Ignite Creation Date:
2025-12-24 @ 11:29 PM
Ignite Modification Date:
2025-12-31 @ 2:54 AM
Study NCT ID:
NCT07122856
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-08-14
First Post:
2025-08-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Predictive Factors for Initial MMSE Score and Rapid Decline in Alzheimer's Disease Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000544', 'term': 'Alzheimer Disease'}, {'id': 'D060825', 'term': 'Cognitive Dysfunction'}], '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': 'D003072', 'term': 'Cognition Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-09-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2026-03-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-08', 'studyFirstSubmitDate': '2025-08-08', 'studyFirstSubmitQcDate': '2025-08-08', 'lastUpdatePostDateStruct': {'date': '2025-08-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-08-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in MMSE Score Over 12 Months - measured as either a decrease of ≥3 points on the Mini-Mental State Examination [MeSH] or patient institutionalization within 12 months.', 'timeFrame': '12 months'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Alzheimer Disease', 'Mini-Mental State Examination', 'Cognitive Dysfunction', 'Neuropsychological Tests', 'Caregivers']}, 'descriptionModule': {'briefSummary': "This study looks at people with Alzheimer's disease to find out which factors are linked to their initial score on the Mini-Mental State Examination (MMSE) and which factors may predict a fast decline in their score over 12 months. Researchers will review medical records from patients seen at the Memory Clinic of Gonesse Hospital and analyze information such as age, education, medical history, nutrition, mood, and caregiver burden. The goal is to better understand what influences early cognitive performance and how quickly it changes, to help improve patient care and planning."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "The study population consists of all patients who attended the Memory Clinic at CH Gonesse between July 2023 and July 2025. From this group, participants will be selected if they have a confirmed diagnosis of Alzheimer's disease (based on NIAA 2018 or IWG 2021 criteria) and have undergone at least two MMSE assessments spaced 12 months apart. Data will be extracted from medical records and registries within this hospital setting.", 'eligibilityCriteria': "Inclusion Criteria:\n\n* Confirmed diagnosis of Alzheimer's disease according to NIAA 2018 or IWG 2021 criteria\n* At least two MMSE evaluations spaced 12 months apart\n* Follow-up at the Memory Clinic of CH Gonesse\n\nExclusion Criteria:\n\n* Presence of other neurodegenerative diseases (e.g., Frontotemporal Dementia, Multiple System Atrophy, Vascular Dementia, LATE)\n* Patient has moved out of the study area (outside the CH Gonesse territory)"}, 'identificationModule': {'nctId': 'NCT07122856', 'briefTitle': "Predictive Factors for Initial MMSE Score and Rapid Decline in Alzheimer's Disease Patients", 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier de Gonesse'}, 'officialTitle': "Predictive Factors for Initial MMSE Score and Rapid Decline in Alzheimer's Disease Patients", 'orgStudyIdInfo': {'id': '0114_NEUROLOGIE_TARGET MMSE'}}, 'contactsLocationsModule': {'locations': [{'city': 'Gonesse', 'state': 'France', 'country': 'France', 'contacts': [{'name': 'Abdullah Blakime', 'role': 'CONTACT', 'email': 'coordination.rechercheclinique@ghtpdfr.fr', 'phone': '01.34.53.24.64'}], 'facility': 'Centre Hospitalier de Gonesse', 'geoPoint': {'lat': 48.98693, 'lon': 2.44892}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier de Gonesse', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}