Alzheimer DiseaseNCT07294885
Deep Cervical LymphatIc-Venous Anastomosis for Alzheimer's Disease
A study testing deep cervical lymphaticovenous anastomosis in people with Alzheimer Disease, run by General Hospital of Shenyang Military Region at 1 site in China.
Trial summary
Lymphaticovenous anastomosis (LVA) is a microsurgical technique that involves anastomosing fine lymphatic vessels with adjacent veins to reestablish lymphatic drainage pathways. It is used in the treatment of lymphedema-related conditions and is characterized by minimal invasiveness and rapid recovery. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- deep cervical lymphaticovenous anastomosis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 20 Mar 2026to 30 Aug 2027
- Phase
- Interventional
- 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 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 50-80 years (inclusive), regardless of gender.
- Meeting the diagnostic criteria for Mild Cognitive Impairment or mild to moderate dementia due to Alzheimer's disease (according to the 2024 AA clinical diagnostic criteria for AD-related dementia).
- Disease duration of 6 months or longer, with no clinical improvement after 3 months or more of conservative treatment.
- MMSE score: 12-26.
- Biomarker confirmation of AD: positive Aβ-PET and tau-PET, or positive cerebrospinal fluid biomarkers.
- Having a reliable caregiver (providing companionship for ≥3 hours per day).
- Signed written informed consent from the patient or legally authorized representative.
Who cannot join
- Contraindications to MRI, ICG angiography, or PET.
- Contraindications to surgery or anesthesia, such as coagulation disorders (platelet count <100×10⁹/L, INR >1.7).
- Comorbid major organ dysfunction, such as reduced left ventricular ejection fraction, severe hepatic or renal insufficiency (AST or ALT >3 times the upper limit of normal; eGFR <30 mL/min/1.73m²).
- Intracranial structural lesions indicated by MRI, including brain tumors, cerebral infarction, intracranial hemorrhage, aneurysms, arteriovenous malformations, hydrocephalus, etc.
- MRI findings suggestive of significant cerebral small vessel disease features: more than one lacunar infarction in the deep white matter and periventricular regions and/or white matter hyperintensity (WMH) with a Fazekas grade >2, or the presence of ≥4 cerebral microbleeds.
- Other causes of dementia, such as hypothyroidism or vitamin B12 deficiency.
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- Drug/alcohol addiction.
- Severe psychiatric illness or suicide risk.
- Comorbid medical conditions with a life expectancy of less than 1 year.
- Participation in another interventional trial within the past 3 months.
- Poor compliance or judged by the investigator as unsuitable for participation.
- Patients receiving therapy with Lecanemab or Donanemab.
- Other conditions that the researcher deems unsuitable for participation in this study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Department of Neurology, General Hospital of Northern Theater Command
Shenyang, 110016
Hui-Sheng Chen, Ph.D., +86 13352452086, chszh@aliyun.com
About this study
Official title: Deep Cervical LymphatIc-Venous Anastomosis for Alzheimer's Disease (CLIVA-AD): a Prospective, Single-center, Randomized, Double Blinded Trial
Lymphaticovenous anastomosis (LVA) is a microsurgical technique that involves anastomosing fine lymphatic vessels with adjacent veins to reestablish lymphatic drainage pathways. It is used in the treatment of lymphedema-related conditions and is characterized by minimal invasiveness and rapid recovery. Based on findings from animal studies, some physicians in China have attempted deep cervical lymphatic-venous anastomosis to improve intracranial lymphatic drainage in patients with Alzheimer's disease (AD). Most studies, including those from our center, have observed early postoperative improvements in various domains such as mood, memory, executive function, and communication abilities in the majority of patients. However, these symptomatic improvements are not sustained. The reasons for the early improvements remain unclear. Are they due to enhanced lymphatic drainage resulting from the surgery itself, or are they attributable to other factors such as anesthetic effects, vascular release, or modulation of sympathetic nerves? Therefore, it is necessary to conduct a randomized controlled trial with a sham surgery group to clarify the causes of early clinical symptom improvements. Based on this, this project aims to carry out a prospective, single-center, randomized double-blind controlled study to evaluate whether the early symptomatic improvements following deep cervical LVA in AD patients are attributable to the surgical intervention itself or to other aspects of the procedure.
- Conditions
- Alzheimer Disease
- Being tested
- deep cervical lymphaticovenous anastomosis
- 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 lymphaticovenous anastomosisProcedure or surgery
patients will receive deep cervical lymphaticovenous anastomosis
| Study group | Role | What they receive |
|---|---|---|
| LVA group | Experimental | patients will receive lymphaticovenous anastomosis Receives: Procedure: deep cervical lymphaticovenous anastomosis |
| Sham group | Sham comparator | patients will undergo the LVA surgical procedure without performing the lymphaticovenous anastomosis. Receives: Procedure: deep cervical lymphaticovenous anastomosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Montreal Cognitive Assessment (MoCA) score
MoCA ranges from 0 to 30, with higher score meaning better outcome
Measured: 4±1 days
Changes in Mini-mental State Examination (MMSE) score
MMSE ranges from 0 to 30, with higher score meaning better outcome
Measured: 4±1 days
Changes in Barthel index (BI)
BI ranges from 0 to 100, with higher score meaning better outcome
Measured: 4±1 days
Changes in Clinician's Interview-Based Impression of Change-plus caregiver input (CIBIC-plus)
CIBIC-plus ranges from 1 to 7, with higher score meaning worse outcome
Measured: 4±1 days
Secondary outcomes (5)
Changes in Montreal Cognitive Assessment (MoCA) score
MoCA ranges from 0 to 30, with higher score meaning better outcome
Measured: 90±7 days; 180±15 days; 270±20 days
Changes in Mini-mental State Examination (MMSE) score
MMSE ranges from 0 to 30, with higher score meaning better outcome
Measured: 90±7 days; 180±15 days; 270±20 days
Changes in Barthel index (BI)
BI ranges from 0 to 100, with higher score meaning better outcome
Measured: 90±7 days; 180±15 days; 270±20 days
Changes in Clinician's Interview-Based Impression of Change-plus caregiver input (CIBIC-plus)
CIBIC-plus ranges from 1 to 7, with higher score meaning worse outcome
Measured: 90±7 days; 180±15 days; 270±20 days
Severe adverse events
Measured: Perioperative period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2025
- Study start20 Mar 2026
- Primary completion30 Aug 2027 (estimated)
- Study completion30 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- General Hospital of Shenyang Military Region
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hui-Sheng Chen, General Hospital of Shenyang Military Region
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07294885
- Sponsor's protocol ID
- Y (2025) 250
- Status last verified
- Mar 2026
- First submitted
- 8 Dec 2025
- Last updated
- 25 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Deep Cervical LymphatIc-Venous Anastomosis for Alzheimer's Disease (CLIVA-AD): a Prospective, Single-center, Randomized, Double Blinded Trial
- ClinicalTrials.gov ID
- NCT07294885
- Acronym / sponsor ID
- Y (2025) 250
- Conditions
- Alzheimer Disease
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- General Hospital of Shenyang Military RegionUniversity, hospital or other
- Study start
- 20 Mar 2026 (actual)
- Primary completion
- 30 Aug 2027 (estimated)
- Study completion
- 30 Aug 2027 (estimated)
- First posted
- 19 Dec 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.
Lymphaticovenous anastomosis (LVA) is a microsurgical technique that involves anastomosing fine lymphatic vessels with adjacent veins to reestablish lymphatic drainage pathways. It is used in the treatment of lymphedema-related conditions and is characterized by minimal invasiveness and rapid recovery. Based on findings from animal studies, some physicians in China have attempted deep cervical lymphatic-venous anastomosis to improve intracranial lymphatic drainage in patients with Alzheimer's disease (AD). Most studies, including those from our center, have observed early postoperative improvements in various domains such as mood, memory, executive function, and communication abilities in the majority of patients. However, these symptomatic improvements are not sustained. The reasons for the early improvements remain unclear. Are they due to enhanced lymphatic drainage resulting from the surgery itself, or are they attributable to other factors such as anesthetic effects, vascular release, or modulation of sympathetic nerves? Therefore, it is necessary to conduct a randomized controlled trial with a sham surgery group to clarify the causes of early clinical symptom improvements. Based on this, this project aims to carry out a prospective, single-center, randomized double-blind controlled study to evaluate whether the early symptomatic improvements following deep cervical LVA in AD patients are attributable to the surgical intervention itself or to other aspects of the procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LVA group | Experimental | Procedure: deep cervical lymphaticovenous anastomosispatients will receive lymphaticovenous anastomosis |
| Sham group | Sham comparator | Procedure: deep cervical lymphaticovenous anastomosispatients will undergo the LVA surgical procedure without performing the lymphaticovenous anastomosis. |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age 50-80 years (inclusive), regardless of gender.
- Meeting the diagnostic criteria for Mild Cognitive Impairment or mild to moderate dementia due to Alzheimer's disease (according to the 2024 AA clinical diagnostic criteria for AD-related dementia).
- Disease duration of 6 months or longer, with no clinical improvement after 3 months or more of conservative treatment.
- MMSE score: 12-26.
- Biomarker confirmation of AD: positive Aβ-PET and tau-PET, or positive cerebrospinal fluid biomarkers.
Key exclusion criteria (13 listed)
- Contraindications to MRI, ICG angiography, or PET.
- Contraindications to surgery or anesthesia, such as coagulation disorders (platelet count <100×10⁹/L, INR >1.7).
- Comorbid major organ dysfunction, such as reduced left ventricular ejection fraction, severe hepatic or renal insufficiency (AST or ALT >3 times the upper limit of normal; eGFR <30 mL/min/1.73m²).
- Intracranial structural lesions indicated by MRI, including brain tumors, cerebral infarction, intracranial hemorrhage, aneurysms, arteriovenous malformations, hydrocephalus, etc.
- MRI findings suggestive of significant cerebral small vessel disease features: more than one lacunar infarction in the deep white matter and periventricular regions and/or white matter hyperintensity (WMH) with a Fazekas grade >2, or the presence of ≥4 cerebral microbleeds.
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 lymphaticovenous anastomosispatients will receive deep cervical lymphaticovenous anastomosis | Procedure or surgery | LVA group, Sham group |
Primary outcome
Changes in Montreal Cognitive Assessment (MoCA) score
Time frame: 4±1 days
MoCA ranges from 0 to 30, with higher score meaning better outcome
Changes in Mini-mental State Examination (MMSE) score
Time frame: 4±1 days
MMSE ranges from 0 to 30, with higher score meaning better outcome
Changes in Barthel index (BI)
Time frame: 4±1 days
BI ranges from 0 to 100, with higher score meaning better outcome
Changes in Clinician's Interview-Based Impression of Change-plus caregiver input (CIBIC-plus)
Time frame: 4±1 days
CIBIC-plus ranges from 1 to 7, with higher score meaning worse outcome
5 secondary outcomes
Changes in Montreal Cognitive Assessment (MoCA) score
Time frame: 90±7 days; 180±15 days; 270±20 days
Changes in Mini-mental State Examination (MMSE) score
Time frame: 90±7 days; 180±15 days; 270±20 days
Changes in Barthel index (BI)
Time frame: 90±7 days; 180±15 days; 270±20 days
Changes in Clinician's Interview-Based Impression of Change-plus caregiver input (CIBIC-plus)
Time frame: 90±7 days; 180±15 days; 270±20 days
Severe adverse events
Time frame: Perioperative period
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 25 Mar 2026.
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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.
Department of Neurology, General Hospital of Northern Theater Command
Shenyang, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing deep cervical lymphaticovenous anastomosis in people with Alzheimer Disease, run by General Hospital of Shenyang Military Region at 1 site in China.
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 7 inclusion and 13 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: looking for participants now, as of the sponsor's last update on 25 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Montreal Cognitive Assessment (MoCA) score (time frame: 4±1 days). The study lists 4 primary outcomes in all. 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 25 Mar 2026.