[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658925":3},{"organization":4,"outcomesModule":7,"designInfo":41,"detailedDescription":40,"studyPopulation":40,"armGroups":50,"interventions":61,"overallOfficials":40,"centralContacts":70,"locations":80,"responsibleParty":112,"collaborators":116,"id":122,"slug":123,"hasResults":124,"nctId":125,"briefTitle":126,"officialTitle":127,"acronym":40,"eligibilityCriteria":128,"healthyVolunteers":124,"sex":129,"minAge":130,"maxAge":40,"enrollmentInfo":131,"targetDuration":40,"studyType":134,"phases":135,"briefSummary":137,"conditions":138,"keywords":140,"overallStatus":83,"whyStopped":40,"lastUpdateSubmitDate":147,"lastUpdatePostDateStruct":148,"startDateStruct":151,"completionDateStruct":153,"leadSponsor":155,"locationsCount":156},{"fullName":5,"class":6},"Maliszewski Daniel","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":40},[9],{"measure":10,"description":11,"timeFrame":12},"Change in Plasma Phosphorylated Tau 217 (p-tau217) Concentration From Baseline to Month 12","Change in plasma phosphorylated tau 217 (p-tau217) concentration from baseline to the 12-month follow-up. The change over time will be compared between the surgical intervention and control groups.","Baseline to Month 12",[14,17,20,23,26,30,33,37],{"measure":15,"description":16,"timeFrame":12},"Change in CDR-SB Score From Baseline to Month 12","The Clinical Dementia Rating Sum of Boxes (CDR-SB) score ranges from 0 to 18, with higher scores indicating greater cognitive and functional impairment and therefore a worse clinical outcome. Change in CDR-SB score from baseline to Month 12 will be compared between the surgical intervention and control groups. A positive change from baseline indicates worsening, whereas a negative change indicates improvement.",{"measure":18,"description":19,"timeFrame":12},"Change in ADCS-ADL Score From Baseline to Month 12","The 23-item Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADCS-ADL) total score ranges from 0 to 78, with higher scores indicating better performance in activities of daily living and therefore a better functional outcome. Change in ADCS-ADL total score from baseline to Month 12 will be compared between the surgical intervention and control groups. A positive change from baseline indicates improvement, whereas a negative change indicates worsening.",{"measure":21,"description":22,"timeFrame":12},"Change in MoCA Score From Baseline to Month 12","The Montreal Cognitive Assessment (MoCA) total score ranges from 0 to 30, with higher scores indicating better cognitive performance and therefore a better cognitive outcome. Change in MoCA total score from baseline to Month 12 will be compared between the surgical intervention and control groups. A positive change from baseline indicates improvement, whereas a negative change indicates worsening.",{"measure":24,"description":25,"timeFrame":12},"Change in MMSE Score From Baseline to Month 12","The Mini-Mental State Examination (MMSE) total score ranges from 0 to 30, with higher scores indicating better cognitive performance and therefore a better cognitive outcome. Change in MMSE total score from baseline to Month 12 will be compared between the surgical intervention and control groups. A positive change from baseline indicates improvement, whereas a negative change indicates worsening.",{"measure":27,"description":28,"timeFrame":29},"Procedure-Related Adverse Events and Serious Adverse Events","Occurrence of adverse events and serious adverse events related to the surgical procedure during the study follow-up period.","From surgery through Month 12",{"measure":31,"description":32,"timeFrame":29},"Postoperative Complications","Occurrence of postoperative complications following cervical lymphatic microsurgery, including local surgical complications assessed during follow-up.",{"measure":34,"description":35,"timeFrame":36},"Rehospitalization","Occurrence of rehospitalization during the 12-month study follow-up period.","Up to Month 12",{"measure":38,"description":39,"timeFrame":36},"All-Cause Mortality","Occurrence of death from any cause during the 12-month study follow-up period.",null,{"allocation":42,"interventionModel":43,"interventionModelDescription":44,"primaryPurpose":45,"observationalModel":40,"timePerspective":40,"maskingInfo":46},"RANDOMIZED","PARALLEL","Randomized, parallel-group pilot study with 1:1 block randomization to surgical intervention or clinical observation without surgery during the first 12 months. After completion of the 12-month observation period, control participants may elect to undergo the surgical procedure.","BASIC_SCIENCE",{"masking":47,"maskingDescription":40,"whoMasked":48},"SINGLE",[49],"OUTCOMES_ASSESSOR",[51,57],{"label":52,"type":53,"description":54,"interventionNames":55},"Surgical Intervention","EXPERIMENTAL","Participants assigned to this arm will undergo supermicrosurgical modification of cervical lymphatic drainage using lymphaticovenous anastomosis (LVA) and\u002For lymph node-to-vein anastomosis (LNVA). The procedure may be performed manually or with robotic microsurgical assistance.",[56],"Procedure: Cervical Lymphatic Microsurgery",{"label":58,"type":59,"description":60,"interventionNames":40},"Control","NO_INTERVENTION","Participants assigned to this arm will undergo clinical observation without surgical intervention during the first 12 months. After completion of the 12-month observation period, participants may elect to undergo the surgical procedure.",[62],{"type":63,"name":64,"description":65,"armGroupLabels":66,"otherNames":67},"PROCEDURE","Cervical Lymphatic Microsurgery","Supermicrosurgical modification of cervical lymphatic drainage by creation of lymphaticovenous anastomosis (LVA) and\u002For lymph node-to-vein anastomosis (LNVA). Preoperative lymphatic and venous mapping is performed using ultra-high-frequency ultrasound and indocyanine green fluorescence imaging. The procedure is performed under general anesthesia and may be carried out manually or with robotic supermicrosurgical assistance. The specific anastomotic technique and configuration are selected according to the identified lymphatic and venous anatomy.",[52],[68,69],"Lymph Node-to-Vein Anastomosis (LNVA)","Lymphaticovenous Anastomosis (LVA)",[71,76],{"name":72,"role":73,"phone":74,"phoneExt":40,"email":75},"Daniel Maliszewski, MD, PhD","CONTACT","+48 501784896","danielmal2@gmail.com",{"name":77,"role":73,"phone":78,"phoneExt":40,"email":79},"Kamil Chwojnicki, MD, PhD","+48 506135515","kchwoj@gumed.edu.pl",[81,99],{"facility":82,"status":83,"city":84,"state":40,"zip":85,"country":86,"countryCode":87,"cosmosGeoPoint":88,"geoPoint":93,"contacts":94},"Uniwersyteckie Centrum Kliniczne w Gdańsku","RECRUITING","Gdansk","80-952","Poland","PL",{"type":89,"coordinates":90},"Point",[91,92],18.64912,54.35227,{"lat":92,"lon":91},[95,97],{"name":77,"role":73,"phone":96,"phoneExt":40,"email":79},"+48 506 135 515",{"name":77,"role":98,"phone":40,"phoneExt":40,"email":40},"PRINCIPAL_INVESTIGATOR",{"facility":100,"status":83,"city":101,"state":40,"zip":102,"country":86,"countryCode":87,"cosmosGeoPoint":103,"geoPoint":107,"contacts":108},"Wojewódzki Szpital Specjalistyczny im. Janusza Korczaka w Słupsku Sp. z o.o.","Słupsk","76-200",{"type":89,"coordinates":104},[105,106],17.02872,54.46405,{"lat":106,"lon":105},[109,111],{"name":72,"role":73,"phone":110,"phoneExt":40,"email":75},"+48 501 784 896",{"name":72,"role":98,"phone":40,"phoneExt":40,"email":40},{"type":113,"investigatorFullName":114,"investigatorTitle":115,"investigatorAffiliation":5,"oldNameTitle":40,"oldOrganization":40},"SPONSOR_INVESTIGATOR","Daniel Maliszewski","Specialist in General Surgery",[117,120],{"name":118,"class":119},"Janusz Korczak Provincial Specialist Hospital in Słupsk","UNKNOWN",{"name":121,"class":6},"University Clinical Centre, Gdansk","100658925","cervical-lymphatic-microsurgery-in-alzheimers-disease-100658925",false,"NCT07857759","Cervical Lymphatic Microsurgery in Alzheimer's Disease","Microsurgical Modification of Cervical Lymphatic Pathways in Alzheimer's Disease: A Pilot Study","Inclusion Criteria:\n\n* Age 18 years or older\n* Clinical diagnosis of mild Alzheimer's disease according to National Institute on Aging-Alzheimer's Association (NIA-AA) criteria.\n* Clinical Dementia Rating (CDR) score of 0.5 to 1.0.\n* Mini-Mental State Examination (MMSE) score of 20 to 26.\n* Confirmation of Alzheimer's disease pathology using plasma biomarkers, with elevated phosphorylated tau 217 (p-tau217).\n* Stable pharmacological treatment for Alzheimer's disease for at least 3 months before enrollment.\n* Ability to provide informed consent or consent provided by a legally authorized representative.\n\nExclusion Criteria:\n\n* Moderate or severe Alzheimer's disease.\n* Other neurodegenerative disorders or significant psychiatric disorders.\n* Previous major neck surgery or radiotherapy to the neck that may affect lymphatic drainage.\n* Contraindications to general anesthesia.\n* Active infection or coagulation disorders.","ALL","18 Years",{"count":132,"type":133},30,"ESTIMATED","INTERVENTIONAL",[136],"NA","This pilot study will evaluate whether microsurgical modification of cervical lymphatic drainage may influence blood biomarkers and clinical outcomes in people with mild Alzheimer's disease.\n\nThirty participants will be randomly assigned in a 1:1 ratio to either a surgical intervention group or a control group. Participants in the intervention group will undergo supermicrosurgical lymphaticovenous anastomosis (LVA) and\u002For lymph node-to-vein anastomosis (LNVA) in the neck to create an alternative pathway for lymphatic drainage. The procedure may be performed manually or with robotic microsurgical assistance. Participants in the control group will receive clinical observation without surgery during the first 12 months.\n\nThe primary objective is to assess the change in plasma phosphorylated tau 217 (p-tau217) from baseline to 12 months. The study will also assess changes in cognitive and functional measures, including the Clinical Dementia Rating Sum of Boxes (CDR-SB), Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADCS-ADL), Montreal Cognitive Assessment (MoCA), and Mini-Mental State Examination (MMSE), as well as the feasibility and safety of the surgical procedure.\n\nParticipants will be assessed at baseline and at 3, 6, and 12 months. After completion of the 12-month observation period, participants in the control group may be offered the surgical procedure if they wish to undergo it.",[139],"Alzheimer Disease",[141,142,143,144,145,146],"Mild Alzheimer Disease","Cervical Lymphatic Drainage","Lymphovenous Anastomosis","Lymph Node-to-Vein Anastomosis","Supermicrosurgery","Phosphorylated Tau 217","2026-10-05",{"date":149,"type":150},"2026-10-08","ACTUAL",{"date":152,"type":133},"2026-09",{"date":154,"type":133},"2029-05",{"name":114,"class":6},2]