Alzheimers DiseaseNCT07058129
Deep Cervical Lymphatic Venous Anastomosis in the Treatment of Alzheimer's Disease (CLEAN-AD Registry)
An observational study of Alzheimers Disease, run by Beijing Tiantan Hospital at 1 site in China.
Trial summary
This multicenter, prospective registry is to evaluate the efficacy and safety of deep cervical lymphatic venous anastomosis (DC-LVA) in reduing the clinical dementia rating-sum of boxes (CDR-SB) score of Alzheimer's Disease (AD) patients at 12 months after surgery in the real-world. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alzheimers Disease
- What is being tested?
- Deep cervical lymphatic venous anastomosis
- Type of treatment
- Surgery or procedure
- How many people
- 814 participants
- Where
- 1 siteChina
- Study dates
- 30 Jul 2025to 30 Jul 2029
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: AD patients who received DC-LVA treatment
Who may be able to join
- Age ≥ 18 years, male or famale.
- Diagnosed with AD according to the NIA-AA criteria.
- Patients who have received DC-LVA treatment;
- Signed informed consent (by the subject or their relative, and caregiver)
Who cannot join
- Severe neurological deficits in limb movement, language, vision, hearing, or consciousness, or any condition that the investigator determines may prevent the completion of cognitive function assessments.
- The subject lacks a stable and reliable caregiver to accompany with them during entire study follow-up visits.
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
Beijing Tiantan Hopital, Capital Medical University
Beijing
Yijia Guo, 0086-010-59975807, guoyijia_cmu@163.com
About this study
Official title: Deep Cervical Lymphatic Venous Anastomosis in Treatment of Alzheimer's Disease: A Multicenter, Prospective, Registry (CLEAN-AD Registry)
This multicenter, prospective registry is to evaluate the efficacy and safety of deep cervical lymphatic venous anastomosis (DC-LVA) in reduing the clinical dementia rating-sum of boxes (CDR-SB) score of Alzheimer's Disease (AD) patients at 12 months after surgery in the real-world.
Read the detailed description
Alzheimer's Disease (AD) is a common neurodegenerative disorder affecting the elderly population. Global health data estimates that there are 50 million AD patients worldwide, and this number may triple to 150 million cases by 2050. Anti-amyloid β (Aβ) monoclonal antibodies have emerged as disease-modifying therapies for preclinical or mild AD, but the majority of candidate agents have failed to demonstrate clinical efficacy. A series of case studies has suggested the efficacy of deep cervical lymphatic venous anastomosis (DC-LVA) in AD patients, however, there is currently a lack of large-sample cohort study in the real-world.
The primary purpose of this study is to evaluate the efficacy and safety of deep cervical lymphatic venous anastomosis (DC-LVA) in improve the cognitive function of AD patients at 12 months, and to identify subgroups asscociated with the treatment outcome.
This cohort is a multicenter, prospective, registry. A total of 814 patients received DC-LVA treatment in 40 centers from China will be enrolled. Face to face interviews will be made at baseline, 7 days (or hospital discharge), 3 months ± 7 days, 6months ± 15 days, 12 month ± 15 days, 18 month ± 15 days, and 24 month ±15 days.
The change of clinical dementia rating-sum of boxes (CDR-SB) score, Neuropsychiatric Inventory (NPI) score, Activities of Daily Living (ADCS-ADL) score, Caregiver Burden (ZCI-AD) score, Mini-Mental State Examination (MMSE) score, AD Assessment Scale-Cognitive Subscale (ADAS-cog13) score at 3, 6, 12, 18, 24 months, and the change of brain amyloid burden evaluated by Aβ PET-CT centiloid value at 12 months will be measured.
The changes of CDR-SB score will be analyzed using a repeated measures mixed-effects model. Least squares means will be used to estimate the levels at each time point, and the mean difference with 95% confidence intervals will be calculated. Safety outcomes will be summarized using counts/percentages. Adverse events and serious adverse events will be summarized.
In exploratory outcome measures, we will analyse the AD associated biomarkers in lymphatic tissue during the surgery, the change of fluid biomarkers (peripheral blood, saliva, urine,and cerebrospinal fluid AD associated biomarkers), the change of MRI brain volumes (total brain volume, hippocampal volume, lateral ventricle volume), the change of glymphatic function index(DTI-ALPS), the change of MRS metabolic markers (N-Acetylaspartate, Creatine, Choline, Lactate, Glutamate and Glutamine, myo-Inositol), and the change of artificial intelligence-assisted oculomotor/gait measurements during 12 months of follow-up.
- Conditions
- Alzheimers Disease
- Being tested
- Deep cervical lymphatic venous anastomosis
- Keywords
- Alzheimers disease, Cervical lymphatic venous anastomosis, Registry
- 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
Also called lymphatic venous anastomosis
The intervention requires to perform bilateral deep cervical lymphatic venous anastomosis (DC-LVA). Through cervical incision, the deep cervical lymphatic tissue is anatomically dissected and anastomosed with the venous system of the neck. Under indocyanine green (ICG) navigation, the flow of lymphatic fluid into the vein could be observed via ICG tracing fluorescence after surgery.
What is being measured
The primary outcome is the main question the study is designed to answer.
The change of Clinical Dementia Rating-Sum of Boxes score at 12th months after surgery
The change of Clinical Dementia Rating-Sum of Boxes score (CDR-SB, 0-18 score, higher scores mean a worse outcome)
Measured: From baseline to 12th months after surgery
The incidence of perioperative complications within 7 days after surgery
The incidence of perioperative complications
Measured: From baseline to 7th days after surgery
Secondary outcomes (7)
The Change of Clinical Dementia Rating-Sum of Boxes score
Clinical Dementia Rating-Sum of Boxes score (CDR-SB, 0-18 score, higher scores mean a worse outcome)
Measured: From baseline to 3th, 6th, 18th, 24th months after surgery
The Change of Neuropsychiatric Inventory Score
Neuropsychiatric Inventory Score (NPI, 0-144 score, higher scores mean a worse outcome)
Measured: From baseline to 3th, 6th, 12th,18th, 24th months after surgery
The Change of Alzheimer's Disease Assessment Scale-Activity of Daily Living score
Alzheimer's Disease Assessment Scale-Activity of Daily Living score (ADAS-ADL, 0-78 score, higher scores mean a better outcome)
Measured: From baseline to 3th, 6th, 12th, 18th, 24th months after surgery
The Change of Zarit Caregiver Interview of Alzheimer's Disease Score
Zarit Caregiver Interview of Alzheimer's Disease Score (ZCI-AD, 0-88 score, higher scores mean a worse outcome)
Measured: From baseline to 3th, 6th, 12th,18th, 24th months after surgery
The Change of Mini-Mental State Examination Score
Mini-Mental State Examination Score (MMSE, 0-30 score, higher scores mean a better outcome)
Measured: From baseline to 3th, 6th, 12th, 18th, 24th months after surgery
The Change of Alzheimer's Disease Assessment Scale Cognitive Score
Alzheimer's Disease Assessment Scale Cognitive score (ADAS-Cog-13, 0-85 score, higher scores mean a worse outcome)
Measured: From baseline to 3th, 6th, 12th,18th, 24th months after surgery
The Change of Aβ PET-CT Centiloid value
The change of Aβ PET-CT Centiloid value at 12 months
Measured: From baseline to 12th 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 posted10 Jul 2025
- Study start30 Jul 2025 (estimated)
- Primary completion30 Jul 2028 (estimated)
- Study completion30 Jul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimers DiseaseStudies of the same condition, open and under way.
- More trials run by Beijing Tiantan 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 814 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tiantan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, yilong Wang, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07058129
- Sponsor's protocol ID
- KY2025-090-02
- Status last verified
- Jul 2025
- First submitted
- 11 May 2025
- Last updated
- 10 Jul 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 10 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Deep Cervical Lymphatic Venous Anastomosis in Treatment of Alzheimer's Disease: A Multicenter, Prospective, Registry (CLEAN-AD Registry)
- ClinicalTrials.gov ID
- NCT07058129
- Acronym / sponsor ID
- KY2025-090-02
- Conditions
- Alzheimers Disease
- Keywords
- Alzheimers disease, Cervical lymphatic venous anastomosis, Registry
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 814 participants (estimated)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Study start
- 30 Jul 2025 (estimated)
- Primary completion
- 30 Jul 2028 (estimated)
- Study completion
- 30 Jul 2029 (estimated)
- First posted
- 10 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 multicenter, prospective registry is to evaluate the efficacy and safety of deep cervical lymphatic venous anastomosis (DC-LVA) in reduing the clinical dementia rating-sum of boxes (CDR-SB) score of Alzheimer's Disease (AD) patients at 12 months after surgery in the real-world.
Detailed description
Alzheimer's Disease (AD) is a common neurodegenerative disorder affecting the elderly population. Global health data estimates that there are 50 million AD patients worldwide, and this number may triple to 150 million cases by 2050. Anti-amyloid β (Aβ) monoclonal antibodies have emerged as disease-modifying therapies for preclinical or mild AD, but the majority of candidate agents have failed to demonstrate clinical efficacy. A series of case studies has suggested the efficacy of deep cervical lymphatic venous anastomosis (DC-LVA) in AD patients, however, there is currently a lack of large-sample cohort study in the real-world.
The primary purpose of this study is to evaluate the efficacy and safety of deep cervical lymphatic venous anastomosis (DC-LVA) in improve the cognitive function of AD patients at 12 months, and to identify subgroups asscociated with the treatment outcome.
This cohort is a multicenter, prospective, registry. A total of 814 patients received DC-LVA treatment in 40 centers from China will be enrolled. Face to face interviews will be made at baseline, 7 days (or hospital discharge), 3 months ± 7 days, 6months ± 15 days, 12 month ± 15 days, 18 month ± 15 days, and 24 month ±15 days.
The change of clinical dementia rating-sum of boxes (CDR-SB) score, Neuropsychiatric Inventory (NPI) score, Activities of Daily Living (ADCS-ADL) score, Caregiver Burden (ZCI-AD) score, Mini-Mental State Examination (MMSE) score, AD Assessment Scale-Cognitive Subscale (ADAS-cog13) score at 3, 6, 12, 18, 24 months, and the change of brain amyloid burden evaluated by Aβ PET-CT centiloid value at 12 months will be measured.
The changes of CDR-SB score will be analyzed using a repeated measures mixed-effects model. Least squares means will be used to estimate the levels at each time point, and the mean difference with 95% confidence intervals will be calculated. Safety outcomes will be summarized using counts/percentages. Adverse events and serious adverse events will be summarized.
In exploratory outcome measures, we will analyse the AD associated biomarkers in lymphatic tissue during the surgery, the change of fluid biomarkers (peripheral blood, saliva, urine,and cerebrospinal fluid AD associated biomarkers), the change of MRI brain volumes (total brain volume, hippocampal volume, lateral ventricle volume), the change of glymphatic function index(DTI-ALPS), the change of MRS metabolic markers (N-Acetylaspartate, Creatine, Choline, Lactate, Glutamate and Glutamine, myo-Inositol), and the change of artificial intelligence-assisted oculomotor/gait measurements during 12 months of follow-up.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- AD patients who received DC-LVA treatment
Key inclusion criteria (4 listed)
- Age ≥ 18 years, male or famale.
- Diagnosed with AD according to the NIA-AA criteria.
- Patients who have received DC-LVA treatment;
- Signed informed consent (by the subject or their relative, and caregiver)
Key exclusion criteria (2 listed)
- Severe neurological deficits in limb movement, language, vision, hearing, or consciousness, or any condition that the investigator determines may prevent the completion of cognitive function assessments.
- The subject lacks a stable and reliable caregiver to accompany with them during entire study follow-up visits.
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 anastomosisAlso: lymphatic venous anastomosisThe intervention requires to perform bilateral deep cervical lymphatic venous anastomosis (DC-LVA). Through cervical incision, the deep cervical lymphatic tissue is anatomically dissected and anastomosed with the venous system of the neck. Under indocyanine green (ICG) navigation, the flow of lymphatic fluid into the vein could be observed via ICG tracing fluorescence after surgery. | Procedure or surgery | – |
Primary outcome
The change of Clinical Dementia Rating-Sum of Boxes score at 12th months after surgery
Time frame: From baseline to 12th months after surgery
The change of Clinical Dementia Rating-Sum of Boxes score (CDR-SB, 0-18 score, higher scores mean a worse outcome)
The incidence of perioperative complications within 7 days after surgery
Time frame: From baseline to 7th days after surgery
The incidence of perioperative complications
7 secondary outcomes
The Change of Clinical Dementia Rating-Sum of Boxes score
Time frame: From baseline to 3th, 6th, 18th, 24th months after surgery
The Change of Neuropsychiatric Inventory Score
Time frame: From baseline to 3th, 6th, 12th,18th, 24th months after surgery
The Change of Alzheimer's Disease Assessment Scale-Activity of Daily Living score
Time frame: From baseline to 3th, 6th, 12th, 18th, 24th months after surgery
The Change of Zarit Caregiver Interview of Alzheimer's Disease Score
Time frame: From baseline to 3th, 6th, 12th,18th, 24th months after surgery
The Change of Mini-Mental State Examination Score
Time frame: From baseline to 3th, 6th, 12th, 18th, 24th months after surgery
The Change of Alzheimer's Disease Assessment Scale Cognitive Score
Time frame: From baseline to 3th, 6th, 12th,18th, 24th months after surgery
The Change of Aβ PET-CT Centiloid value
Time frame: From baseline to 12th 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 10 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alzheimers Disease, run by Beijing Tiantan 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 4 inclusion and 2 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 10 Jul 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 Yuesong Pan (0086-010-59975807, yuesongpan@aliyun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change of Clinical Dementia Rating-Sum of Boxes score at 12th months after surgery (time frame: From baseline to 12th months after surgery). The study lists 2 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 10 Jul 2025.