Memory Improvement With Docosahexaenoic Acid Study (MIDAS)
MIDAS
A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effects of DHA on Cognitive Functions in the Elderly
1 other identifier
interventional
485
1 country
14
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-3 fatty acid (LC-PUFA) that plays an important role in neural and visual development and cardiovascular health.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2005
Typical duration for not_applicable
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2005
CompletedFirst Submitted
Initial submission to the registry
January 13, 2006
CompletedFirst Posted
Study publicly available on registry
January 18, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2008
CompletedMay 19, 2014
May 1, 2014
2.8 years
January 13, 2006
May 16, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
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.
Study Arms (2)
1
ACTIVE COMPARATOR2
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (14)
Pivotal Research Center
Mesa, Arizona, 85210, United States
Pacific Research Network
San Diego, California, 92103, United States
Pacific Research Network
Vista, California, 92083, United States
Radiant Research Denver
Denver, Colorado, 80212, United States
Bradenton Neurology
Bradenton, Florida, 34205, United States
Brain Matters Research
Delray Beach, Florida, 33445, United States
Meridien Research
St. Petersburg, Florida, 33709, United States
Stedman Clinical Trials
Tampa, Florida, 33613, United States
Radiant Research Chicago
Chicago, Illinois, 60610, United States
Clinical Trial Center
Jenkintown, Pennsylvania, 19046, United States
Senior Adults Specialty Research
Austin, Texas, 78757, United States
Radiant Research San Antonio
San Antonio, Texas, 78229, United States
Radiant Research Salt Lake City
Salt Lake City, Utah, 84107, United States
Neurological Research Center, Inc.
Bennington, Vermont, 05201, United States
Related Publications (1)
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.
PMID: 20434961DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Karin Yurko-Mauro, PhD
DSM Nutritional Products, Inc.
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 13, 2006
First Posted
January 18, 2006
Study Start
December 1, 2005
Primary Completion
October 1, 2008
Study Completion
December 1, 2008
Last Updated
May 19, 2014
Record last verified: 2014-05