[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"lewy-body-dementia\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:lewy-body-dementia":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,9,0,[8,65,98,126,151,170,193,219,242],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":40,"overallStatus":52,"whyStopped":4,"lastUpdateSubmitDate":53,"lastUpdatePostDateStruct":54,"startDateStruct":57,"completionDateStruct":59,"leadSponsor":61,"locationsCount":64},"100303705","retinal-imaging-in-neurodegenerative-disease-100303705",false,"NCT03233646","Retinal Imaging in Neurodegenerative Disease","Evaluating the Retinal and Choroidal Microvasculature and Structure Using Multimodal Retinal and Choroidal Imaging in Neurodegenerative Disease: iMIND Research Study","Inclusion Criteria:\n\n* Adults with neurodegenerative disease ((MCI, PD, AD, FTD, DLB, ALS, MS, HD, TBI, concussion, PTSD and other neurodegenerations as well as Down Syndrome)\n* Adults without neurodegenerative disease\n\nExclusion Criteria:\n\n* Inability to cooperate with or complete testing or other neurologic or age- related ocular conditions that would impact image acquisition.\n* Eyes that have had intraocular surgery, other than cataract surgery.\n\nIf two eyes satisfy the inclusion criteria, both eyes will be included in the study. If one eye satisfies the inclusion criteria, the eye that qualifies will be included in the study.",true,"ALL","18 Years",{"count":20,"type":21},2000,"ESTIMATED","OBSERVATIONAL","This study aims to develop and evaluate biomarkers using non-invasive optical coherence tomography (OCT) and OCT angiography (OCTA) as well as ultra-widefield (UWF) fundus photography to assess the structure and function of the retinal and choroidal microvasculature and structure in persons with mild cognitive impairment (MCI) and Alzheimer's Disease (AD), Parkinson's Disease (PD), or other neurodegenerative disease, diseases as outlined.",[25,26,27,28,29,30,31,32,33,34,35,36,37,38,39],"Alzheimer's Disease","Mild Cognitive Impairment","Parkinson's Disease","Multiple Sclerosis","Huntington Disease","Lewy Body Dementia","Frontotemporal Dementia","Amyotrophic Lateral Sclerosis (ALS)","APOE-4 Positive","Traumatic Brain Injury","Concussion","Post-Traumatic Stress Disorder","Down Syndrome","Neuro-Degenerative Disease","Normal Cognition",[41,42,43,44,45,46,47,48,49,50,51],"OCT angiography (OCTA)","Optical Coherence Tomography (OCT)","Vessel Density","Superficial Capillary Plexus","Retinal microvasculature","Scanning Laser Ophthalmoscopy","Ultra-widefield (UWF) Imaging","Perfusion Density","Retinal Nerve Fiber Layer","Ganglion Cell Inner Plexiform Layer","Choroidal Vascularity Index","RECRUITING","2026-02-02",{"date":55,"type":56},"2026-02-04","ACTUAL",{"date":58,"type":56},"2017-07-20",{"date":60,"type":21},"2026-12-31",{"name":62,"class":63},"Duke University","OTHER",1,{"id":66,"slug":67,"hasResults":11,"nctId":68,"briefTitle":69,"officialTitle":69,"acronym":70,"eligibilityCriteria":71,"healthyVolunteers":11,"sex":17,"minAge":72,"maxAge":4,"enrollmentInfo":73,"targetDuration":4,"studyType":75,"phases":76,"briefSummary":78,"conditions":79,"keywords":84,"overallStatus":52,"whyStopped":4,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":64},"100576488","tdcs-effect-on-psychotic-symptoms-in-dementia-with-lewy-bodies-dlb-and-impacts-on-caregiver-burden-100576488","NCT06785948","tDCS Effect on Psychotic Symptoms in Dementia With Lewy Bodies (DLB), and Impacts on Caregiver Burden","MCL-tDCS","Inclusion Criteria:\n\n* Male or Female, aged over 60,\n* Diagnosed with a neurodegenerative pathology of the DLB type, at a moderate stage, according to the McKeith and al. (2017) criteria\n* No change in antiparkinsonian or psychotropic medications, or cholinesterase inhibitors, for a period of one month prior to inclusion,\n* Mini Mental State Examination (MMSE) \\> 15,\n* Composite score called \"psychotic factor\" (corresponding to the sum of the psychotic-type symptoms sub-scores from the NPI \\[12\\]) greater than 0,\n* Presence of a family caregiver,\n* Sufficient written and oral expression in French,\n* Written informed consent signed by the patient and his\u002Fher family caregiver\n\nExclusion Criteria:\n\n* History of alcoholism, drug addiction or neurological diseases such as brain trauma, epilepsy, encephalitis, intracranial normal-pressure hydrocephalus, etc. which may lead to cognitive impairment,\n* Concomitant major psychiatric illness,\n* Significant physical illness or comorbidities\n* History of moderate to severe visual impairment secondary to glaucoma, cataract or macular degeneration,\n* Patient under guardianship or curators","60 Years",{"count":74,"type":21},30,"INTERVENTIONAL",[77],"NA","The goal of this pilot prospective study is to evaluate the effect of tDCS on psychotic-like symptoms in patients with Lewy Body Dementia (LBD). The main questions it aims to answer are:\n\n* What is the effect of tDCS on neuropsychiatric symptoms, especially psychotic-like symptoms?\n* What is the impact of tDCS on caregiver burden?\n\nResearchers will compare active tDCS (2mA stimulation, anode on the left dorsolateral prefrontal cortex, cathode on the right fronto-orbital) to Sham tDCS (placebo stimulation, no intensity applied) to see if there is an effect on reducing psychotic-like symptoms and on caregiver burden.\n\nParticipants will:\n\n* Undergo a stimulation phase consisting of 10 tDCS sessions of 20 minutes each, spread over 2 consecutive weeks (5 days with stimulation, 2 days without stimulation, 5 days with stimulation).\n* perform assessments at T0 (inclusion), T1 (at the end of the stimulation phase), and T2 (follow-up at 8 weeks post stimulation).",[30,80,81,82,83],"Lewy Body Dementia With Behavioral Disturbance","Burden, Caregiver","Lewy Body Disease","Dementia With Lewy Bodies",[85,86,87,88],"Transcranial Direct-Current Stimulation (t-DCS)","Brain stimulation","Psychotic symptoms","Caregiver burden","2025-09-30",{"date":91,"type":56},"2025-10-01",{"date":93,"type":56},"2025-01-10",{"date":95,"type":21},"2026-11",{"name":97,"class":63},"Association de Recherche Bibliographique pour les Neurosciences",{"id":99,"slug":100,"hasResults":11,"nctId":101,"briefTitle":102,"officialTitle":103,"acronym":4,"eligibilityCriteria":104,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":105,"enrollmentInfo":106,"targetDuration":4,"studyType":75,"phases":108,"briefSummary":110,"conditions":111,"keywords":4,"overallStatus":117,"whyStopped":4,"lastUpdateSubmitDate":118,"lastUpdatePostDateStruct":119,"startDateStruct":121,"completionDateStruct":122,"leadSponsor":124,"locationsCount":64},"100562802","phase-1-huc-msc-sev-001-nasal-drops-for-neurodegenerative-diseases-100562802","NCT06607900","hUC-MSC-sEV-001 Nasal Drops for Neurodegenerative Diseases","A Multi-center, Open, Single-arm, Basket-design Clinical Trial to Evaluate the Safety and Efficacy of Human Umbilical Cord Mesenchymal Stem Cell-derived Small Extracellular Vesicles hUC-MSC-sEV-001 Nasal Drops for the Treatment of Multiple Neurodegenerative Diseases","General Criteria:\n\nInclusion Criteria:\n\n1. Age 18-80 years (inclusive), any gender.\n2. Subjects or their legal guardians voluntarily sign a written informed consent form and are able to comply with the study requirements for dosing and follow-up.\n\nExclusion Criteria:\n\n1. Subjects who have received allogeneic mesenchymal progenitor cell therapy or its derived small extracellular vesicles.\n2. Subjects with abnormal nasal anatomy, nasal damage, severe rhinitis, or other nasal conditions that may affect the administration of the investigational product.\n3. Subjects requiring nasogastric tube insertion.\n4. Suffering from other uncontrolled diseases that may interfere with the study results, including but not limited to severe local infection, systemic infection, or immunodeficiency.\n5. Combined with malignant tumors, hematological malignancies, or other serious systemic diseases.\n6. Clinically significant history of allergic reactions, especially drug allergic reactions.\n7. Severe renal insufficiency: creatinine clearance (CrCl) \\\u003C 30 mL\u002Fmin (calculated by Cockcroft-Gault formula), or other known severe renal diseases.\n8. Peripheral blood hemoglobin (HGB) \\\u003C 100 g\u002FL, absolute neutrophil count (NEUT) \\\u003C 1.5 × 10⁹\u002FL, platelet count (PLT) \\\u003C 100 × 10⁹\u002FL, white blood cell count (WBC) \\\u003C 4.0 × 10⁹\u002FL or ≥ 12 × 10⁹\u002FL, serum albumin \\\u003C 30 g\u002FL; alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≥ 3 × upper limit of normal (ULN).\n9. HBsAg positive, or HBcAb positive with HBV DNA positive, hepatitis C virus (HCV) antibody positive, peripheral blood HCV RNA positive, HIV antibody positive; CMV DNA positive, syphilis serology positive.\n10. Contraindications to MRI examination (e.g., metal implants) or inability to tolerate MRI (e.g., claustrophobia).\n11. Women of childbearing potential not intending to use effective contraception during the trial or within 90 days after the last dose and with a positive pregnancy test record; pregnant or lactating women; men who are sexually active during the trial or within 90 days after the last dose and not intending to use effective contraception; or men planning to donate sperm during the trial or within 90 days after the last dose.\n12. Vaccination within 1 month prior to the first dose or planned during the period from enrollment until the end of follow-up.\n13. Participation in other clinical drug studies within the past 30 days.\n14. Any condition that, in the investigator's judgment, may compromise the subject's ability to understand and\u002For comply with the study procedures and\u002For follow-up.\n\nAlzheimer's Disease (AD) Specific Criteria:\n\nInclusion Criteria:\n\n1. Probable AD as defined by the 2011 National Institute on Aging-Alzheimer's Association (NIA-AA) criteria.\n2. Clinical Dementia Rating (CDR) score ≤ 1.0.\n3. Subjects have an identified, reliable caregiver.\n4. Stable treatment regimen for at least 1 month prior to dosing.\n\nExclusion Criteria:\n\n1. Major history of significant brain injury with persistent neurological impairment (with or without) or known structural brain abnormalities.\n2. Cognitive impairment due to other causes: central nervous system infection, Creutzfeldt-Jakob disease, traumatic dementia, other physical\u002Fchemical factors (e.g., drug intoxication, alcoholism, carbon monoxide poisoning), major systemic illnesses (e.g., hepatic encephalopathy, pulmonary encephalopathy), intracranial space-occupying lesions (e.g., subdural hematoma, brain tumor), endocrine disorders (e.g., thyroid disease, parathyroid disease), vitamin B12 or folate deficiency, or any other known causes.\n\nParkinson's Disease (PD) Specific Criteria:\n\nInclusion Criteria:\n\n1. Diagnosis of PD according to the 2015 Movement Disorder Society (MDS) clinical diagnostic criteria for PD.\n2. Hoehn and Yahr stage ≤ 3.\n3. Stable treatment regimen for at least 1 month prior to dosing.\n\nExclusion Criteria:\n\n1\\. Parkinsonism other than PD, including but not limited to progressive supranuclear palsy (PSP), multiple system atrophy (MSA), vascular parkinsonism, drug-induced parkinsonism, essential tremor, primary dystonia.\n\nMultiple System Atrophy (MSA) Specific Criteria:\n\nInclusion Criteria:\n\n1. Diagnosis of possible or probable multiple system atrophy.\n2. Time since diagnosis \\\u003C 3 years from baseline, with an expected survival of at least 3 years.\n3. Stable treatment regimen for at least 1 month prior to dosing.\n\nExclusion Criteria:\n\n1. Modified Unified Multiple System Atrophy Rating Scale (UMSARS) Part I score ≥ 14.\n2. Presence of any condition that, in the investigators' judgment, affects the diagnosis or assessment of MSA.\n\nDementia with Lewy Bodies (DLB) Specific Criteria:\n\nInclusion Criteria:\n\n1. Meets the revised consensus criteria for DLB (Fourth Consensus Report of the DLB Consortium, 2017).\n2. Severity of motor symptoms must be ≤ stage 3 on the Hoehn and Yahr scale.\n3. Clinical Dementia Rating (CDR) score ≤ 1.0.\n4. Stable treatment regimen for at least 1 month prior to dosing.\n\nExclusion Criteria:\n\n1. Patients currently diagnosed with any primary psychiatric disorder (e.g., schizophrenia, bipolar disorder, or major depressive episode) according to DSM-V.\n2. Patients with clinically significant or unstable systemic illness and exposure to toxicants within the past 5 years.\n\nFrontotemporal Dementia (FTD) Specific Criteria:\n\nInclusion Criteria:\n\n1. Meets the 2017 International Research Society (IRS) diagnostic criteria for FTD.\n2. Clinical Dementia Rating (CDR) score ≤ 1.0.\n3. Stable treatment regimen for at least 1 month prior to dosing.\n\nExclusion Criteria:\n\n1\\. Diagnosis of severe central nervous system diseases other than FTD that may be the cause of the patient's FTD symptoms or may affect the study objectives.\n\nAmyotrophic Lateral Sclerosis (ALS) Specific Criteria:\n\nInclusion Criteria:\n\n1. Diagnosis of Amyotrophic Lateral Sclerosis (ALS) meeting the diagnostic criteria (Revised El Escorial Criteria, 2000 or Airlie House Criteria) at the level of definite, probable, or laboratory-supported probable ALS.\n2. Disease duration ≥ 6 months and ≤ 2 years (from the first occurrence of any ALS symptom).\n3. Revised Amyotrophic Lateral Sclerosis Functional Rating Scale (ALSFRS-R) score: each individual item score ≥ 2 points (with the three respiratory items - Dyspnea, Orthopnea, and Respiratory Insufficiency - all scoring 4 points).\n4. Stable treatment regimen for at least 1 month prior to dosing.\n\nExclusion Criteria:\n\n1\\. Diagnosis of non-ALS patients based on clinical presentation and available auxiliary clinical examinations (neurophysiology, MRI or other imaging techniques, laboratory tests, etc.).","80 Years",{"count":107,"type":21},120,[109],"PHASE1","To evaluate the safety and preliminary efficacy of human umbilical cord mesenchymal stem cell-derived small extracellular vesicles hUC-MSC-sEV-001 nasal drops in multiple neurodegenerative diseases, including Alzheimer's disease, Parkinson's disease, multiple system atrophy, Lewy body dementia, frontotemporal dementia, and amyotrophic lateral sclerosis.",[112,113,30,114,115,116],"Alzheimer Disease","Parkinson Disease","Multiple System Atrophy","Fronto-temporal Dementia","Amyotrophic Lateral Sclerosis","NOT_YET_RECRUITING","2025-07-01",{"date":120,"type":56},"2025-07-08",{"date":118,"type":21},{"date":123,"type":21},"2028-08-31",{"name":125,"class":63},"Xuanwu Hospital, Beijing",{"id":127,"slug":128,"hasResults":11,"nctId":129,"briefTitle":130,"officialTitle":131,"acronym":4,"eligibilityCriteria":132,"healthyVolunteers":11,"sex":17,"minAge":133,"maxAge":134,"enrollmentInfo":135,"targetDuration":4,"studyType":75,"phases":137,"briefSummary":138,"conditions":139,"keywords":4,"overallStatus":52,"whyStopped":4,"lastUpdateSubmitDate":141,"lastUpdatePostDateStruct":142,"startDateStruct":144,"completionDateStruct":146,"leadSponsor":148,"locationsCount":64},"100582380","pulsed-electromagnetic-field-treatment-with-dementia-patients-100582380","NCT06862557","Pulsed Electromagnetic Field Treatment With Dementia Patients","Effects of PEMF Treatment on Patients With Mild to Moderate Dementia in a Controlled Pilot Study","Inclusion Criteria:\n\n1\\. Age ≥ 50 years 2.2. Patients diagnosed with mild to moderate AD\u002FADRD including Alzheimer's disease, Lewy body dementia, and Vascular dementia - defined as a global CDR of 0.5 or 1 at baseline.\n\n3\\. At least an eighth grade of educational achievement 4. If female, post-menopausal. 5. MMSE score between 16 and 26 (inclusive) 6. Capable of providing consent or having a surrogate (e.g., spouse, family member) capable of providing consent if participant lacks consent capacity 7. Able and willing to comply with the protocol 8. If the participant is receiving a cholinesterase inhibitor and\u002For memantine, such medication has been prescribed for at least 3 months prior to screening and the dose is stable for at least 60 days prior to screening (that dose needs to be maintained throughout the period of this study) 10. Physical clearance for study participation as evaluated by the clinician\n\nExclusion Criteria:\n\n1. The patient lacks capacity to consent to study participation and no surrogate is available to provide consent\n2. The patient does not have a study partner who would be available for interview\n3. History of epileptic seizures or epilepsy\n4. Has Frontotemporal Dementia\n5. Currently taking medication that lowers the seizure threshold, excluding blood thinners\n6. Is currently taking anti-amyloid monoclonal antibodies (past treatment is allowed if termination of treatment occurred at least 3 months prior to the baseline visit).\n7. Presence of depression, bipolar disorder, a psychotic disorder, or any other neurological or psychiatric condition (whether now or in the past), which the Investigator finds as interfering with the study\n8. Severe agitation that would interfere with study procedures\n9. Alcoholism or substance use disorder as defined by Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) within last 5 years (addicted more than one year and or in remission less than 3 years) or severe sleep deprivation\n10. Major surgery (defined as any major abdominal, vascular or thoracic surgery requiring general anesthesia and resulting in a period of \\>1 week hospitalization) within 4 weeks\n11. Head anatomy that interferes with the fit of the treatment device\n12. Participation in another clinical trial within the previous 30 days\n13. Metal implants in the head, (i.e., cochlear implants, implanted brain stimulators and neurostimulators, aneurysm clips) with the exception of metal implants in mouth\n14. Criteria to exclude participants from the blood draw study:\n\nAny condition that may significantly increase risks associated with blood draws","50 Years","100 Years",{"count":136,"type":21},48,[77],"An open label pilot study in mild to moderate AD\u002FADRD patients to assess the effects of treatment with ECHS AD\u002FADRD pulsed electromagnetic treatment device on disease progression. Enrolled patients will receive active devices. They will treat themselves at home three times a day for 15 minutes over 120 days. Primary end point is the The Alzheimer's Disease Assessment Scale-Cognitive Subscale. Participants will be followed-up for 9 months post-treatment.",[25,30,140],"Vascular Dementia","2025-05-15",{"date":143,"type":56},"2025-05-18",{"date":145,"type":56},"2025-04-01",{"date":147,"type":21},"2026-09-30",{"name":149,"class":150},"Herrick Medical LLC","INDUSTRY",{"id":152,"slug":153,"hasResults":11,"nctId":154,"briefTitle":155,"officialTitle":155,"acronym":4,"eligibilityCriteria":156,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":157,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":159,"conditions":160,"keywords":4,"overallStatus":52,"whyStopped":4,"lastUpdateSubmitDate":161,"lastUpdatePostDateStruct":162,"startDateStruct":164,"completionDateStruct":166,"leadSponsor":168,"locationsCount":64},"100287291","distinguishing-between-alzheimers-disease-lewy-body-dementia-and-parkinsons-disease-100287291","NCT03019757","Distinguishing Between Alzheimer's Disease, Lewy Body Dementia, and Parkinson's Disease","Inclusion Criteria:\n\n* Subjects must meet the standard clinical criteria of the syndromes of interest\n* All subjects must have enough cognitive abilities to complete study procedures, which will be operationally defined as having a Mini Mental State Examination (MMSE) score greater or equal to 10.\n* Subjects must be on stable cognitive and psychoactive medication regimen for the preceding four weeks of enrollment.\n* Subjects must have a responsible study partner that either lives with them or is in regular contact with them at least 4 out of 7 days per week.\n* Subjects must have visual and auditory acuity adequate for testing.\n\nExclusion Criteria:\n\n* Any other condition (other than the primary diagnosis), which in the opinion of the investigators might contribute to the syndrome of dementia or complicate its assessment.\n* active medical disorder that could preclude participation in this protocol\n* Women who are pregnant or are breast feeding\n* severe renal impairment as defined by glomerular filtration rate (GFR) less than 30 (may have increased radiation exposure with the DaTscan).\n* Subjects in whom English is not the 1st language\n* Subjects with educational level less than 12 years\n* Subjects who have ever participated in an experimental study with an amyloid targeting agent unless it can be documented that the subject received only placebo during the course of the trial.",{"count":158,"type":21},76,"The study is designed to characterize the clinical, neuropsychological, polysomnographic, and neuroimaging findings among subjects with Alzheimer's disease, Lewy Body dementia, and Parkinsons' Disease.",[25,30,27],"2025-03-25",{"date":163,"type":56},"2025-03-30",{"date":165,"type":56},"2018-08-30",{"date":167,"type":21},"2026-12",{"name":169,"class":63},"Douglas Scharre",{"id":171,"slug":172,"hasResults":11,"nctId":173,"briefTitle":174,"officialTitle":175,"acronym":176,"eligibilityCriteria":177,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":178,"targetDuration":4,"studyType":75,"phases":179,"briefSummary":180,"conditions":181,"keywords":4,"overallStatus":52,"whyStopped":4,"lastUpdateSubmitDate":184,"lastUpdatePostDateStruct":185,"startDateStruct":187,"completionDateStruct":189,"leadSponsor":191,"locationsCount":64},"100564635","exergaming-revolution-in-dementia-100564635","NCT06631742","Exergaming Revolution in Dementia","The Effect of an Exergaming Intervention on Physical Activity and Sleep in People With Major Neurocognitive Disorders Living in Long-term Care Facilities: a Pilot Randomized Controlled Trial.","GameDementia","Inclusion Criteria:\n\n* Neurocognitive disorder based on Alzheimer's Disease, Parkinson's disease, Lewy body dementia or Mixed dementia according to the criteria of the American Psychiatric Association: Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM 5)\n* Mini-Mental-Status-Examination (MMSE) Score of ≥5 and ≤26 out of e maximum of 30\n\nExclusion Criteria:\n\n* MMSE \\\u003C5\n* Unstable cardiovascular condition or other medical condition that does not allow for safe participation according to the recommendations of the American College of Sports Medicine\n* Planned transfer to another facility within the next 3 months\n* Acute behavioural problems",{"count":136,"type":21},[77],"This pilot randomized controlled trial evaluates the effect of a 12 weeks exergaming training in people with major neurocognitive disorders (MNCD) living in long-term care facilities.",[182,112,113,30,183],"Major Neurocognitive Disorder","Mixed Dementias","2024-10-07",{"date":186,"type":56},"2024-10-08",{"date":188,"type":56},"2024-09-27",{"date":190,"type":21},"2027-04-30",{"name":192,"class":63},"Eastern Switzerland University of Applied Sciences",{"id":194,"slug":195,"hasResults":11,"nctId":196,"briefTitle":197,"officialTitle":198,"acronym":199,"eligibilityCriteria":200,"healthyVolunteers":11,"sex":17,"minAge":72,"maxAge":4,"enrollmentInfo":201,"targetDuration":4,"studyType":75,"phases":203,"briefSummary":205,"conditions":206,"keywords":207,"overallStatus":52,"whyStopped":4,"lastUpdateSubmitDate":210,"lastUpdatePostDateStruct":211,"startDateStruct":213,"completionDateStruct":215,"leadSponsor":217,"locationsCount":64},"100557358","phase-2-safety-and-efficacy-of-ar1005-in-patients-with-lewy-body-disease-100557358","NCT06537076","Safety and Efficacy of AR1005 in Patients with Lewy Body Disease","A Randomized, Double-blind, Phase IIa Clinical Trial to Study the Safety and Efficacy of AR1005 in Patients with Lewy Body Disease","AR1005","Inclusion Criteria:\n\n* men and women over the age of 60\n\n  * Communication in Korean is possible and the purpose and process of the study are fully understood and agreed\n\n    * Total score of 26 points or less in the simplified mental health assessment (K-MMSE)\n\n      * Dementia Clinical Evaluation Scale (CDR) Total score of 0.5 or higher\n\n        * Medical history, neurological examination, hematologic examination, Seoul neuropsychological examination 2nd edition, brain magnetic resonance imaging suspected of cognitive impairment due to dementia with Lewy bodies as the cause of cognitive decline\n\n          i. Lewy body dementia\n          1. In accordance with the guidelines for the 4th report of the Dementia with Lewy Bodies Consortium (DLBC) published in 2017, if it falls under Probable Dementia with Lewy Bodies\n          2. Required Requirements\n\n             1. Dementia, defined as cognitive decline that progresses sufficiently to impair normal social and professional functions or daily life\n             2. Defects in attention, enforcement, and space-time capabilities are noticeable in the inspection\n          3. Core clinical features\n\n             1. variation in cognitive function\n             2. vision\n             3. Parkinson's syndrome: One or more manifestations of sinusitis, stable progress, or stiffness\n             4. REM sleep behavior disorder\n          4. Indicative biomarker\n\n             1. Decreased intake of dopamine carrier PET-phase nuclear\n             2. \\[I-123\\]-MIBG myocardial scintigraphy intake decreased\n             3. REM sleep behavior disorder according to polymorphic test\n          5. In the case of two or more key aspects, or one or more key clinical features and one or more indicative biomarkers are satisfied\n\n             ii. Bulb Lewy body dementia (Prodromal DLB)\n\n          \u003C!-- -->\n\n          1. If it falls under the Probable MCI-LB with a mild cognitive impairment according to the criteria for diagnosing precursor Lewy body dementia announced in 2020\n          2. Required Requirements\n\n             a. cognitive decline observed when judged by the patient, guardian, or clinician b. Objective cognitive decline (although it is not related to any cognitive domain, it should be mainly related to the deterioration of execution function and space-time ability)\n          3. Core clinical features\n\n             1. variation in cognitive function\n             2. vision (nap, dazed, same document, angry)\n             3. Parkinson's syndrome: One or more manifestations of sinusitis, stable progress, or stiffness\n             4. REM sleep behavior disorder\n          4. Indicative biomarker\n\n             a. Decreased intake of dopamine carrier PET-phase nuclear b. \\[I-123\\]-MIBG myocardial scintigraphy intake decreased c. REM sleep behavior disorder according to polymorphic test\n          5. The leading mild cognitive impairment due to dementia with Lewy bodies has two or more key features or satisfies one or more key clinical features and one or more indicative biomarkers\n\n             ⑥ Patients with caregivers who are in regular contact with the subject (Note: caregivers may support the subject during the clinical trial \\[compliance supervision and reporting of the subject's status\\], defined as those who spend at least 8 hours per week with the subject)\n\n             ⑦ Patients who can walk or move with walking aids (i.e., walkers, canes, or wheelchairs)\n\n             ⑧ Patients with sufficient vision, hearing, language skills, motor skills, and comprehension to follow the examination procedure as judged by the tester (Aids such as glasses and hearing aids are allowed)\n\n             ⑨ an examination Patients who have voluntarily decided to participate in this clinical trial and obtained the consent of the subject in writing from both the subject and the subject's legal representative (where written consent is not available, the tester shall keep a record of the matters that the subject has verbally agreed to participate in the trial)\n\n             Exclusion Criteria:\n* In hematologic and brain magnetic resonance imaging tests conducted within 6 months, other causes of cognitive decline such as neurosyphilis, hypo\u002Fhyper-throidism, metabolic encephalopathy, brain tumor, acute cerebral hemorrhage, acute cerebral infraction, and Wernicke's encephalopathy are suspected\n\n  * Subjects who are or are suspected of having an irritable allergy to AR1005-KRP2-01\n\n    * If you are already on antistatic medication\n\n      * A person who cannot perform a brain magnetic resonance image (but if there is a brain magnetic resonance image taken within one year, the brain magnetic resonance image can be omitted)\n\n        * voluntary Employees directly involved in this clinical study or their immediate family members who find it difficult to participate\n\n          * If there is a history of psychiatric disorders: major effective disorder, schizophrenia, schizo-effective disorder\n\n            ⑦ If an electroencephalogram cannot be performed\n\n            ⑧ Patients who are already taking acetylcholinesterase inhibitor (donepezil and rivastigmine) or taking it in patch form (but can change to rivastigmine PO to participate in the study)\n\n            ⑨ Patients with moderate to severe liver disorder (Child-Pugh grade B) and dialysis due to decreased renal functiona patient with end-stage renal impairment receiving\n\n            ⑩ Patients discontinued administration due to aseptic meningitis associated with AR1005-KRP2-01\n\n            ⑪ Patients with genetic problems such as galactose intolerance, lactose-degrading enzyme deficiency, or glucose-galactose absorption disorders",{"count":202,"type":21},60,[204],"PHASE2","This study is a phase 2a, single-center, double-blind and randomized clinical trial that evaluates the safety and efficacy of AR1005 administration in 60 patients with cognitive impairment due to Lewy body disease. The study evaluates whether the administration of AR1005 in patients with cognitive impairment due to Lewy body disease has the effect of improving cognitive function, behavioral psychological symptoms, cognitive fluctuations, movement, brain waves and brain activity.",[30],[208,209],"Lewy body dementia","DLB","2024-09-30",{"date":212,"type":56},"2024-10-02",{"date":214,"type":56},"2024-01-01",{"date":216,"type":21},"2025-12",{"name":218,"class":63},"Yonsei University",{"id":220,"slug":221,"hasResults":11,"nctId":222,"briefTitle":223,"officialTitle":224,"acronym":225,"eligibilityCriteria":226,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":134,"enrollmentInfo":227,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":229,"conditions":230,"keywords":4,"overallStatus":52,"whyStopped":4,"lastUpdateSubmitDate":233,"lastUpdatePostDateStruct":234,"startDateStruct":236,"completionDateStruct":238,"leadSponsor":240,"locationsCount":64},"100542031","advances-in-telephone-based-cognitive-screening-procedures-100542031","NCT06337578","Advances in Telephone-based Cognitive Screening Procedures","Avanzamenti in Materia di Screening Cognitivo Telefonico","TBCS","Inclusion criteria:\n\nPatient cohorts: diagnosis of interest. NIs: not applicable\n\nExclusion Criteria:\n\nPatient cohorts\n\n* age \\\u003C18 years;\n* denial of informed consent to voluntary participation and data processing;\n* absence of the diagnosis of interest;\n* absence of a de visu cognitive screening assessment carried out in the 6 months prior to recruitment;\n* positive history of 1) psychiatric pathologies, 2) serious and\u002For uncompensated general-medical conditions and 3) uncorrected visual\u002Fhearing deficits.\n\nNIs:\n\n* age \\\u003C18 years;\n* denial of informed consent to voluntary participation and data processing;\n* positive history of 1) brain disorders, 2) serious and\u002For uncompensated general-medical conditions and 3) uncorrected visual\u002Fhearing deficits.",{"count":228,"type":21},280,"1. Background\n\n   Cognitive screening procedures via performance-based tests represent an essential, albeit preliminary, element within the diagnostic and interventional process as addressed to patients with chronic neurological disorders. Furthermore, in these populations, cognitive screening measures are often employed as outcomes in epidemiological settings, as well as endpoints in clinical trials. Therefore, cognitive screeners need to possess robust clinimetric and clinical usability properties - the investigation of which must be country-specific (i.e., specific to each language and culture).\n\n   The need for such clinimetric and feasibility studies is even more true if referred to telephone-based cognitive screening (TBCS) procedures - which, until recently, have been mostly neglected in Italy, despite having the potential to bring clear benefits to clinical practice and research. In fact, TBCS techniques allow, through the use of a very widespread, accessible and easy-to-use telecommunication medium, to break down the geographical, logistical, socio-demographic and organizational barriers that make it difficult and\u002For prevent 1) access to these clinical services and 2) the continuity of their provision, as well as the creation and completion of 3) large-scale epidemiological studies and 4) decentralized clinical trials. However, although some TBCS tests have recently been developed and standardized in Italy, their clinimetric properties and clinical usability in populations with chronic neurological disorders have not yet been investigated. Furthermore, currently, the \"paper-and-pencil\" version of the international gold-standard for TBCS procedures . i.e. the Telephone Interview For Cognitive Status (TICS), which has been recently standardized in this country - is not available within the Italian scenario. In fact, although the feasibility of a de visu version of the TICS (i.e., In-Person TICS; IP-TICS) has been demonstrated in this country, an actual standardization of this test has not yet been implemented to date. Such a tool would, however, allow flexible use of screening assessments, regardless of the delivery method, both in clinical and experimental contexts.\n2. Aims\n\n   The present study primarily aims to provide exhaustive evidence regarding the psychometric, diagnostic and both cross-sectional and longitudinal clinical usability of TBCS that are currently available within the Italian scenario in populations with chronic neurological disorders. Secondly, this study aims to derive, in normotypical Italian subjects, 1) normative data for the IP-TICS and 2) the conversion algorithms between the latter (and other widely used \"paper-and-pencil\" screeners ) and the TICS.\n3. Methods\n\nThe study is monocentric, observational, prospective. Over a period of 3 years, patients who have already undergone an in-person cognitive screening session within 6 months prior to recruitment and falling under the following diagnostic categories will be recruited: 1) amyotrophic lateral sclerosis (N≥88); 2) Alzheimer's disease (N≥66); 3) Lewy body dementia (N≥30); 4) frontotemporal dementia (N≥30); 5) chronic cerebrovascular disorders (N≥66). Furthermore, N≥287 normotypical subjects representative of the Italian population will be recruited. The following TBCS tests will be administered to patients: 1) TICS; 2) Telephone-based Frontal Assessment Battery; 3) Telephone Language Screener; 4) Telephone-based Verbal Fluency Battery; 5) ALS Cognitive Behavioral Screen-Phone Version. Additionally, patients will undergo a functional evaluation using caregiver-report questionnaires evaluating instrumental and non-instrumental skills of daily living and behavioral changes. Normal subjects will instead be administered: 1) TICS; 2) IP-TICS; 3) Mini-Mental State Examination (MMSE); 4) Montreal Cognitive Assessment (MoCA). In patients, telephone follow-ups are expected after 6, 12 and 18 months. Statistical analyses will be carried out aimed at 1) the detailed study, in patients, of the psychometrics, diagnostics and cross-sectional\u002Flongitudinal clinical usability of the aforementioned TBCS test, as well as at 2) the derivation, in normotypical subjects, of the normative data of the IP-TICS and MoCA Memory Index Score (MIS), as well as the conversion algorithms between TICS and IP-TICS\u002FMMSE\u002FMoCA.",[116,25,30,231,232],"Frontotemporal Degeneration","Cerebrovascular Disorders","2024-03-22",{"date":235,"type":56},"2024-03-29",{"date":237,"type":56},"2023-10-25",{"date":239,"type":21},"2026-10-25",{"name":241,"class":63},"Istituto Auxologico Italiano",{"id":243,"slug":244,"hasResults":11,"nctId":245,"briefTitle":246,"officialTitle":247,"acronym":248,"eligibilityCriteria":249,"healthyVolunteers":11,"sex":17,"minAge":133,"maxAge":250,"enrollmentInfo":251,"targetDuration":4,"studyType":75,"phases":253,"briefSummary":254,"conditions":255,"keywords":4,"overallStatus":117,"whyStopped":4,"lastUpdateSubmitDate":256,"lastUpdatePostDateStruct":257,"startDateStruct":259,"completionDateStruct":261,"leadSponsor":262,"locationsCount":64},"100477627","non-invasive-transcranial-focused-low-intensity-ultrasound-stimulation-in-patients-with-mild-lewy-body-dementia-100477627","NCT05499429","Non-invasive Transcranial Focused Low-intensity Ultrasound Stimulation in Patients With Mild Lewy Body Dementia","Clinical Single-center Randomized Controlled Trial of Non-invasive Transcranial Focused Low-intensity Ultrasound Stimulation in Patients With Mild Lewy Body Dementia","tFUS in DLB","Inclusion Criteria:\n\n* Male or female DLB patients between the ages of 50-85;\n* The psychological evaluation was in accordance with MMSE score of 18-24 (including 18 and 24) and CDR score of 0.5.\n* Can cooperate to complete clinical research.\n\nExclusion Criteria:\n\n* There is a definite history of cerebrovascular stroke, and there are definite symptoms or signs of neurological deficit at the time of onset, and there are corresponding responsible lesions left by neuroimaging。\n* Those who have a history of alcoholism, or drug addiction, or neurological diseases such as brain trauma, epilepsy, encephalitis, normal intracranial pressure hydrocephalus, etc. that can cause cognitive impairment.\n* Suffering from systemic diseases that may lead to cognitive impairment (such as liver and kidney insufficiency, endocrine diseases, vitamin deficiency).\n* Have a history of using antipsychotics for more than five years before diagnosis.\n* There are contraindications for head MRI examination.","85 Years",{"count":252,"type":21},20,[77],"A randomized controlled clinical study was conducted in the xuanwu hospital Single Center of Capital Medical University to preliminarily explore the efficacy and safety of transcranial focused low-intensity ultrasound stimulation in the treatment of dementia with Lewy bodies in the early stage, to clarify the effective mechanism and form an effective clinical treatment plan.",[30],"2022-08-10",{"date":258,"type":56},"2022-08-12",{"date":260,"type":21},"2022-09",{"date":95,"type":21},{"name":125,"class":63}]