Alzheimer DiseaseNCT06978946
Deep Cervical Lymphaticovenous Anastomosis Surgery for Moderate-to-Advanced Dementia Patients
A study testing Deep Cervical Lymphaticovenous Anastomosis(DLVA) in people with Alzheimer Disease and Lewy Body Dementia (LBD), run by RenJi Hospital at 1 site in China.
Trial summary
This clinical trial aims to evaluate the clinical efficacy and safety of Deep Cervical Lymphaticovenous Anastomosis (DLVA) in patients aged 50-80 with moderate to severe neurodegenerative dementia. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Alzheimer Disease, Lewy Body Dementia (LBD), Frontotemporal Dementia (FTD)
- What is being tested?
- Deep Cervical Lymphaticovenous Anastomosis(DLVA)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 1 siteChina
- Study dates
- 28 May 2025to 28 Feb 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 between 50-80 years
- AD participants meet the diagnostic criteria for Alzheimer's disease established by the National Institute on Aging and the Alzheimer's Association (NIA-AA); FTD participants meet the diagnostic criteria defined by the International Consortium on FTD; DLB participants meet the 2017 diagnostic criteria of the DLB Consortium; PDD participants meet the 2007 diagnostic criteria of the Movement Disorder Society or the 2011 Chinese diagnostic guidelines for PDD;
- Mini-Mental State Examination (MMSE)<than 21, Montreal Cognitive Assessment (MoCA) score<17, and Clinical Dementia Rating (CDR) score ≥2;
- Diagnosed by clinicians as having moderate to severe disease;
- On stable medication regimen for ≥1 month
- Signed informed consent and demonstrated good compliance
Who cannot join
- Dementia caused by other conditions, including: vascular dementia; central nervous system infections due to HIV, syphilis, etc.; Creutzfeldt-Jakob disease; Huntington's disease; traumatic brain injury-related dementia; dementia due to toxic or alcohol-related factors; major systemic diseases such as hepatic or pulmonary encephalopathy; subdural hematoma; endocrine disorders such as thyroid or parathyroid disease; vitamin deficiency; or any other cause of dementia.
- Presence of severe or unstable medical conditions, including but not limited to cardiovascular, hepatic, renal, gastrointestinal, respiratory, endocrine, neurological (excluding cognitive impairment), psychiatric, immunological, or hematological disorders, or any other condition deemed by the investigator to potentially interfere with study results; or life expectancy < 24 months.
- Current diagnosis of any primary psychiatric disorder other than cognitive impairment. If, in the investigator's opinion, the psychiatric condition or symptoms may interfere with cognitive assessment or the subject's ability to complete the study, exclusion is required. Subjects with a history of schizophrenia or other chronic psychotic disorders should also be excluded.
- Contraindications to deep cervical LVA surgery, including left vagus nerve injury, severe infection at the surgical site, significant dysfunction of the heart, lungs, liver, kidneys, or other organ systems, a history of head and neck radiation therapy or surgery, preoperative anesthetic evaluation of ASA grade III or above, or inability to tolerate prolonged surgery.
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
Renji Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200217
Nan Zhi, MD, ＋86 18616878901, zhinan@renji.com
About this study
Official title: Clinical Efficacy and Safety of Deep Cervical Lymphaticovenous Anastomosis (DLVA) in Moderate-to-Severe Neurodegenerative Dementia
This clinical trial aims to evaluate the clinical efficacy and safety of Deep Cervical Lymphaticovenous Anastomosis (DLVA) in patients aged 50-80 with moderate to severe neurodegenerative dementia. Participants will undergo surgical treatment, followed by cognitive assessments, PET/MRI scans, lymph fluid/cerebrospinal fluid collection, and blood tests. Additionally, the study will perform an in-depth analysis of DLVA's therapeutic mechanisms using multimodal imaging and molecular biology experiments.
- Conditions
- Alzheimer Disease, Lewy Body Dementia (LBD), Frontotemporal Dementia (FTD), Dementia, Parkinsons Disease With Dementia (PDD)
- Being tested
- Deep Cervical Lymphaticovenous Anastomosis(DLVA)
- Keywords
- Alzheimer Diseas, Lewy Body Dementia (LBD), Frontotemporal Dementia (FTD), Lymphaticovenous Anastomosis, Parkinsons Disease
- Medical subject headings
- Alzheimer Disease, Lewy Body Disease, Frontotemporal Dementia, Dementia, Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deep Cervical Lymphaticovenous Anastomosis(DLVA)Procedure or surgery
This surgery will enhance the drainage of cerebral lymphatic fluid by surgically establishing a connection between lymphatic vessels and veins in the neck
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | This group served as the control group, consisting of AD patients who received no intervention. |
| PDD surgical intervention group | Experimental | Participants in this group will undergo the Deep Cervical Lymphaticovenous Anastomosis (DLVA) surgery. Receives: Procedure: Deep Cervical Lymphaticovenous Anastomosis(DLVA) |
| DLB surgical intervention group | Experimental | Participants in this group will undergo the Deep Cervical Lymphaticovenous Anastomosis (DLVA) surgery. Receives: Procedure: Deep Cervical Lymphaticovenous Anastomosis(DLVA) |
| FTD surgical intervention group | Experimental | Participants in this group will undergo the Deep Cervical Lymphaticovenous Anastomosis (DLVA) surgery. Receives: Procedure: Deep Cervical Lymphaticovenous Anastomosis(DLVA) |
| AD surgical intervention group | Experimental | Participants in this group will undergo the Deep Cervical Lymphaticovenous Anastomosis (DLVA) surgery. Receives: Procedure: Deep Cervical Lymphaticovenous Anastomosis(DLVA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Severity of dementia
Measured using the (Clinical Dementia Rating Scale - Sum of Boxes(CDR-SB).The CDR-SB is a quantitative tool used to assess the severity of cognitive and functional impairment across six domains: memory, orientation, judgment and problem solving, community affairs, home and hobbies, and personal care. Each domain is rated on a scale from 0 (no impairment) to 3 (severe impairment), resulting in a total CDR-SB score ranging from 0 to 18. A score of 0 indicates no dementia, scores between 0.5 and 4.0 suggest very mild cognitive impairment or mild cognitive decline, 4.5 to 9.0 corresponds to mild dementia, 9.5 to 15.5 reflects moderate dementia, and scores between 16 and 18 represent severe dementia. In general, higher CDR-SB scores reflect greater cognitive and functional impairment, while lower scores indicate better cognitive performance and daily functioning.
Measured: preoperative day 3，postoperative day 3、month 3、month 6、month12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2025
- Study start28 May 2025 (estimated)
- Primary completion1 Feb 2027 (estimated)
- Study completion28 Feb 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.
- More trials run by RenJi HospitalThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 85 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wang Gang, RenJi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06978946
- Sponsor's protocol ID
- DLVA-NDD-01
- Status last verified
- May 2025
- First submitted
- 11 May 2025
- Last updated
- 28 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 28 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Efficacy and Safety of Deep Cervical Lymphaticovenous Anastomosis (DLVA) in Moderate-to-Severe Neurodegenerative Dementia
- ClinicalTrials.gov ID
- NCT06978946
- Acronym / sponsor ID
- DLVA-NDD-01
- Conditions
- Alzheimer Disease, Lewy Body Dementia (LBD), Frontotemporal Dementia (FTD), Dementia, Parkinsons Disease With Dementia (PDD)
- Keywords
- Alzheimer Diseas, Lewy Body Dementia (LBD), Frontotemporal Dementia (FTD), Lymphaticovenous Anastomosis, Parkinsons Disease
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 85 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Study start
- 28 May 2025 (estimated)
- Primary completion
- 1 Feb 2027 (estimated)
- Study completion
- 28 Feb 2027 (estimated)
- First posted
- 18 May 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 clinical trial aims to evaluate the clinical efficacy and safety of Deep Cervical Lymphaticovenous Anastomosis (DLVA) in patients aged 50-80 with moderate to severe neurodegenerative dementia. Participants will undergo surgical treatment, followed by cognitive assessments, PET/MRI scans, lymph fluid/cerebrospinal fluid collection, and blood tests. Additionally, the study will perform an in-depth analysis of DLVA's therapeutic mechanisms using multimodal imaging and molecular biology experiments.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –This group served as the control group, consisting of AD patients who received no intervention. |
| PDD surgical intervention group | Experimental | Procedure: Deep Cervical Lymphaticovenous Anastomosis(DLVA)Participants in this group will undergo the Deep Cervical Lymphaticovenous Anastomosis (DLVA) surgery. |
| DLB surgical intervention group | Experimental | Procedure: Deep Cervical Lymphaticovenous Anastomosis(DLVA)Participants in this group will undergo the Deep Cervical Lymphaticovenous Anastomosis (DLVA) surgery. |
| FTD surgical intervention group | Experimental | Procedure: Deep Cervical Lymphaticovenous Anastomosis(DLVA)Participants in this group will undergo the Deep Cervical Lymphaticovenous Anastomosis (DLVA) surgery. |
| AD surgical intervention group | Experimental | Procedure: Deep Cervical Lymphaticovenous Anastomosis(DLVA)Participants in this group will undergo the Deep Cervical Lymphaticovenous Anastomosis (DLVA) surgery. |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age between 50-80 years
- AD participants meet the diagnostic criteria for Alzheimer's disease established by the National Institute on Aging and the Alzheimer's Association (NIA-AA); FTD participants meet the diagnostic criteria defined by the International Consortium on FTD; DLB participants meet the 2017 diagnostic criteria of the DLB Consortium; PDD participants meet the 2007 diagnostic criteria of the Movement Disorder Society or the 2011 Chinese diagnostic guidelines for PDD;
- Mini-Mental State Examination (MMSE)<than 21, Montreal Cognitive Assessment (MoCA) score<17, and Clinical Dementia Rating (CDR) score ≥2;
- Diagnosed by clinicians as having moderate to severe disease;
- On stable medication regimen for ≥1 month
Key exclusion criteria (4 listed)
- Dementia caused by other conditions, including: vascular dementia; central nervous system infections due to HIV, syphilis, etc.; Creutzfeldt-Jakob disease; Huntington's disease; traumatic brain injury-related dementia; dementia due to toxic or alcohol-related factors; major systemic diseases such as hepatic or pulmonary encephalopathy; subdural hematoma; endocrine disorders such as thyroid or parathyroid disease; vitamin deficiency; or any other cause of dementia.
- Presence of severe or unstable medical conditions, including but not limited to cardiovascular, hepatic, renal, gastrointestinal, respiratory, endocrine, neurological (excluding cognitive impairment), psychiatric, immunological, or hematological disorders, or any other condition deemed by the investigator to potentially interfere with study results; or life expectancy < 24 months.
- Current diagnosis of any primary psychiatric disorder other than cognitive impairment. If, in the investigator's opinion, the psychiatric condition or symptoms may interfere with cognitive assessment or the subject's ability to complete the study, exclusion is required. Subjects with a history of schizophrenia or other chronic psychotic disorders should also be excluded.
- Contraindications to deep cervical LVA surgery, including left vagus nerve injury, severe infection at the surgical site, significant dysfunction of the heart, lungs, liver, kidneys, or other organ systems, a history of head and neck radiation therapy or surgery, preoperative anesthetic evaluation of ASA grade III or above, or inability to tolerate prolonged surgery.
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 Anastomosis(DLVA)This surgery will enhance the drainage of cerebral lymphatic fluid by surgically establishing a connection between lymphatic vessels and veins in the neck | Procedure or surgery | AD surgical intervention group, DLB surgical intervention group, FTD surgical intervention group, PDD surgical intervention group |
Primary outcome
Severity of dementia
Time frame: preoperative day 3，postoperative day 3、month 3、month 6、month12
Measured using the (Clinical Dementia Rating Scale - Sum of Boxes(CDR-SB).The CDR-SB is a quantitative tool used to assess the severity of cognitive and functional impairment across six domains: memory, orientation, judgment and problem solving, community affairs, home and hobbies, and personal care. Each domain is rated on a scale from 0 (no impairment) to 3 (severe impairment), resulting in a total CDR-SB score ranging from 0 to 18. A score of 0 indicates no dementia, scores between 0.5 and 4.0 suggest very mild cognitive impairment or mild cognitive decline, 4.5 to 9.0 corresponds to mild dementia, 9.5 to 15.5 reflects moderate dementia, and scores between 16 and 18 represent severe dementia. In general, higher CDR-SB scores reflect greater cognitive and functional impairment, while lower scores indicate better cognitive performance and daily functioning.
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 28 May 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.
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(DLVA) in people with Alzheimer Disease and Lewy Body Dementia (LBD), run by RenJi Hospital 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 6 inclusion and 4 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 28 May 2025. 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 Nan Zhi (＋86 18616878901, zhinan@renji.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Severity of dementia (time frame: preoperative day 3，postoperative day 3、month 3、month 6、month12). 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 28 May 2025.