Ignite Creation Date:
2025-12-24 @ 3:49 PM
Ignite Modification Date:
2025-12-28 @ 12:11 PM
Study NCT ID:
NCT01160692
Status:
COMPLETED
Last Update Posted:
2010-08-02
First Post:
2009-10-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Evaluate The Effects Of a Multivitamin/Mineral With Ginko In Subjects With Age Associated Memory Impairment
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': 'C067316', 'term': 'Geritol'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 132}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-07', 'completionDateStruct': {'date': '2008-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-07-30', 'studyFirstSubmitDate': '2009-10-08', 'studyFirstSubmitQcDate': '2010-07-09', 'lastUpdatePostDateStruct': {'date': '2010-08-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-07-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The effect of the multi-vitamin/-mineral preparation containing gingko on major aspects of human cognitive function employing a computerized cognitive assessment system.', 'timeFrame': 'From baseline up to 12 weeks'}], 'secondaryOutcomes': [{'measure': 'The effects of the multi-vitamin/-mineral preparation containing gingko on subjective memory using questionnaires.', 'timeFrame': 'From baseline up to 12 weeks'}, {'measure': 'Tolerance of the daily oral intake of the multi-vitamin/-mineral preparation containing gingko.', 'timeFrame': 'From baseline up to 14 weeks'}, {'measure': 'The effects of the multi-vitamin/-mineral preparation containing gingko on mood using questionnaires.', 'timeFrame': 'From baseline up to 12 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Memory', 'Cognitive Function', 'Elderly', 'Gingko', 'Age Associated Memory Impairment (AAMI)'], 'conditions': ['Age-Related Memory Disorders']}, 'descriptionModule': {'briefSummary': 'A Study to evaluate the cognitive effects and tolerance of a Multi-Vitamin/Mineral Preperation containing Gingko in elderly subjects with age associated memory impairment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Subject is generally healthy (includes subjects presenting with mild chronic diseases where the disease and/or the pharmacological treatment does not result in psychomotor impairment or improvement).\n* Subject is of either gender, and 60+ years of age, inclusive.\n* Subject demonstrates Age Associated Memory Impairment after completion of the CDR test battery and comparison to normative data.\n* Female subject who is post-menopausal.\n* Subject is able to understand the study instructions and has given written informed consent prior to study participation.\n* Subject admitted to this study is oriented to person, place and time and has the ability to communicate with the study staff.\n* Subject is, in the opinion of the study staff, motivated to participate and complete the study as instructed.\n* Subject is willing to be attend visits in a well-rested state.\n\nExclusion Criteria:\n\n* Subject has participated in an interventional study within the one month prior to screening.\n* Intake within three months prior to screening, or intended intake during the study, of one of the following: Ginkgo biloba, St John's Wort, Ginseng, Gotu Kola (Indian Pennywort), or daily doses of vitamin E (-tocopherol) above 30 mg, folic acid above 400 g, vitamins B-1 (thiamine), B-2 (riboflavin), B-6 (pyridoxine) above 2 mg, or other cognition enhancers.\n* Subject has a history of a psychological illness or condition such as to interfere with the subject's ability to understand the requirements of the study.\n* Subject has a history of Alzheimers disease, dementia, mental retardation, Morbus Parkinson, or any other mental disorders.\n* Subject has not been diagnosed with AAMI after completion of the CDR test battery and comparison to normative data.\n* Subject has a history of any bleeding/coagulation disorder (e.g., haemophilia, Protein C or S deficiency).\n* Subject is taking/being treated with a concomitant medication which may affect/inhibit blood coagulation (e.g., warfarin, aspirin, heparin).\n* Subject has history of relevant vascular disorders (e.g., carotid stenosis, stroke, PRIND, coronary artery disease, peripheral vascular disease, thrombosis).\n* Subject has Body Mass Index (BMI) above 40 kg/m2 (severely obese).\n* Subject smokes more than 15 cigarettes, or equivalent daily.\n* Subject has moderate-to-severe hepatic impairment.\n* Subject has history of alcohol or drug abuse.\n* Subject has known allergies or intolerance to any ingredients in the study preparations.\n* Subject is intending to undergo surgery during or immediately upon completion (within two weeks) of study participation."}, 'identificationModule': {'nctId': 'NCT01160692', 'briefTitle': 'A Study to Evaluate The Effects Of a Multivitamin/Mineral With Ginko In Subjects With Age Associated Memory Impairment', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bayer'}, 'officialTitle': 'A Randomized, Placebo-controlled, Parallel Group, Double Blind Study to Evaluate the Cognitive Effects and Tolerance of a Multi-Vitamin/Mineral Preparation Containing Gingko in Elderly Subjects With Age Associated Memory Impairment', 'orgStudyIdInfo': {'id': '11954'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm 1', 'interventionNames': ['Dietary Supplement: Multivitamin/Multimineral/Ginkgo (BAY 81-2775)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Arm 2', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Multivitamin/Multimineral/Ginkgo (BAY 81-2775)', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Multivitamin/Multimineral/Ginkgo (BAY 81-2775), daily oral intake of film coated tablets for 3 months', 'armGroupLabels': ['Arm 1']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Daily oral intake of matching placebo tablets for 3 months', 'armGroupLabels': ['Arm 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'NE1 8ST', 'city': 'Newcastle upon Tyne', 'country': 'United Kingdom', 'geoPoint': {'lat': 54.97328, 'lon': -1.61396}}], 'overallOfficials': [{'name': 'Bayer Study Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bayer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bayer', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Therapeutic Area Head', 'oldOrganization': 'Bayer Healthcare AG'}}}}