
Bradenton, Florida, United States
Brain Matters Research
Delray Beach, Florida, United States
Meridien Research
St. Petersburg, Florida, United States
Stedman Clinical Trials
Tampa, Florida, United States
Radiant Research Chicago
Chicago, Illinois, United States
Clinical Trial Center
Jenkintown, Pennsylvania, United States
Senior Adults Specialty Research
Austin, Texas, United States
Radiant Research San Antonio
San Antonio, Texas, United States
Radiant Research Salt Lake City
Salt Lake City, Utah, United States
Neurological Research Center, Inc.
Bennington, Vermont, United States
Countries
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References
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Yurko-Mauro K, McCarthy D, Rom D, Nelson EB, Ryan AS, Blackwell A, Salem N Jr, Stedman M; MIDAS Investigators. Beneficial effects of docosahexaenoic acid on cognition in age-related cognitive decline. Alzheimers Dement. 2010 Nov;6(6):456-64. doi: 10.1016/j.jalz.2010.01.013.
Other Identifiers
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2005.1002
Identifier Type: -
Identifier Source: org_study_id
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