AzTrials
AzTrials

Alzheimer s DiseaseNCT07680660

Efficacy of Lymphatic-Venous Anastomosis Plus Donepezil Versus Donepezil Alone for Alzheimer's Disease

A study testing Cervical lymph vessel/node-venous anastomosis surgery combined with oral donepezil and Oral treatment with donepezil in people with Alzheimer s Disease, run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

This study employed a multicenter, randomized controlled trial (RCT) design to evaluate the efficacy and safety of deep cervical lymphatic/lymph node-venous anastomosis combined with oral donepezil compared to donepezil monotherapy in patients with Alzheimer's disease and moderate dementia. 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?
Cervical lymph vessel/node-venous anastomosis surgery combined with oral donepezil and Oral treatment with donepezil
Could I receive a placebo?
No, everyone receives an active treatment
How many people
216 participants
Where
1 siteChina
Study dates
15 Jul 2026to 31 Mar 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

  • The patient or guardian signs the informed consent form;
  • Age 50-80 years (≥50 years, ≤80 years), male or female;
  • The first diagnosis is Alzheimer's disease with dementia;
  • MMSE score ≤24;
  • Positive β-amyloid protein PET imaging findings;
  • HAMD score ≤17;
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  • Hachinski score ≤7;
  • No AD-related drug treatment has been received within the past 1 month;
  • ASA grade 1-3 (≥ grade 1, ≤ grade 3);
  • CDR-SB score of 9.5-15.5.

Who cannot join

  • Presence of contraindications to MRI, ICG angiography, or PET scan;
  • Presence of contraindications to lumbar puncture;
  • Severe heart disease or unstable hemodynamic status;
  • Severe lung disease, including severe obstructive, restrictive, or mixed ventilatory dysfunction, or acute inflammation within 3 months;
  • Hepatic insufficiency, AST or ALT >3 times the upper limit of normal;
  • Renal insufficiency, GFR <60 mL/min or need for blood purification treatment;
Show all 22Show fewer
  • MRI indicates active or acute intracranial lesions, including intracranial infection, space-occupying lesions, major hemorrhage, and ≥4 lobar microbleeds, etc.;
  • History of cerebral hemorrhage or cerebral infarction with severe residual neurological dysfunction;
  • Blood diseases, bleeding/coagulation disorders, coagulation dysfunction;
  • Abnormal thyroid function;
  • Moderate or severe stenosis of intracranial or cervical vessels with severe residual neurological dysfunction;
  • Severe hypertension not effectively controlled, systolic blood pressure ≥180 mmHg or diastolic blood pressure ≥110 mmHg;
  • The disease requires systemic use of steroids;
  • Drug addiction (including alcohol, narcotics, and alcohol dependence);
  • Severe infectious diseases, including HIV positivity, severe infection, etc.;
  • Severe psychiatric disease or potential suicide risk;
  • Within 3 years after radical surgery for malignant tumor;
  • Participation in other interventional clinical trials within the past three months;
  • In the physician's judgment, poor compliance, inability to complete, or unwillingness to cooperate with regular postoperative follow-up;
  • Other circumstances that the physician considers unsuitable for this clinical trial;
  • Anti-Aβ monoclonal antibody treatment has been received within half a year;
  • Previous neck surgery.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Yixin Zhang contact

+86 13061775858

zhangyixin6688@163.com

Ke Li contact

China1 site

  • Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

    Shanghai, Huangpu, 200011

    Yixin Zhang, MD., +86-21-23271699 ext. 5576, shjyiec@126.com

Other trials in China

About this study

Official title: A Multicenter Randomized Controlled Trial on the Efficacy and Safety of Cervical Lymph Vessel/Node-venous Anastomosis Combined With Donepezil Versus Donepezil Alone in the Treatment of Alzheimer's Disease

This study employed a multicenter, randomized controlled trial (RCT) design to evaluate the efficacy and safety of deep cervical lymphatic/lymph node-venous anastomosis combined with oral donepezil compared to donepezil monotherapy in patients with Alzheimer's disease and moderate dementia. Participants were randomized using a central randomization system with stratified block design, with the study center and age group (50-64 years, 65-80 years) as stratification factors. While study participants and surgical investigators could not be blinded due to the nature of the intervention, efficacy assessors and imaging specialists remained blinded to ensure the objectivity and reliability of the findings. The intervention group received deep cervical lymphatic/lymph node-venous anastomosis (detailed surgical procedure is specified in the protocol) in combination with oral donepezil (5-10 mg/day), while the control group received oral donepezil alone. The total treatment and follow-up period was 18 months, with assessments conducted at baseline, 1 week, 1, 3, 6, 12, and 18 months post-operation. These included neuropsychological evaluations (MMSE, MoCA, CDR, BADL, IADL, NPI, AES), neuroimaging (MRI, PET, ultrasound), fluid biomarker analyses (CSF and blood levels of Aβ, Tau, neuroinflammatory factors, etc.), and safety monitoring. The primary efficacy endpoint was the change in CDR-SB score at 12 months post-treatment. Secondary endpoints included changes in multiple cognitive scales, neuroimaging metrics, and biomarkers at 18 months. Safety indicators encompassed adverse event recording, vital signs, and laboratory tests.

Being tested
Cervical lymph vessel/node-venous anastomosis surgery combined with oral donepezil, Oral treatment with donepezil
Keywords
cervical lymph vessel/node-venous anastomosis, LVA, Alzheimer

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cervical lymph vessel/node-venous anastomosis surgery combined with oral donepezilProcedure or surgery

    Under total intravenous anesthesia, the patient is placed supine with the head turned and shoulders elevated. A transverse neck incision is made, the platysma is opened, and the external jugular vein and great auricular nerve are exposed and protected. Dissection proceeds along the sternocleidomastoid muscle and carotid sheath to create two lymphatic composite flaps: a lateral IIB/III flap rich in deep cervical lymph nodes and lymphatic vessels, and a medial IIA flap containing the angular lymph node. Both flaps are prepared to ensure continuous lymphatic fluid outflow. Revascularization is then performed by end-to-end anastomosis of the IIA flap to a branch of the common facial vein or external jugular vein, and end-to-side anastomosis of the IIB/III flap to the internal or external jugular vein. After the anastomosis is completed, the incision is sutured layer by layer for cosmetic purposes.

  • Oral treatment with donepezilDrug

    After randomly assigned into the group, the study participants were given donepezil orally (the cervical lymph vessel/node-venous anastomosis surgery combined with oral donepezil group began to take donepezil orally on the first day after operation, and the oral donepezil group began to take donepezil after completing the baseline examination), once a day, before sleep, starting at 5 mg/day, and adjusted to 10 mg/day after 6 weeks; if not tolerated, it will be maintained at 5 mg/day, continued for 6 weeks, and then 10 mg/day will be attempted again, with continuous administration for 18 months. If research participants still cannot tolerate the high dose, they may be maintained at 5 mg/day for 18 months.

Study groups in NCT07680660
Study groupRoleWhat they receive
Cervical lymph vessel/node-venous anastomosis surgery combined with oral donepezil groupExperimentalNot described
Receives: Procedure: Cervical lymph vessel/node-venous anastomosis surgery combined with oral donepezil; Drug: Oral treatment with donepezil
Oral donepezil groupActive comparatorNot described
Receives: Drug: Oral treatment with donepezil

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change From Baseline in Clinical Dementia Rating-Sum of Boxes Score at Month 12

    The Clinical Dementia Rating-Sum of Boxes is a clinician-rated measure of dementia severity. The score ranges from 0 to 18, with higher scores indicating greater impairment and more severe dementia. The outcome measure is the change from baseline to Month 12. The scale will be administered face to face by trained evaluators blinded to treatment assignment, and results will be reviewed by an independent endpoint adjudication committee.

    Measured: Baseline and Month 12

Secondary outcomes (70)

  1. Change From Baseline in Clinical Dementia Rating-Sum of Boxes Score at Month 18

    The Clinical Dementia Rating-Sum of Boxes score ranges from 0 to 18, with higher scores indicating greater dementia severity. The outcome measure is the change from baseline to Month 18.

    Measured: Baseline and Month 18

  2. Change From Baseline in Mini-Mental State Examination Score at Month 18

    The Mini-Mental State Examination assesses global cognitive function. The score ranges from 0 to 30, with higher scores indicating better cognitive function. The outcome measure is the change from baseline to Month 18.

    Measured: Baseline and Month 18

  3. Change From Baseline in Montreal Cognitive Assessment Score at Month 18

    The Montreal Cognitive Assessment assesses cognitive function. The score ranges from 0 to 30, with higher scores indicating better cognitive function. The outcome measure is the change from baseline to Month 18.

    Measured: Baseline and Month 18

  4. Change From Baseline in 18-item Apathy Evaluation Scale Score at Month 18

    The 18-item Apathy Evaluation Scale assesses apathy symptoms. The total score ranges from 18 to 72, with higher scores indicating more severe apathy. The outcome measure is the change from baseline to Month 18. Assessments will be performed by trained evaluators blinded to treatment assignment.

    Measured: Baseline and Month 18

  5. Change From Baseline in Neuropsychiatric Inventory Total Score at Month 18

    The 12-item Neuropsychiatric Inventory assesses behavioral and psychological symptoms in dementia. For each domain, the domain score is calculated as frequency multiplied by severity. The total score ranges from 0 to 144, with higher scores indicating more severe neuropsychiatric symptoms. The outcome measure is the change from baseline to Month 18.

    Measured: Baseline and Month 18

  6. Change From Baseline in Basic Activities of Daily Living Score at Month 18

    The Basic Activities of Daily Living score is derived from six items of the Activities of Daily Living scale, including walking, eating, dressing, grooming, bathing, and toileting. Each item is scored from 1 to 4, and the total score ranges from 6 to 24, with higher scores indicating greater impairment in basic self-care ability. The outcome measure is the change from baseline to Month 18.

    Measured: Baseline and Month 18

  7. Change From Baseline in Instrumental Activities of Daily Living Score at Month 18

    The Instrumental Activities of Daily Living score is derived from eight items of the Activities of Daily Living scale, including using public transportation, cooking, doing housework, taking medication, doing laundry, shopping, using the telephone, and handling personal finances. Each item is scored from 1 to 4, and the total score ranges from 8 to 32, with higher scores indicating greater impairment in complex daily living ability. The outcome measure is the change from baseline to Month 18.

    Measured: Baseline and Month 18

  8. Change From Baseline in PET Imaging Measures at Month 18

    Positron emission tomography (PET) will be used to assess cerebral amyloid and tau burden:

    Amyloid PET: Cerebral amyloid deposition will be quantified using the unitless standardized uptake value ratio (SUVR) and the standardized Centiloid scale. Higher SUVR and Centiloid values indicate greater amyloid deposition.

    Tau PET: Cerebral tau deposition will be quantified using the unitless standardized uptake value ratio (SUVR). Higher SUVR values indicate greater tau deposition.

    Measured: Baseline and Month 18

  9. Change From Baseline in Brain Volumetric MRI Measures at Month 18

    Structural brain MRI will be used to measure gray matter volume (GMV), white matter volume (WMV), cerebrospinal fluid volume (CSFV), intracranial volume (ICV), white matter hyperintensity volume (WMHV), hippocampal volume (HippV), and frontal lobe volume (FronV). All volumes will be reported in milliliters (mL). The outcome measures are the changes in these MRI-derived volumes from baseline to Month 18.

    Measured: Baseline and Month 18

  10. Change From Baseline in Glymphatic System-Related MRI Measures at Month 18

    MRI will be used to assess glymphatic system-related measures: perivascular space volume fraction in the whole brain, white matter, and basal ganglia (PVSVF-ALL, PVSVF-WM, and PVSVF-BG); free-water fraction in the whole brain, white matter, and basal ganglia (FW-ALL, FW-WM, and FW-BG); and diffusion tensor imaging analysis along the perivascular space indices for the left hemisphere, right hemisphere, and overall brain (ALPS-L, ALPS-R, and ALPS-ALL). PVSVF and FW are reported as unitless numerical fractions, and the ALPS indices are dimensionless. The outcome measures are the changes in these MRI-derived values from baseline to Month 18.

    Measured: Baseline and Month 18

  11. Change From Baseline in Internal Jugular Vein Diameter on Ultrasound at Month 18

    Ultrasound will be used to measure the diameter of the internal jugular vein in the operative area. The diameter will be reported in millimeters. The outcome measure is the change from baseline to Month 18.

    Measured: Baseline and Month 18

  12. Change From Baseline in External Jugular Vein Diameter on Ultrasound at Month 18

    Ultrasound will be used to measure the diameter of the external jugular vein in the operative area. The diameter will be reported in millimeters. The outcome measure is the change from baseline to Month 18.

    Measured: Baseline and Month 18

  13. Change From Baseline in Maximum Jugular Vein Flow Velocity on Ultrasound at Month 18

    Ultrasound will be used to measure the maximum flow velocity of the internal or external jugular vein in the operative area. Flow velocity will be reported in centimeters per second. The outcome measure is the change from baseline to Month 18.

    Measured: Baseline and Month 18

  14. Histopathological Findings in Intraoperatively Collected Lymph Node Tissue

    Histopathological findings in lymph node tissue collected intraoperatively, when available, will be assessed using routine histopathological staining.

    Measured: During surgery

  15. Concentration of Phosphorylated Tau 217 in Intraoperatively Collected Lymphatic Fluid

    The concentration of phosphorylated tau 217 (P-tau217) in lymphatic fluid collected intraoperatively, when available, will be measured (pg/mL).

    Measured: During surgery

  16. Concentration of Amyloid-Beta 42 in Intraoperatively Collected Lymphatic Fluid

    The concentration of amyloid-beta 42 (Aβ42) in lymphatic fluid collected intraoperatively, when available, will be measured (pg/mL).

    Measured: During surgery

  17. Concentration of Phosphorylated Tau 181 in Intraoperatively Collected Lymphatic Fluid

    The concentration of phosphorylated tau 181 (P-tau181) in lymphatic fluid collected intraoperatively, when available, will be measured （pg/ml).

    Measured: During surgery

  18. Concentration of Amyloid-Beta 40 in Intraoperatively Collected Lymphatic Fluid

    The concentration of amyloid-beta 40 (Aβ40) in lymphatic fluid collected intraoperatively, when available, will be measured (pg/mL).

    Measured: During surgery

  19. Concentration of Neurofilament Light Chain in Intraoperatively Collected Lymphatic Fluid

    The concentration of neurofilament light chain (NfL) in lymphatic fluid collected intraoperatively, when available, will be measured (pg/mL).

    Measured: During surgery

  20. Concentration of Glial Fibrillary Acidic Protein in Intraoperatively Collected Lymphatic Fluid

    The concentration of glial fibrillary acidic protein (GFAP) in lymphatic fluid collected intraoperatively, when available, will be measured (pg/mL).

    Measured: During surgery

  21. Concentration of Interleukin-1 Beta in Intraoperatively Collected Lymphatic Fluid

    The concentration of interleukin-1 beta (IL-1β) in lymphatic fluid collected intraoperatively, when available, will be measured (pg/mL).

    Measured: During surgery

  22. Concentration of Interleukin-2 in Intraoperatively Collected Lymphatic Fluid

    The concentration of interleukin-2 (IL-2) in lymphatic fluid collected intraoperatively, when available, will be measured (pg/mL).

    Measured: During surgery

  23. Concentration of Interleukin-8 in Intraoperatively Collected Lymphatic Fluid

    The concentration of interleukin-8 (IL-8) in lymphatic fluid collected intraoperatively, when available, will be measured (pg/mL).

    Measured: During surgery

  24. Concentration of Tumor Necrosis Factor Alpha in Intraoperatively Collected Lymphatic Fluid

    The concentration of tumor necrosis factor alpha (TNF-α) in lymphatic fluid collected intraoperatively, when available, will be measured (pg/mL).

    Measured: During surgery

  25. Concentration of Interleukin-12 p70 in Intraoperatively Collected Lymphatic Fluid

    The concentration of interleukin-12 p70 (IL-12p70) in lymphatic fluid collected intraoperatively, when available, will be measured (pg/mL).

    Measured: During surgery

  26. Concentration of Interleukin-6 in Intraoperatively Collected Lymphatic Fluid

    The concentration of interleukin-6 (IL-6) in lymphatic fluid collected intraoperatively, when available, will be measured (pg/mL).

    Measured: During surgery

  27. Concentration of Interferon Gamma in Intraoperatively Collected Lymphatic Fluid

    The concentration of interferon gamma (IFN-γ) in lymphatic fluid collected intraoperatively, when available, will be measured (pg/mL).

    Measured: During surgery

  28. Concentration of Interleukin-17 in Intraoperatively Collected Lymphatic Fluid

    The concentration of interleukin-17 (IL-17) in lymphatic fluid collected intraoperatively, when available, will be measured (pg/mL).

    Measured: During surgery

  29. Concentration of Interleukin-4 in Intraoperatively Collected Lymphatic Fluid

    The concentration of interleukin-4 (IL-4) in lymphatic fluid collected intraoperatively, when available, will be measured (pg/mL).

    Measured: During surgery

  30. Concentration of Interleukin-10 in Intraoperatively Collected Lymphatic Fluid

    The concentration of interleukin-10 (IL-10) in lymphatic fluid collected intraoperatively, when available, will be measured (pg/mL).

    Measured: During surgery

  31. Concentration of Interleukin-5 in Intraoperatively Collected Lymphatic Fluid

    The concentration of interleukin-5 (IL-5) in lymphatic fluid collected intraoperatively, when available, will be measured (pg/mL).

    Measured: During surgery

  32. Concentration of Interferon Alpha in Intraoperatively Collected Lymphatic Fluid

    The concentration of interferon alpha (IFN-α) in lymphatic fluid collected intraoperatively, when available, will be measured (pg/mL).

    Measured: During surgery

  33. Change From Baseline in Cerebrospinal Fluid P-tau181 Level at Month 18

    The concentration of phosphorylated tau 181 (P-tau181) in cerebrospinal fluid will be measured in picograms per milliliter (pg/mL). The outcome measure is the change from baseline to Month 18.

    Measured: Baseline and Month 18

  34. Change From Baseline in Cerebrospinal Fluid Aβ42 Level at Month 18

    The concentration of amyloid-beta 42 (Aβ42) in cerebrospinal fluid will be measured in picograms per milliliter (pg/mL). The outcome measure is the change from baseline to Month 18.

    Measured: Baseline and Month 18

  35. Change From Baseline in Cerebrospinal Fluid Aβ40 Level at Month 18

    The concentration of amyloid-beta 40 (Aβ40) in cerebrospinal fluid will be measured in picograms per milliliter (pg/mL). The outcome measure is the change from baseline to Month 18.

    Measured: Baseline and Month 18

  36. Change From Baseline in Cerebrospinal Fluid Aβ42/Aβ40 Ratio at Month 18

    The ratio of amyloid-beta 42 to amyloid-beta 40 (Aβ42/Aβ40) in cerebrospinal fluid will be reported as a unitless ratio. The outcome measure is the change from baseline to Month 18.

    Measured: Baseline and Month 18

  37. Change From Baseline in Cerebrospinal Fluid GFAP Level at Month 18

    The concentration of glial fibrillary acidic protein (GFAP) in cerebrospinal fluid will be measured in picograms per milliliter (pg/mL). The outcome measure is the change from baseline to Month 18.

    Measured: Baseline and Month 18

  38. Change From Baseline in Cerebrospinal Fluid NfL Level at Month 18

    The concentration of neurofilament light chain (NfL) in cerebrospinal fluid will be measured in picograms per milliliter (pg/mL). The outcome measure is the change from baseline to Month 18.

    Measured: Baseline and Month 18

  39. Change From Baseline in Cerebrospinal Fluid pTau217 Level at Month 18

    The concentration of phosphorylated tau 217 (pTau217) in cerebrospinal fluid will be measured in picograms per milliliter (pg/mL). The outcome measure is the change from baseline to Month 18.

    Measured: Baseline and Month 18

  40. Change From Baseline in Cerebrospinal Fluid IL-1β Level at Month 18

    The concentration of interleukin-1 beta (IL-1β) in cerebrospinal fluid will be measured in picograms per milliliter (pg/mL). The outcome measure is the change from baseline to Month 18.

    Measured: Baseline and Month 18

  41. Change From Baseline in Cerebrospinal Fluid IL-2 Level at Month 18

    The concentration of interleukin-2 (IL-2) in cerebrospinal fluid will be measured in picograms per milliliter (pg/mL). The outcome measure is the change from baseline to Month 18.

    Measured: Baseline and Month 18

  42. Change From Baseline in Cerebrospinal Fluid IL-8 Level at Month 18

    The concentration of interleukin-8 (IL-8) in cerebrospinal fluid will be measured in picograms per milliliter (pg/mL). The outcome measure is the change from baseline to Month 18.

    Measured: Baseline and Month 18

  43. Change From Baseline in Cerebrospinal Fluid TNF-α Level at Month 18

    The concentration of tumor necrosis factor alpha (TNF-α) in cerebrospinal fluid will be measured in picograms per milliliter (pg/mL). The outcome measure is the change from baseline to Month 18.

    Measured: Baseline and Month 18

  44. Change From Baseline in Cerebrospinal Fluid IL-12p70 Level at Month 18

    The concentration of interleukin-12 p70 (IL-12p70) in cerebrospinal fluid will be measured in picograms per milliliter (pg/mL). The outcome measure is the change from baseline to Month 18.

    Measured: Baseline and Month 18

  45. Change From Baseline in Cerebrospinal Fluid IL-6 Level at Month 18

    The concentration of interleukin-6 (IL-6) in cerebrospinal fluid will be measured in picograms per milliliter (pg/mL). The outcome measure is the change from baseline to Month 18.

    Measured: Baseline and Month 18

  46. Change From Baseline in Cerebrospinal Fluid IFN-γ Level at Month 18

    The concentration of interferon gamma (IFN-γ) in cerebrospinal fluid will be measured in picograms per milliliter (pg/mL). The outcome measure is the change from baseline to Month 18.

    Measured: Baseline and Month 18

  47. Change From Baseline in Cerebrospinal Fluid IL-17 Level at Month 18

    The concentration of interleukin-17 (IL-17) in cerebrospinal fluid will be measured in picograms per milliliter (pg/mL). The outcome measure is the change from baseline to Month 18.

    Measured: Baseline and Month 18

  48. Change From Baseline in Cerebrospinal Fluid IL-4 Level at Month 18

    The concentration of interleukin-4 (IL-4) in cerebrospinal fluid will be measured in picograms per milliliter (pg/mL). The outcome measure is the change from baseline to Month 18.

    Measured: Baseline and Month 18

  49. Change From Baseline in Cerebrospinal Fluid IL-10 Level at Month 18

    The concentration of interleukin-10 (IL-10) in cerebrospinal fluid will be measured in picograms per milliliter (pg/mL). The outcome measure is the change from baseline to Month 18.

    Measured: Baseline and Month 18

  50. Change From Baseline in Cerebrospinal Fluid IL-5 Level at Month 18

    The concentration of interleukin-5 (IL-5) in cerebrospinal fluid will be measured in picograms per milliliter (pg/mL). The outcome measure is the change from baseline to Month 18.

    Measured: Baseline and Month 18

  51. Change From Baseline in Cerebrospinal Fluid Interferon Alpha Level at Month 18

    The concentration of interferon alpha (IFN-α) in cerebrospinal fluid will be measured in picograms per milliliter (pg/mL). The outcome measure is the change from baseline to Month 18.

    Measured: Baseline and Month 18

  52. Change From Baseline in Plasma P-tau181 Level at Month 18

    The concentration of phosphorylated tau 181 (P-tau181) in plasma will be measured in picograms per milliliter (pg/mL). The outcome measure is the change from baseline to Month 18.

    Measured: Baseline and Month 18

  53. Change From Baseline in Plasma Aβ42 Level at Month 18

    The concentration of amyloid-beta 42 (Aβ42) in plasma will be measured in picograms per milliliter (pg/mL). The outcome measure is the change from baseline to Month 18.

    Measured: Baseline and Month 18

  54. Change From Baseline in Plasma Aβ40 Level at Month 18

    The concentration of amyloid-beta 40 (Aβ40) in plasma will be measured in picograms per milliliter (pg/mL). The outcome measure is the change from baseline to Month 18.

    Measured: Baseline and Month 18

  55. Change From Baseline in Plasma Aβ42/Aβ40 Ratio at Month 18

    The ratio of amyloid-beta 42 to amyloid-beta 40 (Aβ42/Aβ40) in plasma will be reported as a unitless ratio. The outcome measure is the change from baseline to Month 18.

    Measured: Baseline and Month 18

  56. Change From Baseline in Plasma GFAP Level at Month 18

    The concentration of glial fibrillary acidic protein (GFAP) in plasma will be measured in picograms per milliliter (pg/mL). The outcome measure is the change from baseline to Month 18.

    Measured: Baseline and Month 18

  57. Change From Baseline in Plasma NfL Level at Month 18

    The concentration of neurofilament light chain (NfL) in plasma will be measured in picograms per milliliter (pg/mL). The outcome measure is the change from baseline to Month 18.

    Measured: Baseline and Month 18

  58. Change From Baseline in Plasma pTau217 Level at Month 18

    The concentration of phosphorylated tau 217 (pTau217) in plasma will be measured in picograms per milliliter (pg/mL). The outcome measure is the change from baseline to Month 18.

    Measured: Baseline and Month 18

  59. Change From Baseline in Plasma IL-1β Level at Month 18

    The concentration of interleukin-1 beta (IL-1β) in plasma will be measured in picograms per milliliter (pg/mL). The outcome measure is the change from baseline to Month 18.

    Measured: Baseline and Month 18

  60. Change From Baseline in Plasma IL-2 Level at Month 18

    The concentration of interleukin-2 (IL-2) in plasma will be measured in picograms per milliliter (pg/mL). The outcome measure is the change from baseline to Month 18.

    Measured: Baseline and Month 18

  61. Change From Baseline in Plasma IL-8 Level at Month 18

    The concentration of interleukin-8 (IL-8) in plasma will be measured in picograms per milliliter (pg/mL). The outcome measure is the change from baseline to Month 18.

    Measured: Baseline and Month 18

  62. Change From Baseline in Plasma TNF-α Level at Month 18

    The concentration of tumor necrosis factor alpha (TNF-α) in plasma will be measured in picograms per milliliter (pg/mL). The outcome measure is the change from baseline to Month 18.

    Measured: Baseline and Month 18

  63. Change From Baseline in Plasma IL-12p70 Level at Month 18

    The concentration of interleukin-12 p70 (IL-12p70) in plasma will be measured in picograms per milliliter (pg/mL). The outcome measure is the change from baseline to Month 18.

    Measured: Baseline and Month 18

  64. Change From Baseline in Plasma IL-6 Level at Month 18

    The concentration of interleukin-6 (IL-6) in plasma will be measured in picograms per milliliter (pg/mL). The outcome measure is the change from baseline to Month 18.

    Measured: Baseline and Month 18

  65. Change From Baseline in Plasma IFN-γ Level at Month 18

    The concentration of interferon gamma (IFN-γ) in plasma will be measured in picograms per milliliter (pg/mL). The outcome measure is the change from baseline to Month 18.

    Measured: Baseline and Month 18

  66. Change From Baseline in Plasma IL-17 Level at Month 18

    The concentration of interleukin-17 (IL-17) in plasma will be measured in picograms per milliliter (pg/mL). The outcome measure is the change from baseline to Month 18.

    Measured: Baseline and Month 18

  67. Change From Baseline in Plasma IL-4 Level at Month 18

    The concentration of interleukin-4 (IL-4) in plasma will be measured in picograms per milliliter (pg/mL). The outcome measure is the change from baseline to Month 18.

    Measured: Baseline and Month 18

  68. Change From Baseline in Plasma IL-10 Level at Month 18

    The concentration of interleukin-10 (IL-10) in plasma will be measured in picograms per milliliter (pg/mL). The outcome measure is the change from baseline to Month 18.

    Measured: Baseline and Month 18

  69. Change From Baseline in Plasma IL-5 Level at Month 18

    The concentration of interleukin-5 (IL-5) in plasma will be measured in picograms per milliliter (pg/mL). The outcome measure is the change from baseline to Month 18.

    Measured: Baseline and Month 18

  70. Change From Baseline in Plasma Interferon Alpha Level at Month 18

    The concentration of interferon alpha (IFN-α) in plasma will be measured in picograms per milliliter (pg/mL). The outcome measure is the change from baseline to Month 18.

    Measured: Baseline and Month 18

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Jul 2026
  2. Study start15 Jul 2026 (estimated)
  3. Primary completion30 Sep 2028 (estimated)
  4. Study completion31 Mar 2029 (estimated)

Resources

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
Single blind
Who is masked
Outcomes assessor
Enrolment
216 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07680660
Sponsor's protocol ID
SH9H-2025-T549
Status last verified
Mar 2026
First submitted
7 Jun 2026
Last updated
22 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

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  • 卢鸿瑞,谭云飞,谢庆平. 3D脱目镜下行颈深淋巴管-静脉引流术治疗老年认知障碍患者一例疗效初步观察. 中华显微外科杂志,2022,45(5):570-574.

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Questions about this trial

What is this clinical trial studying?

A study testing Cervical lymph vessel/node-venous anastomosis surgery combined with oral donepezil and Oral treatment with donepezil in people with Alzheimer s Disease, run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University 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 22 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 22 Jul 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 Yixin Zhang (+86 13061775858, zhangyixin6688@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Clinical Dementia Rating-Sum of Boxes Score at Month 12 (time frame: Baseline and Month 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07680660, which also lists 17 linked publications.

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 22 Jul 2026.

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