NCT07680660
Efficacy of Lymphatic-Venous Anastomosis Plus Donepezil Versus Donepezil Alone for Alzheimer's Disease
Not Yet Recruiting · Not Applicable · Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University · registry updated 2026-07-22
Inclusion and exclusion lines below are quoted from ClinicalTrials.gov. No match score is shown, because a score needs a person's age, biomarkers, and treatment dates. Confirm the record with the study team.
This study employed a multicenter, randomized controlled trial (RCT) design to evaluate the efficacy and safety of deep cervical lymphatic/lymph node-venous anastomosis combined with oral donepezil compared to donepezil monotherapy in patients with Alzheimer's disease and moderate dementia. Participants were randomized using a central randomization system with stratified block design, with the study center and age group (50-64 years, 65-80 years) as stratification factors. While study participants and surgical investigators could not be blinded due to the nature of the intervention, efficacy assessors and imaging specialists remained blinded to ensure the objectivity and reliability of the findings. The intervention group received deep cervical lymphatic/lymph node-venous anastomosis (detailed surgical procedure is specified in the protocol) in combination with oral donepezil (5-10 mg/day), while the control group received oral donepezil alone. The total treatment and follow-up period was 18 months, with assessments conducted at baseline, 1 week, 1, 3, 6, 12, and 18 months post-operation....
Inclusion
- The patient or guardian signs the informed consent form;
- Age 50-80 years (≥50 years, ≤80 years), male or female;
- The first diagnosis is Alzheimer's disease with dementia;
- MMSE score ≤24;
- Positive β-amyloid protein PET imaging findings;
- HAMD score ≤17;
Exclusion
- Presence of contraindications to MRI, ICG angiography, or PET scan;
- Presence of contraindications to lumbar puncture;
- Severe heart disease or unstable hemodynamic status;
- Severe lung disease, including severe obstructive, restrictive, or mixed ventilatory dysfunction, or acute inflammation within 3 months;
- Hepatic insufficiency, AST or ALT \>3 times the upper limit of normal;
- Renal insufficiency, GFR \<60 mL/min or need for blood purification treatment;