Ignite Creation Date:
2025-12-24 @ 6:47 PM
Ignite Modification Date:
2026-01-04 @ 12:39 PM
Study NCT ID:
NCT04967157
Status:
COMPLETED
Last Update Posted:
2025-04-06
First Post:
2021-07-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cognitive Effects of Citicoline on Attention in Healthy Mean and Women
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Canada']}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 148}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-09-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2022-08-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-03', 'studyFirstSubmitDate': '2021-07-08', 'studyFirstSubmitQcDate': '2021-07-08', 'lastUpdatePostDateStruct': {'date': '2025-04-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-07-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-08-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Composite score calculated based on scores from the Computerized Mental Performance Assessment System (COMPASS, Northumbria University, Newcastle upon Tyne, UK) that measure cognitive assessment', 'timeFrame': '12 weeks'}], 'secondaryOutcomes': [{'measure': 'Standardized scores on the Computerized Mental Performance Assessment System (COMPASS, Northumbria University, Newcastle upon Tyne, UK) that measure cognitive assessment', 'timeFrame': '12 weeks'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'The objective of this trial is to determine the effects of citicoline on cognitive performance for attention in healrhy Men and Women compared to a placebo.', 'detailedDescription': "This study is a 12-week, randomized, double-blind, placebo-controlled trial of citicoline in healthy men and women. Cognitive assessments will be performed to determine whether citicoline administration improves attention, compared to placebo administration.\n\n\\*\\*Note: This note is to inform you that the Unique Protocol ID BIO-2104 was unintentionally combined with another Unique Protocol ID, K5-24-01-T0060, resulting in history records that should not be considered as part of the BIO-2104's timeline.\n\nThis explanation has been added per PRS instructions to ensure compliance and maintain data integrity in alignment with the protocol."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '35 Years', 'genderBased': False, 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* male or female, 35-75 years of age\n* Scores ≥ 24 on the MMSE, ≤15 on the CESD-R, and scores below the population median (i.e., below 81.25, above 36.8) on the Gradual CPT\n* Self-reported poor attention\n* no health conditions that would prevent him or her from fulfilling the study requirements on the basis of medical history and routine laboratory test results\n* Understands the study procedures and signs forms providing informed consent to participate in the study and authorizes the release of relevant protected health information to the Principal Investigator.\n\nExclusion Criteria:\n\n* color blindness\n* Known allergy or sensitivity to any of the ingredients in the study products and/or any ingredients of the breakfast meal provided\n* major medical or neurological illness\n* diagnosis of attention deficit hyperactive disorder (ADHD)\n* female who is pregnant, planning to be pregnant during the study period\n* requiring treatment with a drug which might obscure the action of the study treatment'}, 'identificationModule': {'nctId': 'NCT04967157', 'briefTitle': 'Cognitive Effects of Citicoline on Attention in Healthy Mean and Women', 'organization': {'class': 'INDUSTRY', 'fullName': 'Kirin Holdings Company, Limited'}, 'officialTitle': 'A Randomized, Parallel, Double-Blind, Placebo-Controlled Study to Assess the Cognitive Effects of a Citicoline Supplement (Cognizin®) on Attention in Healthy Men and Women', 'orgStudyIdInfo': {'id': 'BIO-2104'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Intervention: Dietary Supplement: Placebo supplement', 'interventionNames': ['Dietary Supplement: Placebo supplement']}, {'type': 'EXPERIMENTAL', 'label': 'Cognizin®', 'description': 'Intervention: Dietary Supplement: Citicoline supplement', 'interventionNames': ['Dietary Supplement: Citicoline supplement']}], 'interventions': [{'name': 'Placebo supplement', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Placebo'], 'description': 'Cellulose', 'armGroupLabels': ['Placebo']}, {'name': 'Citicoline supplement', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Cognizin ®'], 'description': 'Cognizin ®', 'armGroupLabels': ['Cognizin®']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60101', 'city': 'Addison', 'state': 'Illinois', 'country': 'United States', 'facility': 'Biofortis Clinical Research, Inc.', 'geoPoint': {'lat': 41.9317, 'lon': -87.98896}}], 'overallOfficials': [{'name': 'Kathleen Kelley, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Biofortis Clinical Research, Inc. Addison, Illinois, United States, 60101'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kirin Holdings Company, Limited', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Biofortis Clinical Research, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}