Memory Improvement With Docosahexaenoic Acid Study (MIDAS)

Age-Related Cognitive Decline Clinical Trial

— MIDAS  

Official title:

A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effects of DHA on Cognitive Functions in the Elderly

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00278135
• Other study ID #: 2005.1002
• Status: Completed
• Phase: N/A
• First received: January 13, 2006
• Last updated: May 16, 2014
• Start date: December 2005
• Est. completion date: December 2008

Study information

• Verified date: May 2014
• Source: DSM Nutritional Products, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 485
• Est. completion date: December 2008
• Est. primary completion date: October 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 55 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Age-Related Cognitive Decline
• Age-Related Memory Disorders
• Memory Disorders

Intervention

Dietary Supplement:
• DHA (nutritional supplement) or placebo
oral 900mg/day

Locations

Country	Name	City	State
United States	Senior Adults Specialty Research	Austin	Texas
United States	Neurological Research Center, Inc.	Bennington	Vermont
United States	Bradenton Neurology	Bradenton	Florida
United States	Radiant Research Chicago	Chicago	Illinois
United States	Brain Matters Research	Delray Beach	Florida
United States	Radiant Research Denver	Denver	Colorado
United States	Clinical Trial Center	Jenkintown	Pennsylvania
United States	Pivotal Research Center	Mesa	Arizona
United States	Radiant Research Salt Lake City	Salt Lake City	Utah
United States	Radiant Research San Antonio	San Antonio	Texas
United States	Pacific Research Network	San Diego	California
United States	Meridien Research	St. Petersburg	Florida
United States	Stedman Clinical Trials	Tampa	Florida
United States	Pacific Research Network	Vista	California

Sponsors (1)

Lead Sponsor	Collaborator
DSM Nutritional Products, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Effects of DHA on visual acuity, levels of plasma phospholipids, and evaluating the safety and tolerability of the DHA dose administered		24 weeks
Secondary	The study will include a screening period, baseline, and 24 week treatment period.