[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"parkinson-disease-dementia\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:parkinson-disease-dementia":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,46,76,100],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":15,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":30,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100614799","phase-4-elucidating-the-role-of-cholinergic-degeneration-in-cognitive-fluctuations-in-lewy-body-dementia-100614799",false,"NCT07284290","Elucidating the Role of Cholinergic Degeneration in Cognitive Fluctuations in Lewy Body Dementia","Inclusion Criteria:\n\nArm 1:\n\n* Age range: 50 ≤ age \\\u003C 90.\n* Diagnosis of dementia with Lewy bodies (DLB), Parkinson disease dementia (PDD), Parkinson disease with Mild Cognitive Impairment (PD-MCI), Mild Cognitive Impairment with Lewy bodies (MCI-LB).\n* DLB participants must fulfill criteria for clinically probable DLB based on the 2017 4th consensus report of the DLB consortium.\n* PDD participants must meet criteria for clinically probable PD according to the MDS Clinical Diagnostic Criteria for Parkinson's Disease and must also meet criteria for probable PDD based on the 2007 Movement Disorders Society clinical diagnostic criteria.\n* PD-MCI participants must meet criteria for clinically probable PD according to the MDS Clinical Diagnostic Criteria for Parkinson's Disease and meet criteria for Mild Cognitive Impairment on cognitive testing at screening.\n* MCI-LB participants with must meet established research criteria.\n* Capacity to provide informed consent or, if unable, availability of a legally authorized representative or guardian who can provide informed consent.\n* Availability of informant (for participants meeting criteria for dementia).\n* Ability and willingness to comply with the study-related procedures.\n* Fluent in spoken and written English (due to cognitive testing)\n\nExclusion Criteria:\n\nArm 1\n\n* History of cognitive disorder or psychiatric disorder other than that related to dementia with Lewy bodies or Parkinson disease dementia.\n* History of deep brain stimulation or any neurosurgical procedure.\n* History of structural brain disease or known significant cerebrovascular disease.\n* History of seizures or epilepsy and\u002For use of sodium channel blockers, i.e. carbamazepine, oxcarbazepine, phenytoin, topiramate, lamotrigine, felbamate, zonisamide, rufinamide, lacosamide, eslicarbazepine, and valproate.\n* Greater than two alcoholic drinks per day for men and one per day for women.\n* Regular use of benzodiazepines or barbiturates. (If benzodiazepines are taken as needed only, these medications cannot be taken within 5 half-lives of screening visit or between screening visit and EEG.)\n* Severe dementia (based on PI assessment of subject dependence level for instrumental activities of daily living)\n* Any contraindication to brain MRI.\n* Any medical condition that would interfere with ability to complete all study procedures.\n* Participants must not be pregnant, planning to become pregnant, or father a child for the duration of the study\n\nInclusion Criteria:\n\nArm 2 (Cholinesterase inhibitor cohort) inclusion criteria:\n\n* Completed Aim 1.\n* Clinical diagnosis of LBD (DLB or PDD) with CF.\n* Not taking a cholinesterase inhibitor and has not taken a cholinesterase inhibitor in the previous 90 days.\n* Ability and willingness to comply with the ChEI Cohort procedures (including galantamine administration), or a caregiver willing and able to ensure compliance.\n\nExclusion Criteria:\n\nArm 2 (Cholinesterase inhibitor cohort) exclusion criteria:\n\n* Severe hepatic impairment.\n* Renal failure.\n* Significant bradycardia (\\\u003C50 bpm) at screening or history of AV block.\n* Any contraindication to galantamine administration based on PI discretion.\n\nInclusion criteria:\n\nArm 3 (Healthy Controls)\n\n* Age range: 50 ≤ age \\\u003C 90.\n* Healthy controls should not have any known neurologic conditions that could interfere with study procedures or results.\n* Capacity to provide informed consent or, if unable, availability of a legally authorized representative or guardian who can provide informed consent.\n* Availability of informant (for participants meeting criteria for dementia).\n* Ability and willingness to comply with the study-related procedures.\n* Fluent in spoken and written English (due to cognitive testing).\n\nExclusion Criteria:\n\nArm 3 (Healthy Controls)\n\n* No History of cognitive disorder or psychiatric disorder other than that related to dementia with Lewy bodies or Parkinson disease dementia.\n* No History of deep brain stimulation or any neurosurgical procedure.\n* No History of structural brain disease or known significant cerebrovascular disease.\n* No History of seizures or epilepsy and\u002For use of sodium channel blockers, i.e. carbamazepine, oxcarbazepine, phenytoin, topiramate, lamotrigine, felbamate, zonisamide, rufinamide, lacosamide, eslicarbazepine, and valproate.\n* Any medical condition that would interfere with ability to complete all study procedures.\n* Participants must not be pregnant, planning to become pregnant, or father a child for the duration of the study",true,"ALL","50 Years","89 Years",{"count":20,"type":21},120,"ESTIMATED","INTERVENTIONAL",[24],"PHASE4","The proposed study aims to address the critical gaps in understanding the mechanisms of CF (Cognitive Fluctuations) by leveraging recently emerged molecular biomarkers, advanced neuroimaging techniques to assess measures of cholinergic degeneration, and synchronous EEG and assessments of attention. One of the overarching innovations of study is combining all of these assessments into one integrated research plan",[27,28,29],"Dementia With Lewy Bodies","Parkinson Disease Dementia","Healthy Controls",[31,32],"Parkinson Disease with Mild Cognitive Impairment","Mild Cognitive Impairment with Lewy Bodies","RECRUITING","2026-03-04",{"date":36,"type":37},"2026-03-06","ACTUAL",{"date":39,"type":37},"2025-12-08",{"date":41,"type":21},"2029-11",{"name":43,"class":44},"Virginia Commonwealth University","OTHER",1,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":50,"acronym":51,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":16,"minAge":53,"maxAge":4,"enrollmentInfo":54,"targetDuration":4,"studyType":22,"phases":56,"briefSummary":59,"conditions":60,"keywords":62,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":45},"100604822","phase-1-phase-2-trial-of-tributyrin-in-people-with-parkinsons-disease-and-cognitive-impairments-100604822","NCT07154511","Phase 2 Trial of Tributyrin in People With Parkinson's Disease and Cognitive Impairments","BUTTER2","Inclusion Criteria:\n\n* Male or Female, age 45 years and over.\n* Diagnosis of PD based on the United Kingdom Parkinson's Disease Society Brain Bank Diagnostic Research Criteria (Hughes et al., 1992) AND evidence of mild cognitive impairment (Litvan et al., 2012) OR Diagnosis of PDD (Emre et al., 2007).\n* If taking cholinesterase inhibitors, benzodiazepines, memantine, or anti-psychotic medications, on a stable regimen as defined by no medication changes for these drugs in prior 4 weeks.\n\nExclusion Criteria:\n\n* Evidence of atypical parkinsonism.\n* Contra-indications to MR imaging including but not limited to pacemakers, aneurysm clips, intraocular metal, cochlear implant, or severe claustrophobia.\n* Evidence of large vessel stroke or mass lesion on MRI.\n* Regular use of typical anti-cholinergic drugs.\n* Recent history of significant, uncontrolled GI disease such as GERD, colorectal cancer.\n* Significant metabolic or uncontrolled medical comorbidity.\n* Pregnant or nursing.\n* Suicidal ideation, as indicated by a response of 2 or 3 on question 9 of the Beck Depression Inventory.\n* Any other condition or criterion that would preclude safe and meaningful participation in the study.","45 Years",{"count":55,"type":21},45,[57,58],"PHASE1","PHASE2","The goal of this clinical trial is to learn if taking a tributyrin supplement works to improve memory and thinking and walking and balance in adults with Parkinson disease Parkinson disease dementia. It will also learn about the safety of tributyrin supplementation. The main questions it aims to answer are:\n\n1. Does tributyrin improve memory\u002Fthinking test scores and walking\u002Fbalance ability?\n2. What medical problems do participants have when taking tributyrin?\n\nResearchers will compare tributyrin to a placebo (a look-alike substance that contains no drug) to see if tributyrin works to treat Parkinson disease symptoms.\n\nParticipants will:\n\n1. Take tributyrin 3 times a day for 80-100 days\n2. Complete motor and cognitive testing at the clinic before and after the supplementation period\n3. Complete brain imaging (MRI scans and PET scans) before and after the supplementation period.",[61,28],"Parkinson Disease",[63,64,65,66],"short chain fatty acid","butyrate","tributyrin","functional neuroimaging","2025-11-10",{"date":69,"type":37},"2025-11-12",{"date":71,"type":37},"2025-11-07",{"date":73,"type":21},"2027-05",{"name":75,"class":44},"Prabesh Kanel",{"id":77,"slug":78,"hasResults":11,"nctId":79,"briefTitle":80,"officialTitle":80,"acronym":4,"eligibilityCriteria":81,"healthyVolunteers":11,"sex":16,"minAge":82,"maxAge":4,"enrollmentInfo":83,"targetDuration":85,"studyType":86,"phases":4,"briefSummary":87,"conditions":88,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":45},"100439080","parkinsons-disease-and-movement-disorders-clinical-database-100439080","NCT04997642","Parkinson's Disease and Movement Disorders Clinical Database","Inclusion Criteria:\n\nAny person who receives medical care for the diagnosis of Parkinson's disease with mild cognitive impairment (MCI) or dementia may be eligible to participate in the research database. There are no limitations for database participation based on age, disease severity or presence of cognitive impairments, as long as the person is able to complete the research assessments.\n\nExclusion Criteria:\n\nAbsence of Parkinson's disease diagnosis. There are no limitations for database participation based on age, disease severity or presence of cognitive impairments, as long as the person is able to complete the research assessments.","18 Years",{"count":84,"type":21},250,"15 Years","OBSERVATIONAL","The research database contains demographic and family history information, longitudinal information on the clinical symptoms, neuropsychological profile and treatments, stored biological samples, and brain images of patients with Parkinson's disease and related disorders receiving care at the Parkinson's disease and Movement Disorders Center and the Hospital of the University of Pennsylvania.",[61,28,89,90],"Lewy Body Parkinson Disease","Lewy Body Dementia With Behavioral Disturbance","2025-10-01",{"date":93,"type":37},"2025-10-07",{"date":95,"type":37},"2019-09-30",{"date":97,"type":21},"2029-09-15",{"name":99,"class":44},"University of Pennsylvania",{"id":101,"slug":102,"hasResults":11,"nctId":103,"briefTitle":104,"officialTitle":105,"acronym":4,"eligibilityCriteria":106,"healthyVolunteers":11,"sex":16,"minAge":82,"maxAge":107,"enrollmentInfo":108,"targetDuration":4,"studyType":22,"phases":110,"briefSummary":112,"conditions":113,"keywords":4,"overallStatus":114,"whyStopped":4,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":116,"startDateStruct":118,"completionDateStruct":120,"leadSponsor":122,"locationsCount":4},"100554120","to-evaluate-the-safety-of-dbs-in-patients-with-primary-parkinsons-disease-100554120","NCT06494956","To Evaluate the Safety of DBS in Patients With Primary Parkinson's Disease","A Prospective, Single-center, Open Clinical Study to Evaluate the Safety of Implantable Rechargeable Computerized Deep Nerve Stimulation Systems in Patients With Primary Parkinson's Disease","Inclusion Criteria:1. Aged 18-70 years old, patients with primary Parkinson's disease;2. The duration of Parkinson's disease is 5 years or more;3. The stage of Hoehn-Yahr in the \"off\" (without medication) state is 2 or more stages;4. UPDRS motion score ≥30 in \"Off\" state;5. Good response to dopamine drugs, acute levodopa experiment UPDRS exercise score improvement rate of more than 30% (experimental drug Medoba 250mg);6. The daily drug shutdown period is at least 6 hours, or there are sports complications such as serious transactions, and repeated adjustments of drugs still cannot be effectively improved;7. MMSE score ≥24 points on the simple intelligent mental state Examination Scale;8. Have the ability of independent external charging operation;9. Patients or their family members can fully understand the treatment and sign informed consent;10. The patient had good compliance and was able to meet the requirements of postoperative follow-up.\n\nExclusion Criteria:1. Have received surgical treatment for Parkinson's disease other than deep brain stimulation, such as stereotactic destruction, cell transplantation, gamma knife, etc.;2. The \"off\" state has serious language disorders, dysphagia, balance disorders and other midline symptoms;3. There are contraindications for neurosurgery, such as cerebral infarction, hydrocephalus, cerebral atrophy, ventricle enlargement, cerebrovascular sequelae, heart disease, severe thrombocytopenia and other cardiovascular and cerebrovascular diseases;4. Have other concomitant diseases, have or need to implant a pacemaker, defibrillator, cochlear implant, other neurostimulator, or need to undergo frequent magnetic examinations;5. Patients who are abnormally sensitive to temperature or allergic to heat;6. There are concomitant diseases that seriously affect health, such as tumors, serious abnormalities of liver and kidney function (indicators exceeding three times the normal value).7. Patients with anxiety and depression.","70 Years",{"count":109,"type":21},3,[111],"NA","To evaluate the safety of implantable rechargeable computer deep nerve stimulation system produced by Jiangsu Changyida Medical Technology Co., Ltd. for patients with primary Parkinson's disease",[28],"NOT_YET_RECRUITING","2024-07-07",{"date":117,"type":37},"2024-07-10",{"date":119,"type":21},"2024-07-01",{"date":121,"type":21},"2025-07-31",{"name":123,"class":124},"Jiangsu CED Medtech Co., Ltd","INDUSTRY"]