Ignite Creation Date:
2025-12-24 @ 4:55 PM
Ignite Modification Date:
2025-12-27 @ 11:23 AM
Study NCT ID:
NCT00355550
Status:
COMPLETED
Last Update Posted:
2020-09-18
First Post:
2006-07-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Tricaprilin In Age-Associated Memory Impairment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D060825', 'term': 'Cognitive Dysfunction'}, {'id': 'D003072', 'term': 'Cognition Disorders'}], 'ancestors': [{'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C003637', 'term': 'tricaprylin'}, {'id': 'C538853', 'term': 'AC-1202'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 156}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2007-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-09-16', 'studyFirstSubmitDate': '2006-07-20', 'studyFirstSubmitQcDate': '2006-07-20', 'lastUpdatePostDateStruct': {'date': '2020-09-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2006-07-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in Psychologix and Cogscreen Test Batteries, RAVLT (Rey Auditory Verbal Learning Test)', 'timeFrame': '90 days'}, {'measure': 'Number of subjects with treatment related adverse events', 'timeFrame': '90 days', 'description': 'AE incidence rate per treatment group'}], 'secondaryOutcomes': [{'measure': 'Self-reported memory improvement', 'timeFrame': '90 days'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Mild Cognitive Impairment', 'Cognition disorders', 'nutritional supplement', 'dietary supplement'], 'conditions': ['Age-Associated Memory Impairment']}, 'referencesModule': {'references': [{'pmid': '15123336', 'type': 'BACKGROUND', 'citation': 'Reger MA, Henderson ST, Hale C, Cholerton B, Baker LD, Watson GS, Hyde K, Chapman D, Craft S. Effects of beta-hydroxybutyrate on cognition in memory-impaired adults. Neurobiol Aging. 2004 Mar;25(3):311-4. doi: 10.1016/S0197-4580(03)00087-3.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether tricaprilin, a compound that increases energy availability in the brain, improves memory in older adults with "normal" loss of memory abilities since early adult life.', 'detailedDescription': 'One physiological hallmark of aging in mammals is a decreased uptake and metabolism of glucose within the brain. The impaired glucose metabolism in the brain may contribute or exacerbate the cognitive deficits observed during normal aging. Facilitation of memory in elderly individuals occurs when glucose levels are elevated by the administration of carbohydrate. However, such a treatment poses challenges since elevated blood glucose levels are difficult to maintain and must be within a relatively narrow window, as excessive hyperglycemia is associated with cognitive impairments. The purpose of this study is to explore whether increasing levels of other substrates for the brain improves cognitive functioning in normal aged individuals with memory disorders.\n\nStudy participants will be 120 men and women aged 50-85 who have been diagnosed as having Age-Associated Memory Impairment (AAMI). During the double-blind period of the protocol, 60 participants will receive tricaprilin and 60 participants will receive a matching placebo. Tricaprilin or the matching placebo will be administered once a day for ninety days by mixing powder in 8 ounces of a liquid. Each participant will be seen six (6) times: at Screening; Baseline; treatment days Days 30, 60, 90; and 14 days after the conclusion of treatment (Day 104).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Complaints that memory has declined since young adult life\n* Scores on standardized tests that are at least one standard deviation below the mean score of young adults\n\nExclusion Criteria:\n\n* Dementia, including Alzheimer's disease and Mild Cognitive Impairment (MCI)\n* Drugs that impair cognition\n* Psychiatric conditions that may impair cognition (e.g.,depression etc.)"}, 'identificationModule': {'nctId': 'NCT00355550', 'briefTitle': 'Tricaprilin In Age-Associated Memory Impairment', 'organization': {'class': 'INDUSTRY', 'fullName': 'Cerecin'}, 'officialTitle': 'A Double-Blind, Placebo-Controlled Study of Tricaprilin (AC-1202) Administered For Ninety Days In Subjects With Age-Associated Memory Impairment', 'orgStudyIdInfo': {'id': 'KET-06-003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'AC-1202', 'description': 'Tricaprilin formulation, once daily. Administered orally', 'interventionNames': ['Drug: Tricaprilin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Matching Placebo to AC-1202', 'description': 'Placebo formulation, once daily. Administered orally', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Tricaprilin', 'type': 'DRUG', 'otherNames': ['AC-1202'], 'description': 'Powder formulation will be mixed in a liquid (approximately 8 oz).', 'armGroupLabels': ['AC-1202']}, {'name': 'Placebo', 'type': 'OTHER', 'otherNames': ['Matching placebo to AC-1202'], 'description': 'Powder formulation will be mixed in a liquid (approximately 8 oz).', 'armGroupLabels': ['Matching Placebo to AC-1202']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34613', 'city': 'Brooksville', 'state': 'Florida', 'country': 'United States', 'facility': 'Meridien Research', 'geoPoint': {'lat': 28.55554, 'lon': -82.38991}}, {'zip': '32720', 'city': 'DeLand', 'state': 'Florida', 'country': 'United States', 'facility': 'University Clinical Research-DeLand', 'geoPoint': {'lat': 29.02832, 'lon': -81.30312}}, {'zip': '34102', 'city': 'Naples', 'state': 'Florida', 'country': 'United States', 'facility': 'Anchor Research Center', 'geoPoint': {'lat': 26.14234, 'lon': -81.79596}}, {'zip': '34471', 'city': 'Ocala', 'state': 'Florida', 'country': 'United States', 'facility': 'Renstar Medical Research', 'geoPoint': {'lat': 29.1872, 'lon': -82.14009}}, {'zip': '33024', 'city': 'Pembroke Pines', 'state': 'Florida', 'country': 'United States', 'facility': 'University Clinical Research Center', 'geoPoint': {'lat': 26.00315, 'lon': -80.22394}}, {'zip': '33709', 'city': 'St. Petersburg', 'state': 'Florida', 'country': 'United States', 'facility': 'Meridien Research', 'geoPoint': {'lat': 27.77086, 'lon': -82.67927}}], 'overallOfficials': [{'name': 'Samuel Henderson, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Cerecin'}, {'name': 'Thomas H. Crook III, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Psychologix, Inc.'}, {'name': 'Thomas Hochadel, Pharm.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Advanced Research Corporation'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cerecin', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}