Cervical Lymphatic Microsurgery in Alzheimer's Disease
ConditionAlzheimer Disease
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorDaniel Maliszewski
About this trial
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.
Thirty 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/or 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.
The 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.
Participants 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 18 years or older
Clinical diagnosis of mild Alzheimer's disease according to National Institute on Aging-Alzheimer's Association (NIA-AA) criteria.
Clinical Dementia Rating (CDR) score of 0.5 to 1.0.
Mini-Mental State Examination (MMSE) score of 20 to 26.
Disqualifiers
Moderate or severe Alzheimer's disease.
Other neurodegenerative disorders or significant psychiatric disorders.
Previous major neck surgery or radiotherapy to the neck that may affect lymphatic drainage.
Contraindications to general anesthesia.
Trial design
Design model
Parallel
Treatments tested in this trial
Cervical Lymphatic Microsurgery
Procedure/SurgerySupermicrosurgical modification of cervical lymphatic drainage by creation of lymphaticovenous anastomosis (LVA) and/or 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.
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: Surgical InterventionExperimental treatment 1 intervention
Group B: ControlNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline to Month 12Secondary outcomes
1
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.
Time frame
Baseline to Month 122
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.
Time frame
Baseline to Month 123
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.
Time frame
Baseline to Month 124
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.
Time frame
Baseline to Month 12Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Daniel Maliszewski
Lead sponsor
Maliszewski Daniel
Sponsor institution
Janusz Korczak Provincial Specialist Hospital in Słupsk
Collaborator
University Clinical Centre, Gdansk
Collaborator
Source ClinicalTrials.gov