Ignite Creation Date:
2025-12-24 @ 11:45 PM
Ignite Modification Date:
2026-02-22 @ 1:08 PM
Study NCT ID:
NCT05642351
Status:
RECRUITING
Last Update Posted:
2024-09-19
First Post:
2022-11-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Autobiographical Specificity
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000544', 'term': 'Alzheimer Disease'}, {'id': 'D057180', 'term': 'Frontotemporal Dementia'}], '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': 'D057174', 'term': 'Frontotemporal Lobar Degeneration'}, {'id': 'D057177', 'term': 'TDP-43 Proteinopathies'}, {'id': 'D057165', 'term': 'Proteostasis Deficiencies'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 62}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-02-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2025-12-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-09-12', 'studyFirstSubmitDate': '2022-11-22', 'studyFirstSubmitQcDate': '2022-11-30', 'lastUpdatePostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-12-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Autobiographical specificity', 'timeFrame': '40 minutes', 'description': 'We will apply the method by Raes et al. (2007) to assess whether each retrieved event refers to a: specific event, categorical event, extended event, or semantic event'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Autobiographical memory', "Alzheimer's disease", 'with behavioral variant of frontotemporal dementia'], 'conditions': ['Memory', 'Alzheimer Disease', 'Frontotemporal Dementia']}, 'descriptionModule': {'briefSummary': "Autobiographical memory is diminished in patients with Alzheimer's Disease and those with behavioral variant of frontotemporal dementia, and research has focused on the hampered ability of patients in retrieving specific memories. However, this study proposes a detailed methodology to provide a qualitative analysis of autobiographical specificity.", 'detailedDescription': "Patients with Alzheimer's Disease and those with behavioral variant of frontotemporal dementia will be invited to retrieve autobiographical memories. Memories will be analyzed and categorized into specific, categoric, extended, or semantic autobiographical retrieval."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All participants will be recruited through the active file of memory consultations of the "memory resource and research center" (CMRR) of the Nantes University Hospital.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Alzheimer' disease or avioral variant of frontotemporal dementia\n* No opposition from the patient to be included in the study\n* For Alzheimer's patients: a score of more than 24 out of 30 on the Mini Mental State Examination (McKhann et al., 1984)\n\nExclusion Criteria:\n\n* Other psychiatric/neurological disorders\n* Minor patients\n* Adults under guardianship or protection."}, 'identificationModule': {'nctId': 'NCT05642351', 'acronym': 'ESAD', 'briefTitle': 'Autobiographical Specificity', 'organization': {'class': 'OTHER', 'fullName': 'Nantes University Hospital'}, 'officialTitle': "Autobiographical Specificity in Alzheimer's Disease and Behavioral Variant Frontotemporal Dementia", 'orgStudyIdInfo': {'id': 'RC22_0626'}}, 'armsInterventionsModule': {'armGroups': [{'label': "Alzheimer's Disease", 'description': 'recruited according to criteria by National Institute on Aging (McKhann et al., 2011).', 'interventionNames': ['Other: Autobiographical reminder']}, {'label': 'Behavioral variant of frontotemporal dementia', 'description': 'recruited following criteria by Rascovsky et al. (2011)', 'interventionNames': ['Other: Autobiographical reminder']}], 'interventions': [{'name': 'Autobiographical reminder', 'type': 'OTHER', 'description': 'The analysis of the specificity of Autobiographical Recall will be done through the following scale, developed for the study:\n\n* 6 points for a recall involving a single personal event located in space AND time (e.g.,"I remember when my parents took me to the sea for the first time..in 1962..in Dunkerque")\n* 5 points for a recall involving a single personal event located in space OR time ("I remember when my parents first took me to the sea...in 1962")\n* 4 points for a recall involving a single personal event but without spatial/temporal details ("I remember when my parents took me to the sea for the first time")\n* 3 points for a recall involving a general personal event but located in space AND time ("we used to go to Dunkerque in the summer")\n* 2 points for a recall involving a general personal event but located in space OR time ("we used to go to Dunkerque")\n* 1 point for a recall involving a general personal event without spatial/temporal details ("we used to go on vacation")', 'armGroupLabels': ["Alzheimer's Disease", 'Behavioral variant of frontotemporal dementia']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Nantes', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Mohamad EL HAJ', 'role': 'CONTACT', 'email': 'mohamad.elhaj@univ-nantes.fr', 'phone': '02 40 68 66 60'}, {'name': 'Mohamad EL HAJ', 'role': 'CONTACT'}, {'name': 'Claire BOUTOLEAU BRETONNIERE', 'role': 'CONTACT'}], 'facility': 'EL HAJ Mohamad', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}], 'centralContacts': [{'name': 'Mohamad EL HAJ', 'role': 'CONTACT', 'email': 'mohamad.elhaj@univ-nantes.fr', 'phone': '02 40 68 66 60'}, {'name': 'Claire Boutoleau Bretonnière', 'role': 'CONTACT', 'email': 'claire.boutoleaubretonniere@chu-nantes.fr', 'phone': '02 40 16 57 05'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nantes University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}