Ignite Creation Date:
2025-12-24 @ 4:26 PM
Ignite Modification Date:
2026-02-23 @ 12:19 PM
Study NCT ID:
NCT02705066
Status:
COMPLETED
Last Update Posted:
2019-05-23
First Post:
2016-02-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Citicoline Effects on Cortical Membrane Structure and Function
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 61}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2018-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-05-21', 'studyFirstSubmitDate': '2016-02-23', 'studyFirstSubmitQcDate': '2016-03-06', 'lastUpdatePostDateStruct': {'date': '2019-05-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-03-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Baseline red blood cell (RBC) omega-3 fatty acid (EPA+DHA) levels', 'timeFrame': 'Baseline'}], 'primaryOutcomes': [{'measure': 'Phosphodiester (PDE) concentrations in the ACC by 31P-MRS', 'timeFrame': '6 weeks'}, {'measure': 'b-NTP concentrations in the ACC by 31P-MRS', 'timeFrame': '6 weeks'}], 'secondaryOutcomes': [{'measure': 'Blood oxygenation level-dependent signal in the ACC during sustained attention by fMRI', 'timeFrame': '6 weeks'}, {'measure': 'Reaction time (ms) on an attention task (CPT-IP)', 'timeFrame': '6 weeks'}, {'measure': 'Accuracy (percent correct) on an attention task (CPT-IP)', 'timeFrame': '6 weeks'}]}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'The goal of this project is to determine the effects of 6-week dietary supplementation with one of two doses of citicoline (250 mg/d, 500 mg/d) or placebo on prefrontal cortical membrane dynamics (31P-MRS) and event-related functional activation (fMRI) in healthy middle-aged adults.', 'detailedDescription': 'To determine the effect of citicoline supplementation on cortical structure and function in healthy middle-aged adults. Test 1: The effect of citicoline (500 mg/d) compared with placebo on event-related anterior cingulate cortex (ACC) activation during sustained attention by fMRI. Test 2: The effect of citicoline (500 mg/d) compared with placebo on reaction time and increasing accuracy on the sustained attention task (CPT-IP). Test 3: The effect of citicoline compared with placebo on phosphodiester (PDE) and b-NTP levels in the ACC by 31P-MRS. Test 4: ACC activation and CPT-IP performance (fMRI) and ACC PDE levels (31P-MRS) following high-dose citicoline (500 mg/d) compared with placebo at Week 3. Test 5: The effect of low-dose citicoline (250 mg/d) compared with placebo on an ACC activation and CPT-IP performance (fMRI) and ACC PDE levels (31P-MRS). Test 6: Among all subjects (n=60), the relationship between baseline red blood cell (RBC) omega-3 fatty acid (EPA+DHA) levels and ACC activation, ACC PDE levels, or the effects of citicoline.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '40 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Provision of written informed consent;\n* Ages 40-60 years old;\n* Right handed.\n* If female, not pregnant (as determined by a positive pregnancy test); and agrees to use one of the following methods of birth control: abstinence from sexual intercourse, barrier (diaphragm or condom), or oral/injectable contraceptive;\n\nExclusion Criteria:\n\n* Contraindication to an MRI scan (i.e., braces, claustrophobia, pacemaker etc);\n* A history of a major medical (e.g., diabetes) or neurological illness (e.g., epilepsy);\n* Body mass index (BMI) ≥ 30;\n* An IQ \\<75 and \\>130;\n* A positive urine drug test (nicotine dependence is permitted);\n* Personal history of a DSM-5 Axis I psychiatric disorder;\n* Requiring treatment with a drug which might obscure the action of the study treatment.'}, 'identificationModule': {'nctId': 'NCT02705066', 'briefTitle': 'Citicoline Effects on Cortical Membrane Structure and Function', 'organization': {'class': 'INDUSTRY', 'fullName': 'Kyowa Hakko Bio Co., Ltd.'}, 'officialTitle': 'Citicoline Effects on Cortical Membrane Structure and Function', 'orgStudyIdInfo': {'id': '2015-8400'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo (Cellulose)', 'interventionNames': ['Dietary Supplement: Placebo supplement']}, {'type': 'EXPERIMENTAL', 'label': 'Cognizin 250 mg/day', 'interventionNames': ['Dietary Supplement: Citicoline supplement']}, {'type': 'EXPERIMENTAL', 'label': 'Cognizin 500 mg/day', 'interventionNames': ['Dietary Supplement: Citicoline supplement']}], 'interventions': [{'name': 'Citicoline supplement', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Cognizin'], 'armGroupLabels': ['Cognizin 250 mg/day', 'Cognizin 500 mg/day']}, {'name': 'Placebo supplement', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Placebo'], 'description': 'Cellulose', 'armGroupLabels': ['Placebo (Cellulose)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'University of Cincinnati', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kyowa Hakko Bio Co., Ltd.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'University of Cincinnati', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}