Ignite Creation Date:
2025-12-25 @ 2:49 AM
Ignite Modification Date:
2025-12-26 @ 1:31 AM
Study NCT ID:
NCT06354933
Status:
COMPLETED
Last Update Posted:
2024-04-15
First Post:
2024-04-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Neurological Soft Signs in Neurodegenerative Dementias
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000544', 'term': 'Alzheimer Disease'}, {'id': 'D020961', 'term': 'Lewy Body Disease'}, {'id': 'D057180', 'term': 'Frontotemporal Dementia'}, {'id': 'D000088282', 'term': 'Corticobasal Degeneration'}], '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': 'D020734', 'term': 'Parkinsonian Disorders'}, {'id': 'D001480', 'term': 'Basal Ganglia Diseases'}, {'id': 'D009069', 'term': 'Movement Disorders'}, {'id': 'D000080874', 'term': 'Synucleinopathies'}, {'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': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 186}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2024-02-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-04-11', 'studyFirstSubmitDate': '2024-04-03', 'studyFirstSubmitQcDate': '2024-04-03', 'lastUpdatePostDateStruct': {'date': '2024-04-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-11-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Difference in NSS', 'timeFrame': '0 days (baseline)', 'description': 'Difference in Neurological Soft Signs according to the Heidelberg manual between neurodegenerative dementias and controls (range 0-48, higher scores indicate worse performance)'}], 'secondaryOutcomes': [{'measure': 'Association between NSS and Neuropsychiatric Inventory (NPI) scores', 'timeFrame': '0 days (baseline)', 'description': 'Correlation between NSS and NPI (range 0-144) (higher values indicate better correlation)'}, {'measure': 'Correlation between NSS scores and cognitive function assessed by Mini-Mental State Examination (MMSE)', 'timeFrame': '0 days (baseline)', 'description': 'Correlation between NSS and MMSE (range 0-30) (higher values indicate better correlation)'}, {'measure': 'Correlation between NSS scores and cognitive function assessed by Frontal Assessment Battery (FAB)', 'timeFrame': '0 days (baseline)', 'description': 'Correlation between NSS and FAB (range 0-18) (higher values indicate better correlation)'}, {'measure': 'Longitudinal changes in NSS scores', 'timeFrame': '12 months', 'description': 'Longitudinal differences in NSS scores in subjects with neurodegenerative dementia (range 0-48) (higher scores indicate worse performance)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Alzheimer Disease', 'Dementia With Lewy Bodies', 'Frontotemporal Dementia', 'Corticobasal Degeneration']}, 'descriptionModule': {'briefSummary': "The goal of this observational study is to investigate the prevalence of Neurological Soft Signs (NSS) in various categories of dementia patients compared to matched controls. The main questions it aims to answer are:\n\n* Does the prevalence of NSS significantly differ among patients with neurodegenerative dementias compared to controls?\n* Are NSS associated with neuropsychiatric alterations in dementia patients?\n* Do NSS correlate with cognitive screening tools?\n* Do NSS increase over time in patients with neurodegenerative dementias?\n\nParticipants will undergo assessments including:\n\n* Evaluation of NSS using the Heidelberg scale\n* Neuropsychiatric assessments\n* Cognitive screening using the Mini-Mental State Examination (MMSE) and Frontal Assessment Battery (FAB)\n\nResearchers will compare dementia groups (Alzheimer's disease, Frontotemporal dementia, Corticobasal syndrome and Lewy body dementia) to controls to determine differences in NSS prevalence. Additionally, associations between NSS and neuropsychiatric symptoms, as well as cognitive performance, will be explored."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': "The study will include individuals diagnosed with Alzheimer's Disease (AD), Frontotemporal Dementia (FTD), Corticobasal Syndrome (CBS), or Lewy Body Dementia (LBD), along with age and gender-matched controls without dementia. Controls will be recruited from caregivers and companions of patients attending other neurological clinics. All participants will undergo thorough neurological and neuropsychiatric assessments to confirm eligibility and evaluate outcomes.", 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Diagnosis of probable Alzheimer's Disease (AD), Frontotemporal Dementia (FTD), Corticobasal Syndrome (CBS), or probable Lewy Body Dementia (LBD) according to established clinical criteria.\n* MMSE score greater than 10.\n* Age and gender-matched controls without a history of neurological or psychiatric conditions.\n\nExclusion Criteria:\n\n* Mixed dementia or vascular etiology.\n* History of neurological or psychiatric conditions predating the dementia diagnosis.\n* Substance or alcohol abuse history.\n* Known comorbidities affecting neurological or psychiatric function.\n* MMSE score less than or equal to 10.\n* Inability to provide informed consent."}, 'identificationModule': {'nctId': 'NCT06354933', 'acronym': 'DemeNSS', 'briefTitle': 'Neurological Soft Signs in Neurodegenerative Dementias', 'organization': {'class': 'OTHER', 'fullName': 'University of Milano Bicocca'}, 'officialTitle': 'Neurological Soft Signs in Neurodegenerative Dementias', 'orgStudyIdInfo': {'id': 'DemeNSS (3785)'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Neurodegenerative dementias', 'description': "Subjects with either Alzheimer's disease, frontotemporal dementia, dementia with Lewy bodies or corticobasal syndrome", 'interventionNames': ['Diagnostic Test: Neurological Soft Signs']}, {'label': 'Control', 'description': 'Subjects without dementia', 'interventionNames': ['Diagnostic Test: Neurological Soft Signs']}], 'interventions': [{'name': 'Neurological Soft Signs', 'type': 'DIAGNOSTIC_TEST', 'description': 'Neurological Soft Signs score according to the Heidelberg Manual', 'armGroupLabels': ['Control', 'Neurodegenerative dementias']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20900', 'city': 'Monza', 'state': 'Lombardy', 'country': 'Italy', 'facility': 'Fondazione IRCCS San Gerardo dei Tintori', 'geoPoint': {'lat': 45.58005, 'lon': 9.27246}}], 'overallOfficials': [{'name': 'Lucio Tremolizzo, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Milano Bicocca'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Milano Bicocca', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}