An interventional study of Deep cervical lymphovenous anastomosis (LVA) and Routine Treatment in Alzheimer's Disease, sponsored by Southwest Hospital, China. Not yet recruiting at 1 site in China. Open to participants aged 50 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-06-22.
Sponsored by Southwest Hospital, China · Not applicable, Interventional, and Treatment
This is a multicenter, prospective, open-label, endpoint-blinded randomized controlled clinical study. We aim to evaluate the safety and efficacy of deep cervical lymphovenous anastomosis (LVA) combined with routine treatment for patients with moderate Alzheimer's disease, compared with routine treatment alone.
A total of 296 eligible participants aged 50 to 80 years with moderate Alzheimer's disease will be enrolled and randomly divided into two groups at a 1:1 ratio. One group will receive deep cervical lymphovenous anastomosis plus standard routine treatment, while the other group will only receive standard routine treatment for Alzheimer's disease.
All participants will be followed up for 12 months after randomization. We will assess cognitive function using MMSE and CDR-SB scales, evaluate caregiver burden via ZBI scale, and detect changes in Alzheimer's disease related biomarkers including blood amyloid-beta and tau protein, as well as Aβ-PET imaging indicators. The main goal is to observe whether this surgical procedure can improve patients' neurological function and clear abnormal protein deposits in the brain, and confirm its long-term safety.
This study strictly follows ethical principles. Every participant or their legal representative will sign a written informed consent before enrollment. During the whole study period, we will closely monitor all adverse events to ensure the safety of participants.
Study Design and Objectives This is an interventional, multicenter, randomized, parallel-group, open-label and endpoint-blinded clinical trial. The primary objective is to verify the efficacy and safety of deep cervical lymphovenous anastomosis (LVA) in patients with moderate Alzheimer's disease. The secondary objectives include analyzing the changes of cognitive function, caregiver burden and cerebral amyloid-beta deposition within 12 months after intervention, and exploring the variation characteristics of peripheral blood biomarkers.
Study Population Eligible participants are patients diagnosed with probable Alzheimer's dementia consistent with 2011 NIA-AA clinical criteria and 2018 NIA-AA biomarker framework. Inclusion criteria: age 50 to 80 years; MMSE score between 10 and 20 points (moderate cognitive impairment); progressive cognitive decline for more than 6 months; no clinical improvement after more than six months of drug treatment; having a designated companion who can accompany follow-up and provide informed consent. Subjects with severe organ dysfunction, recent intracranial injury, drug allergy to study related reagents, PET contraindications or other severe mental disorders will be excluded.
Intervention and Control Measures Participants are randomly assigned to two groups by EDC system at a 1:1 ratio. Intervention group: Bilateral deep cervical lymphovenous anastomosis plus conventional symptomatic treatment for Alzheimer's disease. The operation is performed under surgical microscope with indocyanine green (ICG) lymphatic tracing technology. Postoperative routine anti-inflammatory treatment and rehabilitation training will be conducted.
Control group: Receive only standard drug treatment and routine rehabilitation training for Alzheimer's disease, without surgical intervention.
Evaluation Indicators and Time Points The primary outcome measure is the change of CDR-SB score from baseline to 12 months after randomization. Secondary outcome measures include changes in CDR-SB score at 1 month and 6 months, changes in MMSE and ZBI scores at 1, 6 and 12 months, and changes of Aβ-PET Centiloid value at 12 months. Exploratory indicators cover peripheral blood Aβ42, Aβ40, Aβ42/40 ratio, t-tau, p-tau and other biomarkers at each follow-up time point.
All assessments will be conducted at baseline, 1 month (±7 days), 6 months (±15 days) and 12 months (±15 days) after randomization. All adverse events, vital signs, laboratory tests, electrocardiogram and imaging findings will be continuously collected to evaluate the safety profile of the surgical procedure.
Randomization and Blinding Method Randomization is implemented via electronic data capture (EDC) system. Due to the nature of surgical intervention, participants, surgeons and clinical researchers cannot be blinded. However, all outcome assessors and statistical analysts are fully blinded to group allocation to reduce assessment bias. All raters will be shielded from patients' surgical scars during scale evaluation.
Statistical Analysis The full analysis set (FAS) will be adopted for primary efficacy analysis based on the intention-to-treat principle. Per-protocol set (PPS) will be used for sensitivity analysis, and safety analysis will be performed based on safety analysis set (SAS). Mixed-effects model for repeated measures (MMRM) and analysis of covariance (ANCOVA) will be applied for data analysis. Missing data will be handled by last observation carried forward (LOCF) method. Subgroup analyses stratified by APOEε4 status, age and baseline cognitive level will also be performed.
Ethical Requirements The whole study complies with the Declaration of Helsinki and relevant Chinese clinical research regulations. The study has been reviewed and approved by the Ethics Committee of the First Affiliated Hospital of Army Medical University. Written informed consent will be obtained from each participant or their legal surrogate before any study-related procedures. Vulnerable population protection measures are strictly implemented for patients with cognitive impairment.
3,965 studies on the registry are indexed under Alzheimer Disease; 926 are open to participants now.
This study's planned enrollment of 296 is above the median of 70 across 3,019 interventional studies indexed under Alzheimer Disease.
Browse Alzheimer Disease studies →Southwest Hospital, China is the lead sponsor of 87 studies on the registry; 15 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants undergo bilateral deep cervical lymphovenous anastomosis (LVA), combined with standard routine drug treatment for moderate Alzheimer's disease.
Procedure: Deep cervical lymphovenous anastomosis (LVA) · Other: Routine Treatment
Participants receive only standard routine drug treatment for moderate Alzheimer's disease, with no surgical procedure performed.
Other: Routine Treatment
A microsurgical lymphatic drainage procedure performed under operative microscope with ICG lymphography tracing. Bilateral deep cervical lymphovenous anastomosis is conducted to improve cerebral lymphatic clearance in patients with moderate Alzheimer's disease.
Participants receive only standard routine drug treatment for moderate Alzheimer's disease, with no surgical procedure performed.
Change in CDR-SB score from baseline to 12 months after randomization
Change of Clinical Dementia Rating-Sum of Boxes (CDR-SB) score at 12 months compared with baseline, to evaluate overall cognitive and functional status of patients with moderate Alzheimer's disease.
Time frame: 12 months after randomization
Change in CDR-SB score at 1 month and 6 months after randomization
Serial changes of CDR-SB score at 1 month and 6 months post randomization.
Time frame: 1 month, 6 months after randomization
Change in MMSE score
Change of Mini-Mental State Examination (MMSE) score reflecting general cognitive function.
Time frame: 1 month, 6 months, 12 months after randomization
Change in Zarit Burden Interview (ZBI) score
Change of caregiver burden assessed by Zarit Burden Interview scale.
Time frame: 1 month, 6 months, 12 months after randomization
Change in Aβ-PET Centiloid value
Variation of cerebral amyloid-beta deposition measured by Aβ-PET imaging.
Time frame: 12 months after randomization
Plan to share: No — Individual participant data will not be shared externally to protect participants' personal privacy and comply with domestic clinical research regulations. All trial data are stored securely for internal use, inspection and audit only, and will not be provided to outside researchers without formal approval from the ethics committee.
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Southwest Hospital, China