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Memory Improvement With Docosahexaenoic Acid Study (MIDAS) (MIDAS)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00278135
First Posted: January 18, 2006
Last Update Posted: May 19, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
DSM Nutritional Products, Inc.
  Purpose
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.

Condition Intervention
Age-Related Cognitive Decline Age-Related Memory Disorders Dietary Supplement: DHA (nutritional supplement) or placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effects of DHA on Cognitive Functions in the Elderly

Resource links provided by NLM:


Further study details as provided by DSM Nutritional Products, Inc.:

Primary Outcome Measures:
  • 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 [ Time Frame: 24 weeks ]

Secondary Outcome Measures:
  • Effects of DHA on visual acuity, levels of plasma phospholipids, and evaluating the safety and tolerability of the DHA dose administered [ Time Frame: 24 weeks ]
  • The study will include a screening period, baseline, and 24 week treatment period.

Enrollment: 485
Study Start Date: December 2005
Study Completion Date: December 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1 Dietary Supplement: DHA (nutritional supplement) or placebo
oral 900mg/day
Placebo Comparator: 2 Dietary Supplement: DHA (nutritional supplement) or placebo
oral 900mg/day

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   55 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00278135


Locations
United States, Arizona
Pivotal Research Center
Mesa, Arizona, United States, 85210
United States, California
Pacific Research Network
San Diego, California, United States, 92103
Pacific Research Network
Vista, California, United States, 92083
United States, Colorado
Radiant Research Denver
Denver, Colorado, United States, 80212
United States, Florida
Bradenton Neurology
Bradenton, Florida, United States, 34205
Brain Matters Research
Delray Beach, Florida, United States, 33445
Meridien Research
St. Petersburg, Florida, United States, 33709
Stedman Clinical Trials
Tampa, Florida, United States, 33613
United States, Illinois
Radiant Research Chicago
Chicago, Illinois, United States, 60610
United States, Pennsylvania
Clinical Trial Center
Jenkintown, Pennsylvania, United States, 19046
United States, Texas
Senior Adults Specialty Research
Austin, Texas, United States, 78757
Radiant Research San Antonio
San Antonio, Texas, United States, 78229
United States, Utah
Radiant Research Salt Lake City
Salt Lake City, Utah, United States, 84107
United States, Vermont
Neurological Research Center, Inc.
Bennington, Vermont, United States, 05201
Sponsors and Collaborators
DSM Nutritional Products, Inc.
Investigators
Study Director: Karin Yurko-Mauro, PhD DSM Nutritional Products, Inc.
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: DSM Nutritional Products, Inc.
ClinicalTrials.gov Identifier: NCT00278135     History of Changes
Other Study ID Numbers: 2005.1002
First Submitted: January 13, 2006
First Posted: January 18, 2006
Last Update Posted: May 19, 2014
Last Verified: May 2014

Keywords provided by DSM Nutritional Products, Inc.:
Cognition
Memory
Nutrition
Omega-3
DHA

Additional relevant MeSH terms:
Cognitive Dysfunction
Memory Disorders
Cognition Disorders
Neurocognitive Disorders
Mental Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms