Alzheimers DiseaseNCT07073066
Deep Cervical Lymphatic Venous Anastomosis in the Treatment of Alzheimer's Disease (CLEAN-AD)
A study of Alzheimers Disease, run by Beijing Tiantan Hospital at 9 sites in China.
Trial summary
This multicenter, prospective, open-label, blinded-endpoint, randomized controlled trial is to evaluate the efficacy and safety of deep cervical lymphatic venous anastomosis (DC-LVA) plus usual care versus usual care in reduing the score of clinical dementia rating-sum of boxes (CDR-SB) at 12 months in patients with… Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Alzheimers Disease
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 376 participants
- Where
- 9 sitesChina
- Study dates
- 13 Mar 2026to 30 Nov 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
- Age 50-80 years, male or female.
- Diagnosed with AD according to NIA-AA criteria.
- Moderate-to-severe AD dementia, defined as Clinical Dementia Rating Scale Global Score (CDR-GS) ≥1.
- Mini-Mental State Examination (MMSE) score 10-20.
- The course of AD more than 6 months.
- If receiving an approved AD treatment, must be on a stable drug dose for at least 3 months prior to Baseline. AD Treatment-naïve subjects can be entered into the study.
- Have an identified caregiver (defined as a person able to support the subject for the duration of the study and who spends at least 8 hours per week with the subject). The caregiver must accompany with the participant at all study follow-up visits.
- Signed informed consent (from the participant or their relative, and the caregiver).
Who cannot join
- Any neurological condition other than AD that may affect cognitive function, including stroke, Parkinson's disease, epilepsy, intracranial tumors or space-occupying lesions, traumatic brain injury, intracranial infections, metabolic encephalopathy, etc.
- Other causes of dementia, including vascular dementia, hereditary cerebral small vessel disease, vitamin deficiency, or any other etiology leading to dementia.
- Previous evidence of severe stenosis (≥70%) in the middle cerebral artery and/or internal carotid artery.
- Presence of primary psychiatric disorders (such as schizophrenia, schizoaffective disorder, major depressive disorder, or bipolar disorder) rather than psychiatric symptoms caused by AD.
- 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.
- History of drug or alcohol abuse or dependence.
Show all 18Show fewer
- History of malignant tumors or prior radiotherapy or surgery involving the head and neck.
- Major surgical procedures or severe head or body trauma within the past 30 days.
- Presence of other life-threatening conditions with an expected survival time of less than 2 years.
- Contraindications to head MRI (including cardiac pacemakers/defibrillators, ferromagnetic metal implants, etc.).
- Severe diseases or functional impairment of the heart, lungs, liver, kidneys, or other solid organs, making the patient unable to tolerate anesthesia or DC-LVA.
- Severe bleeding tendency (including but not limited to): platelet count <100×10⁹/L; heparin therapy within the last 48 hours with APTT ≥35 seconds; ongoing warfarin use with INR >1.7.
- Requirement for long-term use of antithrombotic medications, with inability to discontinue them before surgery or potential risks associated with discontinuation.
- Uncontrolled persistent hypertension (systolic blood pressure >160 mmHg or diastolic blood pressure >95 mmHg).
- Co-infection with HIV or Treponema pallidum, or any uncontrolled infectious disease.
- Use of other investigational drugs or devices within 30 days prior to obtaining informed consent, or current participation in other interventional clinical studies.
- Pregnancy, lactation, potential for pregnancy, or plans for pregnancy during the study period.
- Immediate family members of the investigator (spouse, parents, children, or siblings), staff of the research institution or third-party organizations, or any other individuals with potential conflicts of interest related to the study.
Trial locations and contacts
9 sites in 1 country. Contact the study team or a site near you to ask about taking part.
9 sites in 1 country
China9 sites, 8 recruiting
- Recruiting
Beijing Tiantan Hopital, Capital Medical University
Beijing, 100070
Yijia Guo, phD, 0086-010-59975029, guoyijia_cmu@163.com
Yuesong Pan, phD, 0086-010-59975029, yuesongpan@aliyun.com
- Recruiting
Dongguan Chashan Hospital
Dongguan, Guangdong
Haiwen Wang, 0086-13609048317, shizetianv@163.com
- Recruiting
Guangdong Second People's Hospital
Guangdong, Guangzhou, 510000
Ping Luan, 13612992682, luanping@szu.edu.cn
- Active, not recruiting
First Affiliated Hospital of Shandong First Medical University
Jinan, Shandong, 250000
- Recruiting
Shandong Provincial Public Health Clinical Center
Jinan, Shandong, 250000
Qinghua Zhang, 0086-15168863112, zhang.qinghua@outlook.com
- Recruiting
Shandong Provincial Third Hospital
Jinan, Shandong, 250000
Tingzhong Wang, 0086-18900912311, wangtingzhong@126.com
Tingzhong Wang
- Recruiting
Jining First People's Hospital
Jining, Shandong, 272000
Lei Feng, 0086-13181326326, flneuro@163.com
Lei Feng
- Recruiting
The First Affiliated Hospital of Ningbo University
Ningbo, Zhejiang, 315000
Xiang Gao, 0086-18888611859, yehand120@163.com
Zhaohui Ye
- Recruiting
Zhengzhou Central Hospital
Zhengzhou, Henan, 450000
Xiwen Ma, 0086-13623805170, zmydocument@163.com
About this study
Official title: Deep Cervical Lymphatic Venous Anastomosis in the Treatment of Alzheimer's Disease: A Multicenter, Prospective, Open-label, Blinded-Endpoint, Randomized Controlled Trial (CLEAN-AD)
This multicenter, prospective, open-label, blinded-endpoint, randomized controlled trial is to evaluate the efficacy and safety of deep cervical lymphatic venous anastomosis (DC-LVA) plus usual care versus usual care in reduing the score of clinical dementia rating-sum of boxes (CDR-SB) at 12 months in patients with moderate-to-severe Alzheimer's Disease (AD).
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. For patients with moderate-to-severe AD, who comprise approximately 50% of the existing AD population, there are limitied treatment options in clinical practice. A series of case studies has suggested the efficacy of deep cervical lymphatic venous anastomosis (DC-LVA) in AD patients, however, there is currently no evidence from randomized controlled clinical trials.
The primary purpose of this study is to evaluate the efficacy and safety of deep cervical lymphatic venous anastomosis (DC-LVA) plus usual care versus usual care in reduing the score of clinical dementia rating-sum of boxes (CDR-SB) at 12 months in patients with moderate-to-severe Alzheimer's Disease (AD). This study also aims to assess the efficacy and safety of DC-LVA in reducing AD biomarker levels of brain Aβ PET imaging.
This trial is a multicenter, prospective, open-label, blinded-endpoint, randomized controlled trial. A total of 754 patients in 20 centers from China will be enrolled. Patients will be randomly assigned into DC-LVA plus usual care or usual care according to the ratio of 1:1. Face to face interviews will be made at baseline, 7 days (or hospital discharge), 3th months ± 7 days, 6th months ± 15 days, 9th months ± 15 days and 12th month ± 15 days after randomization. After 12 months, there will be 12 months open-label extension of follow-up, participants in the control group can choose to conduct DC-LVA. During the open-label extension phase, follow-up visits will be conducted every 3 months until 24th months after randomization.
Primary outcome is defined as the change of CDR-SB score at 12th months after randomization. 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 in the DC-LVA treatment group will be summarized using counts/percentages. Adverse events and serious adverse events will be summarized.
In exploratory outcome measures, the investigators will analyse the AD associated biomarkers in lymphatic tissue in the intervetnon group during the surgery, and analyse the change of fluid biomarkers ( AD associated biomarkers in peripheral blood, saliva, urine, and cerebrospinal fluid), 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
- DC-LVA treatment plus usual care, Usual care
- Keywords
- Alzheimers disease, Cervical Lymphatic Venous Anastomosis, Randomized Controlled Trial
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DC-LVA treatment plus usual careProcedure or surgery
Also called 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.
Usual careOther
The usual care group includes patients who were not using or were currently using medications for improving cognitive function.
| Study group | Role | What they receive |
|---|---|---|
| DC-LVA treatment plus usual care | Experimental | The intervention requires to perform bilateral deep cervical lymphatic venous anastomosis (DC-LVA). The usual care includes patients who were not using or were currently using medications for improving cognitive function. Receives: Procedure: DC-LVA treatment plus usual care |
| Usual care | Active comparator | The usual care group includes patients who were not using or were currently using medications for improving cognitive function. Receives: Other: Usual care |
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 randomization
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 randomization
Secondary outcomes (15)
The Change of Clinician's Interview-Based Impression of Change plus caregiver input score
Clinician's Interview-Based Impression of Change plus caregiver input score (CIBIC-plus, 1-7 score, higher scores mean a worse outcome)
Measured: From baseline to 12th months after randomization
The Change of Neuropsychiatric Inventory Score
Neuropsychiatric Inventory Score (NPI, 0-144 score, higher scores mean a worse outcome)
Measured: From baseline to 12th months after randomization
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 randomization
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 12th months after randomization
The Change of Alzheimer's Disease Assessment Scale-Activity of Daily Living score
Alzheimer's Disease Assessment Scale-Activity of Daily Living score (ADCS-ADL, 0-78 score, higher scores mean a better outcome)
Measured: From baseline to 12th months after randomization
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 12th months after randomization
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, 9th months after randomization
The Change of Clinician's Interview-Based Impression of Change plus caregiver input score
Clinician's Interview-Based Impression of Change plus caregiver input score (CIBIC-plus, 1-7 score, higher scores mean a worse outcome)
Measured: From baseline to 3th, 6th, 9th months after randomization
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, 9th months after randomization
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, 9th months after randomization
The Change of Alzheimer's Disease Assessment Scale-Activity of Daily Living score
Alzheimer's Disease Assessment Scale-Activity of Daily Living score (ADCS-ADL, 0-78 score, higher scores mean a better outcome)
Measured: From baseline to 3th, 6th, 9th months after randomization
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, 9th months after randomization
The Change of Alzheimer's Disease Assessment Scale Cognitive Score
Alzheimer's Disease Assessment Scale Cognitive score (ADCS-Cog-13, 0-85 score, higher scores mean a worse outcome)
Measured: From baseline to 3th, 6th, 9th, 12th months after randomization
The Change of Severe Impairment Batterty Score
Severe Impairment Batterty Score (SIB, 0-100 score, higher scores mean a worse outcome)
Measured: From baseline to 3th, 6th, 9th, 12th months after randomization
The Change of Alzheimer's Disease Composite Score
Alzheimer's Disease Composite Score (ADCOMS, 0-1.97 score, higher scores mean a worse outcome) is calculated by a weighted items from three scales including ADCS-Cog, MMSE, and CDR-SB.
Measured: From baseline to 3th, 6th, 9th, 12th months after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2025
- Study start13 Mar 2026
- Primary completion30 Nov 2028 (estimated)
- Study completion30 Nov 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This multicenter, prospective, open-label, blinded-endpoint, randomized controlled trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 376 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
- NCT07073066
- Sponsor's protocol ID
- KY2025-089-02
- Status last verified
- May 2026
- First submitted
- 11 May 2025
- Last updated
- 12 May 2026
- 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 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Deep Cervical Lymphatic Venous Anastomosis in the Treatment of Alzheimer's Disease: A Multicenter, Prospective, Open-label, Blinded-Endpoint, Randomized Controlled Trial (CLEAN-AD)
- ClinicalTrials.gov ID
- NCT07073066
- Acronym / sponsor ID
- KY2025-089-02
- Conditions
- Alzheimers Disease
- Keywords
- Alzheimers disease, Cervical Lymphatic Venous Anastomosis, Randomized Controlled Trial
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 376 participants (estimated)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Study start
- 13 Mar 2026 (actual)
- Primary completion
- 30 Nov 2028 (estimated)
- Study completion
- 30 Nov 2029 (estimated)
- First posted
- 18 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, open-label, blinded-endpoint, randomized controlled trial is to evaluate the efficacy and safety of deep cervical lymphatic venous anastomosis (DC-LVA) plus usual care versus usual care in reduing the score of clinical dementia rating-sum of boxes (CDR-SB) at 12 months in patients with moderate-to-severe Alzheimer's Disease (AD).
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. For patients with moderate-to-severe AD, who comprise approximately 50% of the existing AD population, there are limitied treatment options in clinical practice. A series of case studies has suggested the efficacy of deep cervical lymphatic venous anastomosis (DC-LVA) in AD patients, however, there is currently no evidence from randomized controlled clinical trials.
The primary purpose of this study is to evaluate the efficacy and safety of deep cervical lymphatic venous anastomosis (DC-LVA) plus usual care versus usual care in reduing the score of clinical dementia rating-sum of boxes (CDR-SB) at 12 months in patients with moderate-to-severe Alzheimer's Disease (AD). This study also aims to assess the efficacy and safety of DC-LVA in reducing AD biomarker levels of brain Aβ PET imaging.
This trial is a multicenter, prospective, open-label, blinded-endpoint, randomized controlled trial. A total of 754 patients in 20 centers from China will be enrolled. Patients will be randomly assigned into DC-LVA plus usual care or usual care according to the ratio of 1:1. Face to face interviews will be made at baseline, 7 days (or hospital discharge), 3th months ± 7 days, 6th months ± 15 days, 9th months ± 15 days and 12th month ± 15 days after randomization. After 12 months, there will be 12 months open-label extension of follow-up, participants in the control group can choose to conduct DC-LVA. During the open-label extension phase, follow-up visits will be conducted every 3 months until 24th months after randomization.
Primary outcome is defined as the change of CDR-SB score at 12th months after randomization. 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 in the DC-LVA treatment group will be summarized using counts/percentages. Adverse events and serious adverse events will be summarized.
In exploratory outcome measures, the investigators will analyse the AD associated biomarkers in lymphatic tissue in the intervetnon group during the surgery, and analyse the change of fluid biomarkers ( AD associated biomarkers in peripheral blood, saliva, urine, and cerebrospinal fluid), 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This multicenter, prospective, open-label, blinded-endpoint, randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| DC-LVA treatment plus usual care | Experimental | Procedure: DC-LVA treatment plus usual careThe intervention requires to perform bilateral deep cervical lymphatic venous anastomosis (DC-LVA). The usual care includes patients who were not using or were currently using medications for improving cognitive function. |
| Usual care | Active comparator | Other: Usual careThe usual care group includes patients who were not using or were currently using medications for improving cognitive function. |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age 50-80 years, male or female.
- Diagnosed with AD according to NIA-AA criteria.
- Moderate-to-severe AD dementia, defined as Clinical Dementia Rating Scale Global Score (CDR-GS) ≥1.
- Mini-Mental State Examination (MMSE) score 10-20.
- The course of AD more than 6 months.
Key exclusion criteria (18 listed)
- Any neurological condition other than AD that may affect cognitive function, including stroke, Parkinson's disease, epilepsy, intracranial tumors or space-occupying lesions, traumatic brain injury, intracranial infections, metabolic encephalopathy, etc.
- Other causes of dementia, including vascular dementia, hereditary cerebral small vessel disease, vitamin deficiency, or any other etiology leading to dementia.
- Previous evidence of severe stenosis (≥70%) in the middle cerebral artery and/or internal carotid artery.
- Presence of primary psychiatric disorders (such as schizophrenia, schizoaffective disorder, major depressive disorder, or bipolar disorder) rather than psychiatric symptoms caused by AD.
- 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.
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 |
|---|---|---|
| DC-LVA treatment plus usual careAlso: LVAThrough 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 | DC-LVA treatment plus usual care |
| Usual careThe usual care group includes patients who were not using or were currently using medications for improving cognitive function. | Other | Usual care |
Primary outcome
The change of Clinical Dementia Rating-Sum of Boxes score at 12th months after randomization
Time frame: From baseline to 12th months after randomization
The change of Clinical Dementia Rating-Sum of Boxes score (CDR-SB, 0-18 score, higher scores mean a worse outcome)
15 secondary outcomes
The Change of Clinician's Interview-Based Impression of Change plus caregiver input score
Time frame: From baseline to 12th months after randomization
The Change of Neuropsychiatric Inventory Score
Time frame: From baseline to 12th months after randomization
The Change of Aβ PET-CT Centiloid value
Time frame: From baseline to 12th months after randomization
The Change of Zarit Caregiver Interview of Alzheimer's Disease Score
Time frame: From baseline to 12th months after randomization
The Change of Alzheimer's Disease Assessment Scale-Activity of Daily Living score
Time frame: From baseline to 12th months after randomization
The Change of Mini-Mental State Examination Score
Time frame: From baseline to 12th months after randomization
The Change of Clinical Dementia Rating-Sum of Boxes score
Time frame: From baseline to 3th, 6th, 9th months after randomization
The Change of Clinician's Interview-Based Impression of Change plus caregiver input score
Time frame: From baseline to 3th, 6th, 9th months after randomization
The Change of Neuropsychiatric Inventory Score
Time frame: From baseline to 3th, 6th, 9th months after randomization
The Change of Zarit Caregiver Interview of Alzheimer's Disease Score
Time frame: From baseline to 3th, 6th, 9th months after randomization
The Change of Alzheimer's Disease Assessment Scale-Activity of Daily Living score
Time frame: From baseline to 3th, 6th, 9th months after randomization
The Change of Mini-Mental State Examination Score
Time frame: From baseline to 3th, 6th, 9th months after randomization
The Change of Alzheimer's Disease Assessment Scale Cognitive Score
Time frame: From baseline to 3th, 6th, 9th, 12th months after randomization
The Change of Severe Impairment Batterty Score
Time frame: From baseline to 3th, 6th, 9th, 12th months after randomization
The Change of Alzheimer's Disease Composite Score
Time frame: From baseline to 3th, 6th, 9th, 12th months after randomization
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 12 May 2026.
- 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.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Alzheimers Disease, run by Beijing Tiantan Hospital at 9 sites 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 8 inclusion and 18 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: looking for participants now, as of the sponsor's last update on 12 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites 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 randomization (time frame: From baseline to 12th months after randomization). 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 12 May 2026.