Ignite Creation Date:
2025-12-24 @ 10:23 PM
Ignite Modification Date:
2025-12-25 @ 7:55 PM
Study NCT ID:
NCT00278135
Status:
COMPLETED
Last Update Posted:
2014-05-19
First Post:
2006-01-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Memory Improvement With Docosahexaenoic Acid Study (MIDAS)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008569', 'term': 'Memory Disorders'}], 'ancestors': [{'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019587', 'term': 'Dietary Supplements'}], 'ancestors': [{'id': 'D005502', 'term': 'Food'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 485}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-05', 'completionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-05-16', 'studyFirstSubmitDate': '2006-01-13', 'studyFirstSubmitQcDate': '2006-01-13', 'lastUpdatePostDateStruct': {'date': '2014-05-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-01-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'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'}], 'secondaryOutcomes': [{'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.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Cognition', 'Memory', 'Nutrition', 'Omega-3', 'DHA'], 'conditions': ['Age-Related Cognitive Decline', 'Age-Related Memory Disorders']}, 'referencesModule': {'references': [{'pmid': '20434961', 'type': 'DERIVED', '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.'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '55 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Males or females, aged 55 or greater.\n* 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.\n* 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.\n* If taking non-prohibited medication, be on a stable drug regimen (in prior 3 months).\n\nExclusion Criteria:\n\n* Have a screening Mini-Mental State Examination (MMSE) \\< 26.\n* Consume greater than 200 mg/day DHA as assessed on a DHA Food Frequency Questionnaire in the prior 2 months to screening.\n* Use nutritional fish oil, flaxseed oil, omega-3 supplements, or huperzine in the prior 2 months to screening.\n* Use acetylcholinesterase inhibitors or memantine in the prior 2 months to screening.\n* Use major anti-psychotics or major anti-depressants.\n* Use lipase inhibitors such as Xenical® (orlistat).\n* 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.\n* History of major surgery within the past 6 months.\n* Current use or history of drug and/or alcohol abuse within 5 years.\n* Administration of any investigational product within the past 30 days.\n* Inability to swallow capsules.'}, 'identificationModule': {'nctId': 'NCT00278135', 'acronym': 'MIDAS', 'briefTitle': 'Memory Improvement With Docosahexaenoic Acid Study (MIDAS)', 'organization': {'class': 'INDUSTRY', 'fullName': 'DSM Nutritional Products, Inc.'}, 'officialTitle': 'A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effects of DHA on Cognitive Functions in the Elderly', 'orgStudyIdInfo': {'id': '2005.1002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'interventionNames': ['Dietary Supplement: DHA (nutritional supplement) or placebo']}, {'type': 'PLACEBO_COMPARATOR', 'label': '2', 'interventionNames': ['Dietary Supplement: DHA (nutritional supplement) or placebo']}], 'interventions': [{'name': 'DHA (nutritional supplement) or placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': 'oral 900mg/day', 'armGroupLabels': ['1', '2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85210', 'city': 'Mesa', 'state': 'Arizona', 'country': 'United States', 'facility': 'Pivotal Research Center', 'geoPoint': {'lat': 33.42227, 'lon': -111.82264}}, {'zip': '92103', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Pacific Research Network', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '92083', 'city': 'Vista', 'state': 'California', 'country': 'United States', 'facility': 'Pacific Research Network', 'geoPoint': {'lat': 33.20004, 'lon': -117.24254}}, {'zip': '80212', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'Radiant Research Denver', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '34205', 'city': 'Bradenton', 'state': 'Florida', 'country': 'United States', 'facility': 'Bradenton Neurology', 'geoPoint': {'lat': 27.49893, 'lon': -82.57482}}, {'zip': '33445', 'city': 'Delray Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Brain Matters Research', 'geoPoint': {'lat': 26.46146, 'lon': -80.07282}}, {'zip': '33709', 'city': 'St. Petersburg', 'state': 'Florida', 'country': 'United States', 'facility': 'Meridien Research', 'geoPoint': {'lat': 27.77086, 'lon': -82.67927}}, {'zip': '33613', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'Stedman Clinical Trials', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '60610', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Radiant Research Chicago', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '19046', 'city': 'Jenkintown', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Clinical Trial Center', 'geoPoint': {'lat': 40.09594, 'lon': -75.12517}}, {'zip': '78757', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'Senior Adults Specialty Research', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Radiant Research San Antonio', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '84107', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'Radiant Research Salt Lake City', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': '05201', 'city': 'Bennington', 'state': 'Vermont', 'country': 'United States', 'facility': 'Neurological Research Center, Inc.', 'geoPoint': {'lat': 42.87813, 'lon': -73.19677}}], 'overallOfficials': [{'name': 'Karin Yurko-Mauro, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'DSM Nutritional Products, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'DSM Nutritional Products, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}