Ignite Creation Date:
2025-12-24 @ 5:36 PM
Ignite Modification Date:
2026-03-04 @ 7:00 AM
Study NCT ID:
NCT06855368
Status:
RECRUITING
Last Update Posted:
2025-03-03
First Post:
2025-01-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Biomarkers for Monitoring Dementia Progression
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000544', 'term': 'Alzheimer Disease'}, {'id': 'D000090862', 'term': 'Neuroinflammatory Diseases'}], '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': 'D007249', 'term': 'Inflammation'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-05-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-28', 'studyFirstSubmitDate': '2025-01-29', 'studyFirstSubmitQcDate': '2025-02-28', 'lastUpdatePostDateStruct': {'date': '2025-03-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-03-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-05-17', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Identification of Disease-Associated Phenotypes in MCI and AD', 'timeFrame': 'through study completion, an average of 1 year'}, {'measure': 'Identification of Disease-Associated Early Interventions in MCI and AD', 'timeFrame': 'through study completion, an average of 1 year'}, {'measure': 'Predictive Power of EEG-Based Brain Network Analyses for MCI to AD Conversion', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'EEG power spectral density'}, {'measure': 'Evaluation of Targeting Efficiency of Activated vs Native Leukosomes in Brain Inflammation', 'timeFrame': 'through study completion, an average of 1 year'}, {'measure': 'Evaluation Trafficking Kinetics of Activated vs Native Leukosomes in Brain Inflammation', 'timeFrame': 'through study completion, an average of 1 year'}, {'measure': 'Assessment of Activated Leukosomes in Inducing Anti-Inflammatory Polarization of Macrophages', 'timeFrame': 'through study completion, an average of 1 year'}, {'measure': 'Assessment of Activated Leukosomes in Glial Cells', 'timeFrame': 'through study completion, an average of 1 year'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['EEG', 'functional connectivity', 'neuroinflammation', 'nanoparticles'], 'conditions': ['Alzheimer Disease']}, 'descriptionModule': {'briefSummary': "The variable course of Alzheimer's disease (AD) and the paucity of adequate cures urges to implement new strategies for its early detection and clinical intervention. Studying the etiopathogenesis and pathophysiological mechanisms of AD is a necessary prerequisite for the development of new biomarkers and innovative therapies. Contrarily to anatomical structures, cortical connectivity networks are already deteriorated in early AD and could be a reliable marker of early cognitive decline. Our aim is to characterize the neurophysiological parameters in mild AD, in patients with mild cognitive impairment and in matched healthy subjects to identify discriminating criteria. Concurrently, the study of AD onset and progression in a mouse model, will allow evaluating the causal effect of inflammation on disease progression and to develop a new class of biomimetic anti-inflammatory nanoparticles formulated to have the intrinsic ability to induce brain's activated microglia to an M2 phenotype."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '100 AD and 100 MCI individuals from the dementia clinical centres of North Sardinia and local sections of patients¿ associations and 100 HC will be recruited for the study. To investigate past/present health status and medications, baseline medical screening will be performed by general clinical and anthropometric examinations', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* mild AD and patients with mild cognitive impairment (MCI).\n\nExclusion Criteria:\n\n* major psychosis, genetic, metabolic and other neurological disorders, acute or chronic non-compensated medical illness\n* any medical or drug-related condition affecting cognitive or mood status\n* history or current alcohol/illicit drug abuse.'}, 'identificationModule': {'nctId': 'NCT06855368', 'acronym': 'ADvance', 'briefTitle': 'Biomarkers for Monitoring Dementia Progression', 'organization': {'class': 'OTHER', 'fullName': 'IRCCS San Raffaele Roma'}, 'officialTitle': "Brain Connectivity and Complexity Parameters to Monitor Disease Progression in Dementia Patients and Antiinflammatory Nanotherapeutics in a Preclinical Model of Alzheimer's Disease", 'orgStudyIdInfo': {'id': 'RP 22/25'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'AD'}, {'label': 'MCI'}, {'label': 'HC'}]}, 'contactsLocationsModule': {'locations': [{'zip': '00163', 'city': 'Roma', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'Italy', 'facility': 'IRCCS San Raffaele', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}, {'zip': '07100', 'city': 'Sassari', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Franca Deriu', 'role': 'CONTACT', 'email': 'franca.deriu@ss.omceo.it', 'phone': '079228289'}, {'name': 'Franca Deriu', 'role': 'CONTACT'}, {'name': 'Franca Deriu', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Azienda Ospedaliero-Universitaria di Sassari', 'geoPoint': {'lat': 40.72586, 'lon': 8.55552}}], 'centralContacts': [{'name': 'Lucia Gatta, PhD', 'role': 'CONTACT', 'email': 'lucia.gatta@sanraffaele.it', 'phone': '+390652253440'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'IRCCS San Raffaele Roma', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}