Alzheimer's DiseasePhase 3NCT07060391
A Prospective Multicenter RCT Study of Deep Jugular Lymphovenous Anastomosis in the Treatment of Alzheimer's Disease
A Phase 3 study testing Deep cervical lymphatic-venous anastomosis and Donepezil drug treatment in people with Alzheimer's Disease, run by Shanghai Jiao Tong University School of Medicine.
Trial summary
This research aims to observe the efficacy and safety of surgery compared with traditional medical treatment for moderate to severe dementia in Alzheimer's disease. This is a prospective multicenter RCT clinical research, involving a total of 3 research centers.Patients diagnosed with Alzheimer's disease accompanied… Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Alzheimer's Disease
- What is being tested?
- Deep cervical lymphatic-venous anastomosis and Donepezil drug treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 186 participants
- Where
- No sites listed yet
- Study dates
- 31 Jul 2025to 31 Jan 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patient was clinically diagnosed with Alzheimer's disease and had a moderate to severe cognitive function score.
- Age: 30-80 years old.
- Gender is not limited.
- The patient or their family members authorize their willingness to participate in this clinical trial and sign the informed consent form.
- no contraindications for surgery.
Who cannot join
- A history of radiotherapy or surgery for the head and neck.
- Patients or their families with poor compliance who cannot strictly follow the rules.
- Patients who cannot tolerate surgery.
- Patients with other diseases that affect cognitive function.
- Patients who cannot tolerate donepezil drug treatment.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
This research aims to observe the efficacy and safety of surgery compared with traditional medical treatment for moderate to severe dementia in Alzheimer's disease. This is a prospective multicenter RCT clinical research, involving a total of 3 research centers.Patients diagnosed with Alzheimer's disease accompanied by moderate to severe cognitive dysfunction in these three hospitals from January 2025 to January 2027 were included. This research is expected to recruit a total of 186 patients with moderate to severe Alzheimer's disease.93patients received conventional medical treatment, Deep cervical lymphatic-venous anastomosis was performed in 93 patients.Comprehensively evaluate the efficacy and safety of the patients within 48 weeks after treatment.
Read the detailed description
Alzheimer's disease is a degenerative disorder of the central nervous system characterized by progressive cognitive dysfunction and behavioral impairment. At present, the treatment strategies for Alzheimer's disease include drug therapy, non-drug therapy and some emerging treatment methods. However, clinical evidence has confirmed that the effects of these treatment measures are limited. In recent years, Some neurosurgeons in China have begun to attempt to improve the disease progression of severe Alzheimer's disease through the innovative microscopic surgical method of deep jugular lymphovenous anastomosis. The therapeutic principle is Lymph node reconstruction is carried out using microsurgical techniques to improve the lymphatic circulation and return of the brain, accelerate the excretion of pathological proteins, the metabolic products of the brain, thereby delaying the degenerative changes of the brain and the progression of Alzheimer's disease. To verify the above assumption, this study will collaborate with a total of three institutions, namely Ruijin Hospital, Luwan Branch and Wuxi Branch. It is estimated that 186 patients with moderate to severe dementia of Alzheimer's disease will be included. They were randomly divided into the surgical treatment group (93 cases) and the traditional medical treatment group (93 cases). Cognitive function assessment, PETMR imaging examination, cerebrospinal fluid/blood testing and quality-adjusted life years were analyzed respectively at the 1st week, 4th week, 12th week, 24th week and 48th week after conservative treatment or surgery. To observe the efficacy and safety of surgery compared with traditional medical treatment for moderate to severe dementia in Alzheimer's disease.
- Conditions
- Alzheimer's Disease
- Being tested
- Deep cervical lymphatic-venous anastomosis, Donepezil drug treatment
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deep cervical lymphatic-venous anastomosisProcedure or surgery
Lymph node reconstruction was carried out using microsurgical techniques,improve cerebral lymphatic circulation and return, accelerate the excretion of pathological proteins, the metabolic products of the brain, from the brain. This is to delay the degenerative changes of the brain and the progression of Alzheimer's disease.
Donepezil drug treatmentDrug
All patients stopped taking cognitive-enhancing drugs after enrollment, and marketed therapeutic drugs include ginkgo biloba, high-dose vitamin E, lecithin, estrogen, non-steroidal anti-inflammatory drugs, memegan, etc.
| Study group | Role | What they receive |
|---|---|---|
| Surgical treatment | Experimental | Deep cervical lymphatic-venous anastomosis Receives: Procedure: Deep cervical lymphatic-venous anastomosis |
| Internal medicine conservative treatment | Placebo comparator | Donepezil drug ,5-10mg,qd,po. All patients stopped taking cognitive-enhancing drugs and marketed therapeutic drugs such as ginkgo, high-dose vitamin E, lecithin, estrogen, non-steroidal anti-inflammatory drugs, Memegan, etc. after enrollment. Receives: Drug: Donepezil drug treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
ADAS-cog score
The improvement of 4 points by ADAS-cog is used as the judgment criterion for the clinical therapeutic effect, Compare the remission rates between the experimental group (surgery) and the control group (medication).
Measured: baseline,48 weeks
Secondary outcomes (5)
Imaging data
PET-MRI labeled with specific tracers shows the changes in amyloid protein or tau deposition, Quantify and statistically analyze the changes between the two groups.
Measured: From the first week to the 48th week
Cerebrospinal fluid examination
Test the Alzheimer's disease markers such as amyloid protein or tau deposition in the cerebrospinal fluid between the two groups, count the changes between the two groups.
Measured: From the first week to the 48th week
Markers of Alzheimer's disease in the blood
Test the changes of Alzheimer's disease markers such as amyloid protein in the blood between the two groups,count the changes between the two groups.
Measured: From the first week to the 48th week
Surgery-related adverse reactions
The occurrence of complications:such as postoperative bleeding,Peripheral nerve injury,Lymphatic vessel leakage,Cardiovascular and cerebrovascular events, etc.
Measured: From the first week to the 48th week
Quality-Adjusted Life Year
It is a health outcome evaluation index that comprehensively considers survival time and quality of life. The survival time and quality of life of the intervention group and the medication group were compared. The calculation method is Survival Time (years) × Health Utility Value, The health utility value is a quality weight reflecting a specific health status(1 indicates complete health, 0 indicates death, and a negative value indicates a state worse than death). The utility values of patients under different health conditions were evaluated through the Quality of life assessment scale, an assessment should be conducted every six months after treatment. Multiply the duration of each health state by the corresponding utility value. Then accumulate to obtain the Quality-Adjusted Life Year score.
Measured: From the first week to the 48th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2025
- Study start31 Jul 2025 (estimated)
- Primary completion31 Jan 2027 (estimated)
- Study completion31 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer's DiseaseStudies of the same condition, open and under way.
- More trials run by Shanghai Jiao Tong University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 186 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Jiao Tong University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yijun Cheng, Shanghai Jiao Tong University School of Medicine
- Investigators
- Yijun Cheng, Doc, Principal investigator, Ruijin HospitalHanbing Shang, Principal investigator, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07060391
- Sponsor's protocol ID
- DCLVA
- Status last verified
- Jun 2025
- First submitted
- 22 Jun 2025
- Last updated
- 11 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Multicenter RCT Study of Deep Jugular Lymphovenous Anastomosis in the Treatment of Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT07060391
- Acronym / sponsor ID
- DCLVA
- Conditions
- Alzheimer's Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 186 participants (estimated)
- Lead sponsor
- Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- 31 Jul 2025 (estimated)
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 11 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This research aims to observe the efficacy and safety of surgery compared with traditional medical treatment for moderate to severe dementia in Alzheimer's disease. This is a prospective multicenter RCT clinical research, involving a total of 3 research centers.Patients diagnosed with Alzheimer's disease accompanied by moderate to severe cognitive dysfunction in these three hospitals from January 2025 to January 2027 were included. This research is expected to recruit a total of 186 patients with moderate to severe Alzheimer's disease.93patients received conventional medical treatment, Deep cervical lymphatic-venous anastomosis was performed in 93 patients.Comprehensively evaluate the efficacy and safety of the patients within 48 weeks after treatment.
Detailed description
Alzheimer's disease is a degenerative disorder of the central nervous system characterized by progressive cognitive dysfunction and behavioral impairment. At present, the treatment strategies for Alzheimer's disease include drug therapy, non-drug therapy and some emerging treatment methods. However, clinical evidence has confirmed that the effects of these treatment measures are limited. In recent years, Some neurosurgeons in China have begun to attempt to improve the disease progression of severe Alzheimer's disease through the innovative microscopic surgical method of deep jugular lymphovenous anastomosis. The therapeutic principle is Lymph node reconstruction is carried out using microsurgical techniques to improve the lymphatic circulation and return of the brain, accelerate the excretion of pathological proteins, the metabolic products of the brain, thereby delaying the degenerative changes of the brain and the progression of Alzheimer's disease. To verify the above assumption, this study will collaborate with a total of three institutions, namely Ruijin Hospital, Luwan Branch and Wuxi Branch. It is estimated that 186 patients with moderate to severe dementia of Alzheimer's disease will be included. They were randomly divided into the surgical treatment group (93 cases) and the traditional medical treatment group (93 cases). Cognitive function assessment, PETMR imaging examination, cerebrospinal fluid/blood testing and quality-adjusted life years were analyzed respectively at the 1st week, 4th week, 12th week, 24th week and 48th week after conservative treatment or surgery. To observe the efficacy and safety of surgery compared with traditional medical treatment for moderate to severe dementia in Alzheimer's disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Surgical treatment | Experimental | Procedure: Deep cervical lymphatic-venous anastomosisDeep cervical lymphatic-venous anastomosis |
| Internal medicine conservative treatment | Placebo comparator | Drug: Donepezil drug treatmentDonepezil drug ,5-10mg,qd,po. All patients stopped taking cognitive-enhancing drugs and marketed therapeutic drugs such as ginkgo, high-dose vitamin E, lecithin, estrogen, non-steroidal anti-inflammatory drugs, Memegan, etc. after enrollment. |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- The patient was clinically diagnosed with Alzheimer's disease and had a moderate to severe cognitive function score.
- Age: 30-80 years old.
- Gender is not limited.
- The patient or their family members authorize their willingness to participate in this clinical trial and sign the informed consent form.
- no contraindications for surgery.
Key exclusion criteria (5 listed)
- A history of radiotherapy or surgery for the head and neck.
- Patients or their families with poor compliance who cannot strictly follow the rules.
- Patients who cannot tolerate surgery.
- Patients with other diseases that affect cognitive function.
- Patients who cannot tolerate donepezil drug treatment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Deep cervical lymphatic-venous anastomosisLymph node reconstruction was carried out using microsurgical techniques,improve cerebral lymphatic circulation and return, accelerate the excretion of pathological proteins, the metabolic products of the brain, from the brain. This is to delay the degenerative changes of the brain and the progression of Alzheimer's disease. | Procedure or surgery | Surgical treatment |
| Donepezil drug treatmentAll patients stopped taking cognitive-enhancing drugs after enrollment, and marketed therapeutic drugs include ginkgo biloba, high-dose vitamin E, lecithin, estrogen, non-steroidal anti-inflammatory drugs, memegan, etc. | Drug | Internal medicine conservative treatment |
Primary outcome
ADAS-cog score
Time frame: baseline,48 weeks
The improvement of 4 points by ADAS-cog is used as the judgment criterion for the clinical therapeutic effect, Compare the remission rates between the experimental group (surgery) and the control group (medication).
5 secondary outcomes
Imaging data
Time frame: From the first week to the 48th week
Cerebrospinal fluid examination
Time frame: From the first week to the 48th week
Markers of Alzheimer's disease in the blood
Time frame: From the first week to the 48th week
Surgery-related adverse reactions
Time frame: From the first week to the 48th week
Quality-Adjusted Life Year
Time frame: From the first week to the 48th week
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yijun Cheng, Doc principal investigator
Ruijin Hospital
Hanbing Shang principal investigator
Ruijin Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Deep cervical lymphatic-venous anastomosis and Donepezil drug treatment in people with Alzheimer's Disease, run by Shanghai Jiao Tong University School of Medicine.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 11 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yijun Cheng, Doc (15021058538, cyj12574@rjh.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ADAS-cog score (time frame: baseline,48 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2025.