[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100562036":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":37,"centralContacts":41,"locations":49,"responsibleParty":70,"collaborators":36,"id":73,"slug":74,"hasResults":75,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":79,"eligibilityCriteria":80,"healthyVolunteers":75,"sex":81,"minAge":82,"maxAge":83,"enrollmentInfo":84,"targetDuration":36,"studyType":87,"phases":88,"briefSummary":91,"conditions":92,"keywords":100,"overallStatus":52,"whyStopped":36,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":114},{"fullName":5,"class":6},"University of California, Los Angeles","OTHER",[8,14,18],{"label":9,"type":10,"description":11,"interventionNames":12},"Open-Label Active deep rTMS","EXPERIMENTAL","The first stage of the study will consist of protocol refinement. In this first stage of 5-10 participants, all participants will receive open-label active treatment.\n\nTreatment will consist of 16 sessions of deep rTMS spread over 5 weeks. The induction phase of treatment will be 4 sessions per day for 3 consecutive days (with 60 minutes between sessions), followed by 1 session per week for 4 weeks.\n\nIndividual sessions will consist of 1600 pulses of 20Hz rTMS delivered in 40 pulse trains to the precuneus (using MRI structural neuronavigation) at 100% of depth-corrected motor-threshold with a 28 second intertrain interval (roughly 20 minutes per session).",[13],"Device: TMS",{"label":15,"type":10,"description":16,"interventionNames":17},"Randomized Active deep precuneus rTMS","The second stage of the study will consist of both active and sham treatment groups. Treatment will consist of 16 sessions of deep rTMS spread over 5 weeks. The induction phase of treatment will be 4 sessions per day for 3 consecutive days (with 60 minutes between sessions), followed by 1 session per week for 4 weeks. Individual sessions will consist of 1600 pulses of 20Hz rTMS delivered in 40 pulse trains to the precuneus (using MRI structural neuronavigation) at 100% of depth-corrected motor-threshold with a 28 second intertrain interval (roughly 20 minutes per session). The active group will receive this protocol using an active treatment coil delivering real rTMS.",[13],{"label":19,"type":20,"description":21,"interventionNames":22},"Randomized Sham deep precuneus rTMS","SHAM_COMPARATOR","The second stage of the study will consist of both active and sham treatment groups. Treatment will consist of 16 sessions of deep rTMS spread over 5 weeks. The induction phase of treatment will be 4 sessions per day for 3 consecutive days (with 60 minutes between sessions), followed by 1 session per week for 4 weeks. Individual sessions will consist of 1600 pulses of 20Hz rTMS delivered in 40 pulse trains to the precuneus (using MRI structural neuronavigation) at 100% of depth-corrected motor-threshold with a 28 second intertrain interval (roughly 20 minutes per session). The placebo group will receive this protocol using a sham TMS coil delivering inactive rTMS.\n\nParticipants in the sham\u002Fplacebo group will be offered a full open-label extension treatment course of active rTMS on completion of the randomized phase.",[13,23],"Device: Transcranial Magnetic Stimulation Sham",[25,32],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"DEVICE","TMS","rTMS Stimulation Parameters Pulse count: 1600 pulses Frequency: 20Hz Pules per train: 40 pulses Inter-train interval: 28 seconds Intensity: 100% Motor Threshold (depth-corrected from MRI) Target: Precuneus using structural MRI navigation with MNI coordinates",[9,15,19],[31],"precuneus deep repetitive transcranial magnetic stimulation",{"type":26,"name":33,"description":34,"armGroupLabels":35,"otherNames":36},"Transcranial Magnetic Stimulation Sham","Sham coil placed in same location and set with same parameters as active treatment coil. However, this device will not output active treatment and scalp electrodes will mimic the sensation of rTMS for the participant.",[19],null,[38],{"name":39,"affiliation":5,"role":40},"Michael Leuchter, MD","PRINCIPAL_INVESTIGATOR",[42,47],{"name":43,"role":44,"phone":45,"phoneExt":36,"email":46},"Cole Mathews","CONTACT","(310) 825-7797","TMSResearch@mednet.ucla.edu",{"name":39,"role":44,"phone":48,"phoneExt":36,"email":46},"(310) 794-2312",[50],{"facility":51,"status":52,"city":53,"state":54,"zip":55,"country":56,"countryCode":57,"cosmosGeoPoint":58,"geoPoint":63,"contacts":64},"UCLA TMS Clinical and Research Service","RECRUITING","Los Angeles","California","90095","United States","US",{"type":59,"coordinates":60},"Point",[61,62],-118.24368,34.05223,{"lat":62,"lon":61},[65,67,69],{"name":66,"role":44,"phone":45,"phoneExt":36,"email":46},"Cole Matthews, BA",{"name":68,"role":44,"phone":45,"phoneExt":36,"email":46},"Doan Ngo, BS",{"name":39,"role":40,"phone":36,"phoneExt":36,"email":36},{"type":40,"investigatorFullName":71,"investigatorTitle":72,"investigatorAffiliation":5,"oldNameTitle":36,"oldOrganization":36},"Michael K Leuchter","Fellow Physician","100562036","phase-1-deep-repetitive-transcranial-magnetic-stimulation-rtms-of-the-precuneus-for-alzheimer-disease-ad-100562036",false,"NCT06597942","Deep Repetitive Transcranial Magnetic Stimulation (rTMS) of the Precuneus for Alzheimer Disease (AD)","Protocol for Maintaining and Improving Mental Status in Alzheimer's Disease (PROMIS-AD): a Pilot Study of Repetitive Transcranial Magnetic Stimulation of the Precuneus for Alzheimer&Amp;Amp;#39;s Disease","PROMIS-AD","Inclusion Criteria:\n\n* Age 60-100 at the start of the study\n* Established diagnosis of Alzheimer's Clinical Syndrome (which is also met through a diagnosis of Alzheimer's Dementia)\n* Agreement to participate in study and able to complete informed consent process\n* Have a caregiver\u002Fstudy partner who can accompany them to all study visits\n* Have a known alternate surrogate decision-maker (in case needed) who can accompany them to the informed consent visit (this person may be the study partner mentioned above)\n* Screening MMSE score of 18-26\n* Screening GDS score \\<6\n* Either 1) treated with memory-enhancing medication (cholinesterase inhibitor) for at least 2 months, 2) failed trial with no plan to re-trial, or 3) no trial planned during the course of the study for other reasons\n* No change in use of psychotropic medication for the treatment of depression, anxiety, ADHD, or psychosis for 2 weeks prior to the study\n\nExclusion Criteria:\n\n* Participant and\u002For their surrogate are unwilling or unable to provide informed consent\n* Currently pregnant or potentially pregnant\n* Diagnosis of a dementia or cognitive disorder due to a cause other than Alzheimer's Disease\n* Diagnosis of severe Dementia (CDR \\> 2.0) at the start of the study\n* History of substance use disorder currently not in sustained remission\n* Substance misuse within the past 6 months (excluding nicotine or caffeine)\n* History of stroke, traumatic brain injury with loss of consciousness, or other major neurologic disorder (e.g., epilepsy, Huntington's disease, Parkinson's disease)\n* History of seizure disorder or family history of seizure disorder in a first-degree relative\n* Poorly-controlled hypertension, cardiovascular disease, or cerebrovascular disease\n* History of any other major active medical, neurologic, or psychiatric illness affecting cognition (associated with cognitive impairment) or a participant's ability to safely and meaningfully participate in the study\n* Non-fluent in English (not native or functionally-native)\n* Contraindication to TMS or MRI including claustrophobia, MRI-incompatible or unknown metal in body (including facial tattoos with uknown or metallic inks), surgery within 60 days, certain implants (excluding dental fillings), or previous abnormal MRI results.\n* Has previous history of TMS treatment in the past (not TMS naïve)\n* Currently enrolled in a memory-enhancement study\n* Alteration in cognitive-enhancement medication dose within the past 2 months or active plans for dose alteration during the course of the study (previously unplanned changes that occur during the study will be examined on a case-by-case basis)\n* History of treatment with lecanemab, aducanumab, donanemab, or other monoclonal antibody treatment for Alzheimer's Disease (due to lack of knowledge surrounding the impacts of these treatments)\n* Currently or within the past 2 weeks taking any of the following classes of medication:\n\n  * Anticholinergic (e.g., tolterodine, benztropine)\n  * Sedating antihistamines (e.g., diphenhydramine)\n  * any drug that has significant anticholinergic or antihistaminic side effects (e.g., tricyclic antidepressant medications, mirtazapine).\n  * Benzodiazepines. While not a strict rule out, this will be decided on a case-by-case basis\n  * Antiepileptic agents. While not a strict rule out, this will be decided on a case-by-case basis\n  * Antipsychotic agents. While not a strict rule out, this will be decided on a case-by-case basis","ALL","60 Years","100 Years",{"count":85,"type":86},54,"ESTIMATED","INTERVENTIONAL",[89,90],"PHASE1","PHASE2","The goal of this clinical trial is to learn if using deep repetitive transcranial magnetic stimulation (rTMS) targeting the precuneus is feasible, tolerable, and potentially efficacious for memory in Probable Alzheimer's Dementia. Previous work studying rTMS in Alzheimer's is mixed, but recent work studying rTMS of the precuneus is encouraging for both its short-term and long-term effects. The main questions this study aims to answer are:\n\n* Is deep rTMS of the precuneus feasible and tolerable in Alzheimer's?\n* Are there signs of positive brain changes in response to deep rTMS?\n* Is deep rTMS potentially efficacious for memory in Alzheimer's? Researchers will compare active stimulation to placebo stimulation while obtaining memory testing and measurements of the brain (imaging, scalp electrode measurements, bloodwork) to see if active treatment works to treat mild-to-moderate probable Alzheimer's Dementia.\n\nParticipants will:\n\n* Engage with memory testing, brain scans, and bloodwork during a comprehensive assessment\n* Visit the clinic 3 times for 12 consolidated rTMS sessions, followed by 4 once weekly maintenance sessions\n* Be offered a full open-label active treatment course after completing their treatment course if they are initially in the placebo group",[93,94,95,96,97,98,99],"Alzheimer&Amp;Amp;#39;s Disease","Alzheimer Disease","Dementia Alzheimer Type","Mild Alzheimer&Amp;Amp;#39;s Disease","Moderate Alzheimer&Amp;Amp;#39;s Disease","Alzheimer&Amp;#39;s Disease (AD)","Alzheimer&Amp;#39;s Dementia",[101,102,103,104],"Clinical Trial","deep repetitive transcranial magnetic stimulation (deep rTMS)","precuneus","Mild-to-Moderate Probable Alzheimer's Dementia","2026-01-19",{"date":107,"type":108},"2026-01-21","ACTUAL",{"date":110,"type":108},"2024-10-17",{"date":112,"type":86},"2026-10",{"name":5,"class":6},1]