Ignite Creation Date:
2025-12-26 @ 10:37 AM
Ignite Modification Date:
2026-01-13 @ 12:42 PM
Study NCT ID:
NCT01993628
Status:
UNKNOWN
Last Update Posted:
2013-11-25
First Post:
2013-10-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Construction-LBD (Constructional Apraxia in Alzheimer's Disease (AD) and Lewy Body's Dementia (LBD))
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000544', 'term': 'Alzheimer Disease'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-11', 'completionDateStruct': {'date': '2016-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-11-18', 'studyFirstSubmitDate': '2013-10-31', 'studyFirstSubmitQcDate': '2013-11-18', 'lastUpdatePostDateStruct': {'date': '2013-11-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-11-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Score obtained at the Rey figure test with a planning strategy help by LBD patients compared to the score obtained by AD patients.', 'timeFrame': 'At inclusion'}]}, 'conditionsModule': {'conditions': ["Alzheimer's Disease", "Lewy Body's Dementia"]}, 'descriptionModule': {'briefSummary': 'Alzheimer\'s disease (AD) and Lewy body\'s dementia (LBD) are two frequent neurodegenerative pathologies. They differ in their expression, their evolution but share same features which make their diagnosis uneasy.\n\nConstructional apraxia has been described in both disease.The underlying mechanisms have been less studied and could be different in AD and LBD.\n\nThe definition of the constructional apraxia is purely descriptive and few models are inconclusive.\n\nIt is admitted that drawing tasks involve visuo-perceptive and visuo-spatial abilities, executive functions and working memory as well as purely "constructive" skills.\n\nRegarding to different studies, visuo-perceptive abilities are more severely impaired in LBD than in AD and are considered as an early onset sign of the disease.\n\nExecutive functions deficits are documented in AD and LDB and could contribute to the drawing impairment.\n\nIt is possible to compensate the planning disorders in giving patient the best strategy to use.\n\nIf drawing impairment persists, they should result of others mechanisms like visuo-perception, visuo-spatial or constructive deficits.\n\nThe investigators suggest that giving the best planning strategy will help more AD patients who are supposed to fail in raison of an executive impairment, than the LDB group who is supposed to present visuo-perceptive deficits. An MRI will be proposed to study the cerebral areas involved in constructional apraxia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '45 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Alzheimer's disease or Lewy bodies dementia\n* ≥ 45 years\n* the cognitive impairment is mild to moderate\n* French speaker\n* a caregiver is present\n* An informed consent is signed by the patient and the p.i.\n\nExclusion Criteria:\n\n* MRI contraindication\n* Other neurological disease (FTD, brain tumor, vascular disease…)\n* Psychiatric disease (Schizophrenia, major depression, psychotic disorders, melancholia…)\n* Patient who doesn't want to be informed in case of the discovery of an abnormality\n* View or audition deficits, or motor disability which can interfere with the cognitive testing\n* Patient participating to an exclusive protocol or in the period of exclusion\n* Pregnant woman\n* Person under an administrative or legal measure of liberty privation\n* Person under a legal measure of protection or under administrative supervision\n* Person unable to give his consent"}, 'identificationModule': {'nctId': 'NCT01993628', 'briefTitle': "Construction-LBD (Constructional Apraxia in Alzheimer's Disease (AD) and Lewy Body's Dementia (LBD))", 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Strasbourg, France'}, 'officialTitle': "Constructional Apraxia in Alzheimer's Disease (AD) and Lewy Body's Dementia (LBD)", 'orgStudyIdInfo': {'id': '5565'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': "Alzheimer's disease (AD)", 'description': 'Rey figure test and MRI', 'interventionNames': ['Other: Rey figure test', 'Other: MRI']}, {'type': 'EXPERIMENTAL', 'label': "Lewy body's dementia (LBD)", 'description': 'Rey figure test and MRI', 'interventionNames': ['Other: Rey figure test', 'Other: MRI']}], 'interventions': [{'name': 'Rey figure test', 'type': 'OTHER', 'armGroupLabels': ["Alzheimer's disease (AD)", "Lewy body's dementia (LBD)"]}, {'name': 'MRI', 'type': 'OTHER', 'armGroupLabels': ["Alzheimer's disease (AD)", "Lewy body's dementia (LBD)"]}]}, 'contactsLocationsModule': {'locations': [{'city': 'Strasbourg', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Xavier De Pétigny, Docteur', 'role': 'CONTACT', 'email': 'xavier.depetigny@chru-strasbourg.fr', 'phone': '3 88 12 79 25', 'phoneExt': '0033'}], 'facility': 'Hôpitaux Universitaires de Strasbourg', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}], 'centralContacts': [{'name': 'Xavier DE PETIGNY, Docteur', 'role': 'CONTACT', 'email': 'xavier.depetigny@chru-strasbourg.fr', 'phone': '3 88 11 56 24', 'phoneExt': '0033'}, {'name': 'PHILLIPPS Clelie, Ingenior', 'role': 'CONTACT', 'email': 'clelie.phillipps@chru-strasbourg.fr', 'phone': '3 88 12 79 25', 'phoneExt': '0033'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Strasbourg, France', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}