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Deep Cervical Lymphatlc-Venous Anastomosis Surgery for the Treatment of Alzheimer's Disease: A Pilot Study (DIVA Study)

NCT06530732 · Zhejiang Provincial People's Hospital
In plain English

Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.

About this study
This study aims to enroll patients diagnosed with AD. Patients who meet the inclusion and exclusion criteria and consent to participate will be randomly assigned to either the experimental group (receiving dcLVA surgery plus standard medication) or the control group (receiving standard medication alone). Following randomization, patients will undergo cognitive and brain MRI assessments, a lumbar puncture, and an injection of 20ml of gadodiamide contrast agent at a concentration of 0.5 mmol/L (1ml gadodiamide: 20ml 0.9% saline). MRI imaging scans will be conducted at 4 hours, 24 hours, and 48 hours post-injection to measure the dural signal unit ratio, which will be used to assess glymphatic clearance function. The study will track changes in cognitive function and glymphatic clearance function at baseline and during follow-up periods (7 days post-surgery, 6 months, and 12 months) and will evaluate the safety of the two treatment approaches.
Eligibility criteria
Inclusion Criteria: * Diagnosed as an AD patient according to biological markers and clinical symptoms; * Over 35 years old and with an MMSE or MOCA score ≤ 26; * The patient or family member has signed an informed consent form. Exclusion Criteria: * Inability to cooperate with lumbar puncture; * Cognitive impairment due to neurological infections (e.g., HIV, neurosyphilis, autoimmune encephalitis) or systemic diseases (e.g., diabetes, thyroid dysfunction); * Significant organ dysfunction (heart, lung, liver, kidney); * Coagulation disorders or contraindications to surgery; * Inability to fully cooperate with follow-up visits.
Study design
Enrollment target: 60 participants
Allocation: randomized
Masking: none
Age groups: child, adult, older_adult
Timeline
Starts: 2024-07-01
Estimated completion: 2026-09-30
Last updated: 2025-01-16
Interventions
Procedure: Deep Cervical lymphatlc-Venous Anastomosis SurgeryDrug: Lecanemab
Primary outcomes
  • The rate of change in the total score of the Clinical Dementia Rating Scale (Time Frame: baseline,7 days post-surgery,3-month,6-month and 12-month)
Sponsor
Zhejiang Provincial People's Hospital · other
All locations (1)
Zhejiang Provincial People's HospitalRecruiting
Hangzhou, Zhejiang, China
Deep Cervical Lymphatlc-Venous Anastomosis Surgery for the Treatment of Alzheimer's Disease: A Pilot Study (DIVA Study) · TrialPath