Memory Improvement With Docosahexaenoic Acid Study (MIDAS)

NCT ID: NCT00278135

Last Updated: 2014-05-19

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

485 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-12-31

Study Completion Date

2008-12-31

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.

Detailed Description

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Conditions

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Age-Related Cognitive Decline Age-Related Memory Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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1

Group Type ACTIVE_COMPARATOR

DHA (nutritional supplement) or placebo

Intervention Type DIETARY_SUPPLEMENT

oral 900mg/day

2

Group Type PLACEBO_COMPARATOR

DHA (nutritional supplement) or placebo

Intervention Type DIETARY_SUPPLEMENT

oral 900mg/day

Interventions

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DHA (nutritional supplement) or placebo

oral 900mg/day

Intervention Type DIETARY_SUPPLEMENT

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.
Minimum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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DSM Nutritional Products, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Pacific Research Network

San Diego, California, United States

Site Status

Pacific Research Network

Vista, California, United States

Site Status

Radiant Research Denver

Denver, Colorado, United States

Site Status

Bradenton Neurology

Bradenton, Florida, United States

Site Status

Brain Matters Research

Delray Beach, Florida, United States

Site Status

Meridien Research

St. Petersburg, Florida, United States

Site Status

Stedman Clinical Trials

Tampa, Florida, United States

Site Status

Radiant Research Chicago

Chicago, Illinois, United States

Site Status

Clinical Trial Center

Jenkintown, Pennsylvania, United States

Site Status

Senior Adults Specialty Research

Austin, Texas, United States

Site Status

Radiant Research San Antonio

San Antonio, Texas, United States

Site Status

Radiant Research Salt Lake City

Salt Lake City, Utah, United States

Site Status

Neurological Research Center, Inc.

Bennington, Vermont, United States

Site Status

Countries

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United States

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.

Reference Type DERIVED
PMID: 20434961 (View on PubMed)

Other Identifiers

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2005.1002

Identifier Type: -

Identifier Source: org_study_id

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