[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100598767":3},{"organization":4,"armGroups":7,"interventions":26,"overallOfficials":39,"centralContacts":44,"locations":50,"responsibleParty":86,"collaborators":88,"id":91,"slug":32,"hasResults":92,"nctId":93,"briefTitle":94,"officialTitle":95,"acronym":96,"eligibilityCriteria":97,"healthyVolunteers":92,"sex":98,"minAge":99,"maxAge":100,"enrollmentInfo":101,"targetDuration":32,"studyType":104,"phases":105,"briefSummary":107,"conditions":108,"keywords":110,"overallStatus":52,"whyStopped":32,"lastUpdateSubmitDate":117,"lastUpdatePostDateStruct":118,"startDateStruct":121,"completionDateStruct":123,"leadSponsor":125,"locationsCount":126},{"fullName":5,"class":6},"I.R.C.C.S. Fondazione Santa Lucia","OTHER",[8,14,20],{"label":9,"type":10,"description":11,"interventionNames":12},"combined iTBS-tACS","EXPERIMENTAL","32 sessions of combined iTBS-tACS (5 times\u002Fweek for 2 weeks -intensive phase-; 1 time\u002Fweek for 22 weeks -maintenance phase-)",[13],"Device: Combined iTBS-tACS",{"label":15,"type":16,"description":17,"interventionNames":18},"iTBS-sham tACS","ACTIVE_COMPARATOR","32 sessions of combined iTBS-sham tACS (5 times\u002Fweek for 2 weeks -intensive phase-; 1 time\u002Fweek for 22 weeks -maintenance phase-)",[19],"Device: iTBS-sham tACS",{"label":21,"type":22,"description":23,"interventionNames":24},"sham iTBS- sham tACS","PLACEBO_COMPARATOR","32 sessions of sham iTBS- sham tACS (5 times\u002Fweek for 2 weeks -intensive phase-; 1 time\u002Fweek for 22 weeks -maintenance phase-)",[25],"Device: sham iTBS- sham tACS",[27,33,36],{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"DEVICE","Combined iTBS-tACS","The iTBS-tACS will be applied over the precuneus and last for 190 s, with the tACS electrode positioned on the scalp and the iTBS coil positioned just above it. The iTBS protocol will consist of 600 pulses, delivered in 20 trains of 10 bursts with an interval of 8 seconds between each train. Each burst consists of three pulses at 50Hz, repeated at 5Hz. The total duration will therefore be 190 seconds. iTBS and tACS will be synchronized using a BrainTrigger and SIGNAL Software so that both stimulations will start simultaneously",[9],null,{"type":28,"name":15,"description":34,"armGroupLabels":35,"otherNames":32},"The iTBS-tACS will be applied over the precuneus and last for 190 s, with the tACS electrode positioned on the scalp and the iTBS coil positioned just above it. The iTBS protocol will consist of 600 pulses, delivered in 20 trains of 10 bursts with an interval of 8 seconds between each train. Each burst consists of three pulses at 50Hz, repeated at 5Hz. The total duration will therefore be 190 seconds.\n\nFor the tACS sham condition, the electric current will not be applied, but there will be a 2 s 1 mA ramp up and 2 s 1 mA ramp down, to give the participant real stimulation feelings.",[15],{"type":28,"name":21,"description":37,"armGroupLabels":38,"otherNames":32},"The iTBS-tACS will be applied over the precuneus and last for 190 s, with the tACS electrode positioned on the scalp and the iTBS coil positioned just above it. The iTBS protocol will consist of 600 pulses, delivered in 20 trains of 10 bursts with an interval of 8 seconds between each train. Each burst consists of three pulses at 50Hz, repeated at 5Hz. The total duration will therefore be 190 seconds.\n\nFor the iTBS sham condition, stimulation was delivered with the coil angled at 90°, with only the edge of the coil resting on the scalp..\n\nFor the tACS sham condition, the electric current will not be applied, but there will be a 2 s 1 mA ramp up and 2 s 1 mA ramp down, to give the participant real stimulation feelings.",[21],[40],{"name":41,"affiliation":42,"role":43},"Giacomo Koch, Prof.","IRCCS Santa Lucia Foundation","PRINCIPAL_INVESTIGATOR",[45],{"name":46,"role":47,"phone":48,"phoneExt":32,"email":49},"Giacomo Koch, Prof","CONTACT","+390651501181","g.koch@hsantlucia.it",[51,71],{"facility":42,"status":52,"city":53,"state":54,"zip":55,"country":54,"countryCode":56,"cosmosGeoPoint":57,"geoPoint":62,"contacts":63},"RECRUITING","Rome","Italy","00179","IT",{"type":58,"coordinates":59},"Point",[60,61],12.51133,41.89193,{"lat":61,"lon":60},[64,66,69],{"name":46,"role":47,"phone":48,"phoneExt":32,"email":65},"g.koch@hsantalucia.it",{"name":67,"role":68,"phone":32,"phoneExt":32,"email":32},"Sonia Bonnì, PhD","SUB_INVESTIGATOR",{"name":70,"role":68,"phone":32,"phoneExt":32,"email":32},"Francesco Di Lorenzo",{"facility":72,"status":73,"city":74,"state":75,"zip":76,"country":54,"countryCode":56,"cosmosGeoPoint":77,"geoPoint":81,"contacts":82},"I.R.C.C.S. Centro Neurolesi Bonino Pulejo","NOT_YET_RECRUITING","Messina","Sicily","98124",{"type":58,"coordinates":78},[79,80],15.55256,38.19394,{"lat":80,"lon":79},[83],{"name":84,"role":47,"phone":32,"phoneExt":32,"email":85},"Rosaria De Luca, PhD","rosaria.deluca@irccsme.it",{"type":87,"investigatorFullName":32,"investigatorTitle":32,"investigatorAffiliation":32,"oldNameTitle":32,"oldOrganization":32},"SPONSOR",[89],{"name":90,"class":6},"IRCCS Centro Neurolesi Bonino Pulejo","100598767",false,"NCT07075770","Novel Personalized Non Invasive Combined Magnetic and Electrical Stimulation of the DMN in Mild AD Patients","Novel Personalized Non Invasive Combined Magnetic and Electrical Stimulation of the Default Mode Network in Mild AD Patients (CMES-AD)","CMES_AD","Inclusion Criteria:\n\n* Patients with a diagnosis of AD according to IWG criteria\n* 20 \\> MMSE \\\u003C 28\n* Patients with CSF specific biomarker profile or with a positive Amyloid Pet Scan consistent with the presence of amyloid pathology\n* Global Clinical Dementia Rating (CDR) ≤1\n* Previous decline in cognition for more than six months as documented in patient medical records\n* A caregiver available and living in the same household or interacting with the patient and available\n* Patients living at home or nursing home setting without continuous nursing care\n* General health status acceptable for a participation in a 6-month clinical trial\n* Stable pharmacological treatment for at least one month prior to screening\n* No regular intake of prohibited medications.\n* Signed informed consent by the patient. If there are any doubts that the patient is mentally capable of giving informed consent, the patient will be examined and verified to be mentally capable by an independent physician\u002F neurologist, prior to the initiation of any study specific procedure. Signed consent of the caregiver\n\nExclusion Criteria:\n\n* Failure to undergo screening or baseline exams\n* Hospitalization or change in chronic concomitant medications one month before the screening or during the screening period\n* Clinical, laboratory, or neuroimaging results consistent with:\n\n  1. other primary degenerative dementia (Lewy body dementia, frontotemporal dementia, Huntington's disease, Creutzfeldt-Jakob disease, Down syndrome, etc.);\n  2. other neurodegenerative conditions (Parkinson's disease, amyotrophic lateral sclerosis, etc.);\n  3. orthostatic hypotension and autonomic disorders\n  4. cerebrovascular disease (major infarction, a strategic infarction or multiple lacunar infarctions, extensive white matter lesions \\> one quarter of total white matter);\n  5. other central nervous system diseases (severe traumatic brain injury, tumors, subdural hematoma, or other space-occupying processes, etc.);\n  6. seizure disorder.\n  7. Other infectious, metabolic, or systemic diseases affecting the central nervous system (syphilis, existing hypothyroidism, current vitamin B12 or folate deficiency, serum electrolytes outside normal limits, juvenile diabetes, etc.).\n* A current DSM-V diagnosis of major depression, schizophrenia, or bipolar disorder.\n* Clinically significant, advanced, or unstable disease that may interfere with primary or secondary variable assessments and may affect the assessment of the patient's clinical or mental state, or expose the patient to special risk, such as:\n\n  1. Disability that may prevent the patient from completing all study requirements (e.g., blindness, deafness, severe language difficulties, etc.);\n  2. Opioid-containing analgesics\n  3. Suspected or known drug or alcohol abuse, i.e., more than about 60 g of alcohol (about 1 liter of beer or 500 ml of wine) per day, indicated by a high mean corpuscular volume (MCV) above the normal value at screening;\n  4. Any condition that, in the investigator's judgment, makes the patient unsuitable for inclusion","ALL","50 Years","85 Years",{"count":102,"type":103},60,"ESTIMATED","INTERVENTIONAL",[106],"NA","Alzheimer's disease (AD) is increasingly recognized as a disorder marked by early synaptic dysfunction and disrupted brain network connectivity, beyond the traditional focus on amyloid pathology. Synaptic plasticity (crucial for learning and memory) is compromised in AD and represents a promising therapeutic target. In particular, alterations in the Default Mode Network (DMN), especially in regions like the precuneus, suggest that restoring connectivity and enhancing plasticity may improve cognitive outcomes. This project proposes a novel, precision-delivered non-invasive brain stimulation protocol that combines repetitive transcranial magnetic stimulation (rTMS) and transcranial alternating current stimulation (tACS) over the DMN. The intervention will be evaluated through cognitive testing, blood-based biomarkers, MRI and TMS-EEG, alongside immersive virtual environments to assess sensorimotor and cognitive function. This approach aims to test neuromodulation strategies capable of slowing neurodegeneration and supporting early detection and rehabilitation in AD.",[109],"Alzheimer Disease",[111,112,113,114,115,116],"Non Invasive Brain Stimulation","Transcranial Magnetic Stimulation","Intermittent Theta Burst Stimulation","Transcranial Electrical Stimulation","Transcranial Alternating Current Stimulation","Default Mode Network","2026-01-09",{"date":119,"type":120},"2026-01-13","ACTUAL",{"date":122,"type":120},"2025-01-01",{"date":124,"type":103},"2027-08-31",{"name":5,"class":6},2]