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

Primary Purpose

Age-Related Cognitive Decline, Age-Related Memory Disorders

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
DHA (nutritional supplement) or placebo
Sponsored by
DSM Nutritional Products, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Age-Related Cognitive Decline focused on measuring Cognition, Memory, Nutrition, Omega-3, DHA

Eligibility Criteria

55 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Pivotal Research Center
  • Pacific Research Network
  • Pacific Research Network
  • Radiant Research Denver
  • Bradenton Neurology
  • Brain Matters Research
  • Meridien Research
  • Stedman Clinical Trials
  • Radiant Research Chicago
  • Clinical Trial Center
  • Senior Adults Specialty Research
  • Radiant Research San Antonio
  • Radiant Research Salt Lake City
  • Neurological Research Center, Inc.

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

1

2

Arm Description

Outcomes

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

Secondary Outcome Measures

Effects of DHA on visual acuity, levels of plasma phospholipids, and evaluating the safety and tolerability of the DHA dose administered
The study will include a screening period, baseline, and 24 week treatment period.

Full Information

First Posted
January 13, 2006
Last Updated
May 16, 2014
Sponsor
DSM Nutritional Products, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00278135
Brief Title
Memory Improvement With Docosahexaenoic Acid Study (MIDAS)
Acronym
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

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
December 2005 (undefined)
Primary Completion Date
October 2008 (Actual)
Study Completion Date
December 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
DSM Nutritional Products, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Age-Related Cognitive Decline, Age-Related Memory Disorders
Keywords
Cognition, Memory, Nutrition, Omega-3, DHA

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
485 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Title
2
Arm Type
Placebo Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
DHA (nutritional supplement) or placebo
Intervention Description
oral 900mg/day
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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
Title
The study will include a screening period, baseline, and 24 week treatment period.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karin Yurko-Mauro, PhD
Organizational Affiliation
DSM Nutritional Products, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Pivotal Research Center
City
Mesa
State/Province
Arizona
ZIP/Postal Code
85210
Country
United States
Facility Name
Pacific Research Network
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
Pacific Research Network
City
Vista
State/Province
California
ZIP/Postal Code
92083
Country
United States
Facility Name
Radiant Research Denver
City
Denver
State/Province
Colorado
ZIP/Postal Code
80212
Country
United States
Facility Name
Bradenton Neurology
City
Bradenton
State/Province
Florida
ZIP/Postal Code
34205
Country
United States
Facility Name
Brain Matters Research
City
Delray Beach
State/Province
Florida
ZIP/Postal Code
33445
Country
United States
Facility Name
Meridien Research
City
St. Petersburg
State/Province
Florida
ZIP/Postal Code
33709
Country
United States
Facility Name
Stedman Clinical Trials
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
Country
United States
Facility Name
Radiant Research Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60610
Country
United States
Facility Name
Clinical Trial Center
City
Jenkintown
State/Province
Pennsylvania
ZIP/Postal Code
19046
Country
United States
Facility Name
Senior Adults Specialty Research
City
Austin
State/Province
Texas
ZIP/Postal Code
78757
Country
United States
Facility Name
Radiant Research San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Radiant Research Salt Lake City
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Facility Name
Neurological Research Center, Inc.
City
Bennington
State/Province
Vermont
ZIP/Postal Code
05201
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
20434961
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.
Results Reference
derived

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Memory Improvement With Docosahexaenoic Acid Study (MIDAS)

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