Ignite Creation Date:
2025-12-24 @ 9:21 PM
Ignite Modification Date:
2025-12-27 @ 11:33 AM
Study NCT ID:
NCT01315704
Status:
UNKNOWN
Last Update Posted:
2011-03-15
First Post:
2011-03-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Alzheimer's Disease and Related Disorders
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000544', 'term': 'Alzheimer Disease'}, {'id': 'D020235', 'term': 'Gait Apraxia'}, {'id': 'D003072', 'term': 'Cognition Disorders'}], 'ancestors': [{'id': 'D003704', 'term': 'Dementia'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D024801', 'term': 'Tauopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D020233', 'term': 'Gait Disorders, Neurologic'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D001072', 'term': 'Apraxias'}, {'id': 'D011596', 'term': 'Psychomotor Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 700}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2009-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-03', 'completionDateStruct': {'date': '2017-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2011-03-14', 'studyFirstSubmitDate': '2011-03-11', 'studyFirstSubmitQcDate': '2011-03-14', 'lastUpdatePostDateStruct': {'date': '2011-03-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-03-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Spatiotemporal gait parameters', 'timeFrame': 'baseline'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ["Alzheimer's Disease", 'Gait Apraxia', 'Impaired Cognition']}, 'referencesModule': {'references': [{'pmid': '27568453', 'type': 'DERIVED', 'citation': 'Beauchet O, Barden J, Liu-Ambrose T, Chester VL, Annweiler C, Szturm T, Grenier S, Leonard G, Bherer L, Allali G; Canadian Gait Consortium. Anti-Dementia Drugs, Gait Performance and Mental Imagery of Gait: A Non-Randomized Open-Label Trial. Drugs Aging. 2016 Sep;33(9):665-73. doi: 10.1007/s40266-016-0391-0.'}, {'pmid': '24261605', 'type': 'DERIVED', 'citation': 'Beauchet O, Launay CP, Allali G, Watfa G, Gallouj K, Herrmann FR, Annweiler C. Anti-dementia drugs and changes in gait: a pre-post quasi-experimental pilot study. BMC Neurol. 2013 Nov 21;13:184. doi: 10.1186/1471-2377-13-184.'}]}, 'descriptionModule': {'briefSummary': "The purpose of this study is to compare characteristics of gait and balance measured among patients with Alzheimer's disease or related disorders separated into 3 groups according to the stage of disease (i.e., pre-dementia, mild and moderate dementia stages); to determine the effects of anti-dementia drugs and vitamin D on cognitive motor abnormalities; and to establish a database at Angers University Memory Centre.", 'detailedDescription': "Although gait disorders are frequently associated with Alzheimer's disease and related disorders (ADRD), few studies have focused on cognitive motor effects of anti-dementia drugs and vitamin D.\n\nThe objectives of this study are to\n\n* Compare characteristics of gait and balance measured among patients with ADRD separated into 3 groups according to stages of disease (i.e., pre-dementia, mild and moderate dementia stages)\n* To determine the effects of anti-dementia drugs and vitamin D on cognitive motor abnormalities\n* To determine whether motor abnormalities could be associated with cognitive impairments, specifically executive dysfunctions\n* To establish a database at Angers University Memory Center."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'All patients of the University Memory Center of Angers University Hospital with respect to the eligibility criteria', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All elderly patients from the University Memory Center of Angers University Hospital.\n* Able to walk without any walking aid on 15 meters\n* Mini-Mental Status Examination score \\> 10\n* Being affiliated to a social security regime\n\nExclusion Criteria:\n\n* Mini-Mental Status Examination score ≤ 10\n* Subject suffering from pre-existing impellent disturbances\n* History of cerebrovascular accident or other cerebro-spinal pathology\n* Poor workmanship of the written or oral French language\n* Use of walking aid such as walking frame with wheels or tricycle.\n* Acute medical or surgical disease in the past 3 months\n* Refusal to participate (or trustworthy person)\n* Near visual acuity \\< 2/10'}, 'identificationModule': {'nctId': 'NCT01315704', 'acronym': 'MERE', 'briefTitle': "Alzheimer's Disease and Related Disorders", 'organization': {'class': 'OTHER_GOV', 'fullName': 'University Hospital, Angers'}, 'officialTitle': "Maladie d'Alzheimer et Maladies apparentées : Caractérisation Des Anomalies Cognitivo-motrices, et Des Effets Des médicaments Anti-démence et de la Vitamine D à Partir de la Mise en Place d'Une Base de données au CMRR du CHU d'Angers", 'orgStudyIdInfo': {'id': '2009-15'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group 1', 'description': 'Patients with Mild Cognitive Impairment', 'interventionNames': ['Drug: Drug intervention']}, {'label': 'Group 2', 'description': "Patients with Mild Alzheimer's disease or related disorders", 'interventionNames': ['Drug: Drug intervention']}, {'label': 'Group 3', 'description': "Patients with Moderate Alzheimer's disease or related disorders", 'interventionNames': ['Drug: Drug intervention']}], 'interventions': [{'name': 'Drug intervention', 'type': 'DRUG', 'otherNames': ['Anti-dementia drugs and/or vitamin D'], 'description': 'before-after interventional (anti-dementia drugs and/or vitamin D) study', 'armGroupLabels': ['Group 1', 'Group 2', 'Group 3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '49933', 'city': 'Angers', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Cedric ANNWEILER, MD', 'role': 'CONTACT', 'email': 'ceannweiler@chu-angers.fr', 'phone': '(+33)241354725'}], 'facility': 'Cédric ANNWEILER , MD', 'geoPoint': {'lat': 47.47156, 'lon': -0.55202}}], 'centralContacts': [{'name': 'Cedric ANNWEILER, DM', 'role': 'CONTACT', 'email': 'ceannweiler@chu-angers.fr', 'phone': '(+33) 241354725'}], 'overallOfficials': [{'name': 'Cedric ANNWEILER, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Memory Centre of Angers University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Angers', 'class': 'OTHER_GOV'}, 'responsibleParty': {'oldNameTitle': 'Cédric ANNWEILER ; MD', 'oldOrganization': 'Memory Centre of Angers University Hospital'}}}}