Clinical trial NCT00278135: Memory Improvement With Docosahexaenoic Acid Study (MIDAS)
Official title: A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effects of DHA on Cognitive Functions in the Elderly
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Age-Related Cognitive Decline
Age-Related Memory Disorders
Keywords: Cognition
Memory
Nutrition
Omega-3
DHA
Lead sponsor: DSM Nutritional Products, Inc.
Sponsor class: INDUSTRY
First posted: 2006-01-18
Enrollment: 485
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: 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
timeFrame: 24 weeks
Secondary outcomes:
measure: Effects of DHA on visual acuity, levels of plasma phospholipids, and evaluating the safety and tolerability of the DHA dose administered
timeFrame: 24 weeks
measure: The study will include a screening period, baseline, and 24 week treatment period.
Other outcomes:
Locations:
city: Mesa
country: United States
facility: Pivotal Research Center
state: Arizona
city: San Diego
country: United States
facility: Pacific Research Network
state: California
city: Vista
country: United States
facility: Pacific Research Network
state: California
city: Denver
country: United States
facility: Radiant Research Denver
state: Colorado
city: Bradenton
country: United States
facility: Bradenton Neurology
state: Florida
city: Delray Beach
country: United States
facility: Brain Matters Research
state: Florida
city: St. Petersburg
country: United States
facility: Meridien Research
state: Florida
city: Tampa
country: United States
facility: Stedman Clinical Trials
state: Florida
city: Chicago
country: United States
facility: Radiant Research Chicago
state: Illinois
city: Jenkintown
country: United States
facility: Clinical Trial Center
state: Pennsylvania
city: Austin
country: United States
facility: Senior Adults Specialty Research
state: Texas
city: San Antonio
country: United States
facility: Radiant Research San Antonio
state: Texas
city: Salt Lake City
country: United States
facility: Radiant Research Salt Lake City
state: Utah
city: Bennington
country: United States
facility: Neurological Research Center, Inc.
state: Vermont
Study officials:
affiliation: DSM Nutritional Products, Inc.
name: Karin Yurko-Mauro, PhD
role: STUDY_DIRECTOR
References:
citation: 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.