An interventional study of Cervical lymph vessel/node-venous anastomosis surgery combined with oral donepezil and Oral treatment with donepezil in Alzheimer s Disease, sponsored by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University. Not yet recruiting at 1 site in China. Open to participants aged 50 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-07-22.
Sponsored by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University · Not applicable, Interventional, and Treatment
Help build ClinicalTrials.gg — short surveys, remote interviews or testing, in your language. Take part →
Among 260 studies in Alzheimer Disease with a site in China — 150 open to participants now, 162 under way, 21 of them phase 3. Alzheimer Disease · China.
Among the 260 studies in Alzheimer Disease with a site in China, this one is the 52nd largest by planned enrollment of the 176 interventional ones that give a count, is one of 36 that started in 2026, is one of 78 with no phase, reaches primary completion later than 116 of the 161 other live ones, and was the 235th registered.
3,968 studies on the registry are indexed under Alzheimer Disease; 928 are open to participants now.
Browse Alzheimer Disease studies →150 of the 260 studies in Alzheimer Disease with a site in China are open now. Recruiting first, the newest first:
Fudan University · Sites in China
Ages 18+
Hoffmann-La Roche · Sites in China, United States, Argentina and 7 more countries
Ages 55–80
Eli Lilly and Company · Sites in China, United States, Japan
Ages 18–85 · Healthy volunteers
Anhui Medical University · Sites in China
Ages 45–84
JYAMS PET Research & Development Limited · Sites in China
Ages 50+ · Healthy volunteers
A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →
Of the 643 Alzheimer Disease studies recruiting now, 284 (44%) set no upper age limit and 55 (9%) stop at 75 or younger; 34 take children under 18; 285 take healthy volunteers.
This study: 50 Years to 80 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
260 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 31 · Phase 2 28 · Phase 3 36 · Phase 4 11
First in 2000; this study’s year is marked. 36 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 216 is above the median of 70 across 3,021 interventional studies indexed under Alzheimer Disease.
Median enrollment 100 across the 176 interventional studies, 566 across the 84 observational. Of the 65 that completed or were terminated, 16 (25%) have results posted.
This tab as a report to print or save as PDF → With an account.
68 of 260 have an industry lead sponsor. The 10 most frequent:
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University is the lead sponsor of 164 studies on the registry; 73 are open to participants now.
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University has 1 study filed under Alzheimer Disease — fewer than ten, so there is no comparison to draw.
44 of the studies in Alzheimer Disease with a site in China that are under way reach primary completion within a year, 8 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06585787Phase 3Karuna Therapeutics, Inc., a Bristol Myers Squibb companyA Study to Evaluate KarXT as a Treatment for Psychosis Associated With Alzheimer's Disease (ADEPT-4) | 2026-11-24 |
| NCT07422857Phase 3JYAMS PET Research & Development LimitedEvaluate the Use of [18F]-APN-1607 PET in Subjects With AD-related Cognitive Impairment and Subjects With Normal Cognitive Function | 2026-12-01 |
| NCT06126224Phase 3Karuna Therapeutics, Inc., a Bristol Myers Squibb companyA Study to Assess Efficacy and Safety of KarXT for the Treatment of Psychosis Associated With Alzheimer's Disease (ADEPT-2) | 2026-12-09 |
| NCT03887455Phase 3Eisai Inc.A Study to Confirm Safety and Efficacy of Lecanemab in Participants With Early Alzheimer's Disease | 2026-12-31 |
| NCT07323914Phase 3Xuanwu Hospital, BeijingClinical Analgesic Management in Dementia | 2027-01-01 |
Add all 44 to your calendar (.ics) → With an account.
Among the 260 studies in Alzheimer Disease with a site in China, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Procedure: Cervical lymph vessel/node-venous anastomosis surgery combined with oral donepezil · Drug: Oral treatment with donepezil
Drug: Oral treatment with donepezil
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.
Drug page: Donepezil
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.
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.
Time frame: Baseline and Month 12
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.
Time frame: Baseline and Month 18
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.
Time frame: Baseline and Month 18
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.
Time frame: Baseline and Month 18
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.
Time frame: Baseline and Month 18
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.
Time frame: Baseline and Month 18
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.
Time frame: Baseline and Month 18
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.
Time frame: Baseline and Month 18
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.
Time frame: Baseline and Month 18
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.
Time frame: Baseline and Month 18
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.
Time frame: Baseline and Month 18
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.
Time frame: Baseline and Month 18
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.
Time frame: Baseline and Month 18
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.
Time frame: Baseline and Month 18
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.
Time frame: During surgery
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).
Time frame: During surgery
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).
Time frame: During surgery
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).
Time frame: During surgery
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).
Time frame: During surgery
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).
Time frame: During surgery
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).
Time frame: During surgery
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).
Time frame: During surgery
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).
Time frame: During surgery
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).
Time frame: During surgery
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).
Time frame: During surgery
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).
Time frame: During surgery
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).
Time frame: During surgery
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).
Time frame: During surgery
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).
Time frame: During surgery
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).
Time frame: During surgery
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).
Time frame: During surgery
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).
Time frame: During surgery
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).
Time frame: During surgery
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.
Time frame: Baseline and Month 18
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.
Time frame: Baseline and Month 18
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.
Time frame: Baseline and Month 18
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.
Time frame: Baseline and Month 18
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.
Time frame: Baseline and Month 18
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.
Time frame: Baseline and Month 18
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.
Time frame: Baseline and Month 18
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.
Time frame: Baseline and Month 18
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.
Time frame: Baseline and Month 18
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.
Time frame: Baseline and Month 18
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.
Time frame: Baseline and Month 18
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.
Time frame: Baseline and Month 18
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.
Time frame: Baseline and Month 18
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.
Time frame: Baseline and Month 18
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.
Time frame: Baseline and Month 18
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.
Time frame: Baseline and Month 18
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.
Time frame: Baseline and Month 18
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.
Time frame: Baseline and Month 18
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.
Time frame: Baseline and Month 18
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.
Time frame: Baseline and Month 18
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.
Time frame: Baseline and Month 18
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.
Time frame: Baseline and Month 18
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.
Time frame: Baseline and Month 18
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.
Time frame: Baseline and Month 18
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.
Time frame: Baseline and Month 18
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.
Time frame: Baseline and Month 18
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.
Time frame: Baseline and Month 18
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.
Time frame: Baseline and Month 18
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.
Time frame: Baseline and Month 18
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.
Time frame: Baseline and Month 18
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.
Time frame: Baseline and Month 18
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.
Time frame: Baseline and Month 18
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.
Time frame: Baseline and Month 18
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.
Time frame: Baseline and Month 18
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.
Time frame: Baseline and Month 18
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.
Time frame: Baseline and Month 18
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.
Time frame: Baseline and Month 18
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.
Time frame: Baseline and Month 18
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Start is estimated for Jul 2026; primary completion for Sep 2028, 26 months later.
Of 885 non-industry interventional studies with no phase under Alzheimer Disease, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 51. This study's planned 26 months is below that.
Counting every sponsor, half of 962 studies reached it within 29 months; a quarter within 15 and three quarters within 51.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University →