Alzheimer s DiseaseDCLVA-ADNCT07669272
Deep Cervical Lymphovenous Anastomosis for Severe Alzheimer's Disease
A study testing Deep Cervical Lymphovenous Anastomosis and Routine Treatment in people with Alzheimer s Disease, run by Southwest Hospital, China at 1 site in China.
Trial summary
Alzheimer's disease (AD) is a severe neurodegenerative disease with heavy social burden. Current drugs cannot reverse disease progression. Brain glymphatic system and meningeal lymphatic dysfunction lead to impaired clearance of Aβ and Tau protein, which is an important pathogenesis of AD. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Alzheimer s Disease
- What is being tested?
- Deep Cervical Lymphovenous Anastomosis and Routine Treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2026to 30 Sep 2029
- 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
- Meet the 2011 NIA-AA clinical diagnostic criteria for probable Alzheimer's disease dementia and the 2018 NIA-AA research framework biomarker criteria for AD.
- Aged 50 to 80 years (inclusive) at the time of signing informed consent.
- Severe cognitive dysfunction: Mini-Mental State Examination (MMSE) score < 10 points.
- Progressive cognitive deterioration for more than 6 months reported by patient or caregiver.
- No clinical improvement after more than 6 months of standardized drug treatment.
- Have a designated study companion who signs informed consent, contacts the patient at least 10 hours per week and accompanies study visits.
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- Able to complete scale assessments and examinations independently or with companion assistance.
- Voluntarily comply with study procedures, examinations and surgical treatment.
- Patient or legal representative can sign written informed consent and abide by trial requirements.
- Patients and families are informed of study purpose, expected efficacy and potential risks, and voluntarily provide biological samples and participate in the study.
Who cannot join
- Severe central nervous system diseases (other than AD) that affect cognitive function or study compliance.
- Severe/unstable systemic diseases (cardiovascular, hepatic, renal, respiratory, endocrine, hematological, psychiatric diseases); life expectancy less than 24 months.
- Surgical contraindications: severe coagulation disorders, severe -cardiopulmonary diseases (myocardial infarction/respiratory failure within recent 30 days); severe liver damage (ALT/AST > 3 times upper limit of normal); severe renal insufficiency (eGFR < 30ml/min).
- Severe primary mental disorders (other than AD) that interfere with efficacy evaluation and cognitive assessment.
- History of intracranial hemorrhage or craniocerebral trauma within recent 1 year.
- Alcohol or drug abuse/dependence within recent 1 year.
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- Allergy to indocyanine green, gadolinium contrast agent, 18F-florbetapir or 18F-flortaucipir.
- Contraindications for PET examination.
- Other conditions judged by investigators unsuitable for enrollment.
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
The First Affiliated Hospital of Army Medical University (Southwest Hospital)
Chongqing, Chongqing Municipality, 400038
Jingyu Chen, MD, +8602368765911, 283686484@qq.com
About this study
Official title: A Single-arm, Prospective, Self-controlled Study on Efficacy and Safety of Deep Cervical Lymphovenous Anastomosis for Neurological Function in Patients With Severe Alzheimer's Disease
Alzheimer's disease (AD) is a severe neurodegenerative disease with heavy social burden. Current drugs cannot reverse disease progression. Brain glymphatic system and meningeal lymphatic dysfunction lead to impaired clearance of Aβ and Tau protein, which is an important pathogenesis of AD. Deep cervical lymphovenous anastomosis (DCLVA) can improve intracranial lymphatic drainage, promote the clearance of toxic proteins, and improve neurological function. This is a single-arm, prospective, self-controlled study to enroll 59 patients with severe AD (MMSE < 10). All patients receive bilateral DCLVA plus routine medication. The primary endpoint is change of CDR-SB score at 12 months post-operation. Secondary endpoints include MMSE, ZBI scores and Aβ PET-CT Centiloid value. This study aims to verify the efficacy and safety of DCLVA for severe AD.
- Conditions
- Alzheimer s Disease
- Being tested
- Deep Cervical Lymphovenous Anastomosis, Routine Treatment
- Keywords
- Alzheimer Disease, Severe Dementia, Cognitive Impairment, Neurodegenerative Disease
- Medical subject headings
- Alzheimer Disease, Dementia, Cognitive Dysfunction, Neurodegenerative Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deep Cervical Lymphovenous AnastomosisProcedure or surgery
A one-time microsurgical procedure performed under general anesthesia. Indocyanine green (ICG) is injected for intraoperative lymphatic vessel tracing under a fluorescent surgical microscope. Lymphatic vessels or lymphatic flaps are anastomosed to cervical veins via end-to-side or end-to-end technique to improve intracranial lymphatic drainage. No additional surgical interventions are applied.
Routine TreatmentOther
Stable administration of standard drugs for Alzheimer's disease, including cholinesterase inhibitors and/or NMDA receptor antagonists, following clinical guidelines. Participants continue their original medication regimen throughout the whole study period without dose adjustment or drug switching.
| Study group | Role | What they receive |
|---|---|---|
| Deep Cervical Lymphovenous Anastomosis plus Routine Treatment | Experimental | All participants receive one-time bilateral deep cervical lymphovenous anastomosis under microsurgery with indocyanine green lymphatic tracing. Conventional anti-Alzheimer's drugs are maintained throughout the study. All outcomes are compared with pre-operation baseline. Receives: Procedure: Deep Cervical Lymphovenous Anastomosis; Other: Routine Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sum of Boxes (CDR-SB) Total Score
The CDR-SB total score ranges from 0 to 18 points. Higher scores indicate more severe cognitive impairment and functional decline. This outcome evaluates the change of total CDR-SB score in patients with severe Alzheimer's disease after receiving deep cervical lymphovenous anastomosis, to assess the therapeutic effect on neurological function.
Measured: Baseline (pre-operation), 12 months after surgery
Secondary outcomes (4)
Sum of Boxes (CDR-SB) Total Score
The CDR-SB total score ranges from 0 to 18 points. Higher scores indicate more severe cognitive impairment and functional decline. This outcome evaluates the change of total CDR-SB score in patients with severe Alzheimer's disease after receiving deep cervical lymphovenous anastomosis, to assess the therapeutic effect on neurological function.
Measured: Baseline (pre-operation), 1 month and 6 months after surgery
Mini-Mental State Examination (MMSE) Score
MMSE total score ranges from 0 to 30. Higher scores represent better cognitive function. A score below 10 indicates severe cognitive impairment. This measure assesses changes in overall cognitive status after surgical intervention.
Measured: Baseline (pre-operation), 1 month, 6 months and 12 months after surgery
Zarit Burden Interview (ZBI) Score
ZBI total score ranges from 0 to 88. Higher scores mean heavier caregiver burden. It is used to evaluate the impact of treatment on the psychological and life burden of patients' caregivers.
Measured: Baseline (pre-operation), 1 month, 6 months and 12 months after surgery
Amyloid-beta (Aβ) PET-CT Centiloid Value
Centiloid value reflects the level of cerebral amyloid-beta deposition. Detect and compare the difference of brain Aβ deposition between baseline and 12 months post-operation.
Measured: Baseline (pre-operation), 12 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2026
- Study start1 Oct 2026 (estimated)
- Primary completion30 Sep 2028 (estimated)
- Study completion30 Sep 2029 (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.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 59 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Southwest Hospital, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rong Hu, MD, Southwest Hospital, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07669272
- Sponsor's protocol ID
- KY2026120
- Other IDs
- (A)KY2024136
- Acronym
- DCLVA-AD
- Status last verified
- Jun 2026
- First submitted
- 21 Jun 2026
- Last updated
- 25 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Individual participant data (IPD) will not be shared externally. All participant data is stored and managed locally in compliance with Chinese medical data privacy regulations and hospital internal management rules.
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-arm, Prospective, Self-controlled Study on Efficacy and Safety of Deep Cervical Lymphovenous Anastomosis for Neurological Function in Patients With Severe Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT07669272
- Acronym / sponsor ID
- DCLVA-AD / KY2026120
- Conditions
- Alzheimer s Disease
- Keywords
- Alzheimer Disease, Severe Dementia, Cognitive Impairment, Neurodegenerative Disease
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 59 participants (estimated)
- Lead sponsor
- Southwest Hospital, ChinaUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 30 Sep 2028 (estimated)
- Study completion
- 30 Sep 2029 (estimated)
- First posted
- 25 Jun 2026 (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.
Alzheimer's disease (AD) is a severe neurodegenerative disease with heavy social burden. Current drugs cannot reverse disease progression. Brain glymphatic system and meningeal lymphatic dysfunction lead to impaired clearance of Aβ and Tau protein, which is an important pathogenesis of AD. Deep cervical lymphovenous anastomosis (DCLVA) can improve intracranial lymphatic drainage, promote the clearance of toxic proteins, and improve neurological function. This is a single-arm, prospective, self-controlled study to enroll 59 patients with severe AD (MMSE < 10). All patients receive bilateral DCLVA plus routine medication. The primary endpoint is change of CDR-SB score at 12 months post-operation. Secondary endpoints include MMSE, ZBI scores and Aβ PET-CT Centiloid value. This study aims to verify the efficacy and safety of DCLVA for severe AD.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Deep Cervical Lymphovenous Anastomosis plus Routine Treatment | Experimental | Procedure: Deep Cervical Lymphovenous Anastomosis, Other: Routine TreatmentAll participants receive one-time bilateral deep cervical lymphovenous anastomosis under microsurgery with indocyanine green lymphatic tracing. Conventional anti-Alzheimer's drugs are maintained throughout the study. All outcomes are compared with pre-operation baseline. |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Meet the 2011 NIA-AA clinical diagnostic criteria for probable Alzheimer's disease dementia and the 2018 NIA-AA research framework biomarker criteria for AD.
- Aged 50 to 80 years (inclusive) at the time of signing informed consent.
- Severe cognitive dysfunction: Mini-Mental State Examination (MMSE) score < 10 points.
- Progressive cognitive deterioration for more than 6 months reported by patient or caregiver.
- No clinical improvement after more than 6 months of standardized drug treatment.
Key exclusion criteria (9 listed)
- Severe central nervous system diseases (other than AD) that affect cognitive function or study compliance.
- Severe/unstable systemic diseases (cardiovascular, hepatic, renal, respiratory, endocrine, hematological, psychiatric diseases); life expectancy less than 24 months.
- Surgical contraindications: severe coagulation disorders, severe -cardiopulmonary diseases (myocardial infarction/respiratory failure within recent 30 days); severe liver damage (ALT/AST > 3 times upper limit of normal); severe renal insufficiency (eGFR < 30ml/min).
- Severe primary mental disorders (other than AD) that interfere with efficacy evaluation and cognitive assessment.
- History of intracranial hemorrhage or craniocerebral trauma within recent 1 year.
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 Lymphovenous AnastomosisA one-time microsurgical procedure performed under general anesthesia. Indocyanine green (ICG) is injected for intraoperative lymphatic vessel tracing under a fluorescent surgical microscope. Lymphatic vessels or lymphatic flaps are anastomosed to cervical veins via end-to-side or end-to-end technique to improve intracranial lymphatic drainage. No additional surgical interventions are applied. | Procedure or surgery | Deep Cervical Lymphovenous Anastomosis plus Routine Treatment |
| Routine TreatmentStable administration of standard drugs for Alzheimer's disease, including cholinesterase inhibitors and/or NMDA receptor antagonists, following clinical guidelines. Participants continue their original medication regimen throughout the whole study period without dose adjustment or drug switching. | Other | Deep Cervical Lymphovenous Anastomosis plus Routine Treatment |
Primary outcome
Sum of Boxes (CDR-SB) Total Score
Time frame: Baseline (pre-operation), 12 months after surgery
The CDR-SB total score ranges from 0 to 18 points. Higher scores indicate more severe cognitive impairment and functional decline. This outcome evaluates the change of total CDR-SB score in patients with severe Alzheimer's disease after receiving deep cervical lymphovenous anastomosis, to assess the therapeutic effect on neurological function.
4 secondary outcomes
Sum of Boxes (CDR-SB) Total Score
Time frame: Baseline (pre-operation), 1 month and 6 months after surgery
Mini-Mental State Examination (MMSE) Score
Time frame: Baseline (pre-operation), 1 month, 6 months and 12 months after surgery
Zarit Burden Interview (ZBI) Score
Time frame: Baseline (pre-operation), 1 month, 6 months and 12 months after surgery
Amyloid-beta (Aβ) PET-CT Centiloid Value
Time frame: Baseline (pre-operation), 12 months after surgery
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 Jun 2026.
- Individual participant dataSharing planned: Undecided. Individual participant data (IPD) will not be shared externally. All participant data is stored and managed locally in compliance with Chinese medical data privacy regulations and hospital internal management rules.
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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.
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 Lymphovenous Anastomosis and Routine Treatment in people with Alzheimer s Disease, run by Southwest Hospital, China 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 10 inclusion and 9 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 25 Jun 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. 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?
Contact Rong Hu, MD (+8602368765911, huchrong@tmmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sum of Boxes (CDR-SB) Total Score (time frame: Baseline (pre-operation), 12 months after surgery). 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 Jun 2026.