Intracranial AtherosclerosisNCT06336174
Cognitive Decline and Underlying Mechanisms in Symptomatic Intracranial Artery Stenosis Patients: A Cohort Study
An observational study of Intracranial Atherosclerosis and Cognitive Impairment, run by Anhui Medical University at 1 site in China.
Trial summary
The purpose of this study is to explore the mechanism of cognitive impairment in patients with symptomatic intracranial atherosclerotic stenosis (ICAS), and further plans to explore the impact of different treatment options on cognitive function in symptomatic ICAS patients. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Intracranial Atherosclerosis, Cognitive Impairment, Cerebrovascular Event
- What is being tested?
- Aspirin Tablet, Clopidogrel Bisulfate Tablets and Atorvastatin and Endovascular therapy,Aspirin Tablet, Clopidogrel Bisulfate Tablets and Atorvastatin
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2022to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with intracranial stenosis which was defined as stenosis of 70% or more in Intracranial segment of internal carotid artery and middle cerebral artery (MCA) with transient ischemic attack or minor stroke(NIHSS≤4 points).The degree of stenosis was measured by transcranial doppler, computed magnetic resonance angiography (MRA),tomography angiography (CTA) and digital subtraction angiography (DSA).
Who may be able to join
- Age between 18 and 80 years
- Severe stenosis (≥70%-99%) of atherosclerotic internal carotid artery (C6 segment, C7 segment) or middle cerebral artery (M1 segment) confirmed by digital subtraction angiography (DSA) or at least two of the following non-invasive examinations: magnetic resonance angiography (MRA), computed tomography angiography (CTA), or transcranial Doppler (TCD)
- Transient ischemic attack (TIA) or minor stroke (National Institute of Health Stroke Scale [NIHSS] score ≤ 4 points)
- Right-handed and able to cooperate in neuropsychological tests
- At least 14 days post-onset of cerebral infarction or TIA
- Signed informed consent
Who cannot join
- Other diseases that affect cognitive function, such as cerebral hemorrhage, •Parkinson's disease, neurosyphilis, dementia, tumors, etc.
- Right upper limb hemiplegia, aphasia, visual field defects, or visual impairments
- More than 50% stenosis of the extracranial internal carotid artery, the vertebral artery, or the basilar artery
- Vasculitis, moyamoya disease, and cardiogenic stroke
- Previous history of head and neck stent implantation, carotid endarterectomy, aneurysm embolization, or other intracranial surgeries
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Anhui Medical University
Hefei, Anhui, 230032
Qiang Wei, PhD, +8618788836237, qiangwei_914@126.com
About this study
Official title: Cognitive Decline and Underlying Mechanisms in Symptomatic Intracranial Atherosclerotic Stenosis Patients: A Multicenter Cohort Study
The purpose of this study is to explore the mechanism of cognitive impairment in patients with symptomatic intracranial atherosclerotic stenosis (ICAS), and further plans to explore the impact of different treatment options on cognitive function in symptomatic ICAS patients.
Read the detailed description
All participants underwent a medical evaluation that included routine laboratory studies before and after 3-month and 1-year follow-up. Upon meeting the inclusion criteria and providing informed consent, each participant will complete a battery measure of neuropsychological tests, blood sample collection, and magnetic resonance imaging scan after enrollment and after 3-month and 1-year follow-up.
About 100 participants were included in this study. A series of neuropsychological tests were obtained by a trained investigator to assess. The tests include the evaluation of global cognitive function and multiple individual cognitive domains. The various tasks and questionnaires to measure cognition function including Montreal Cognitive Assessment (MoCA), Mini Mental State Examination (MMSE), Chinese Auditory Verbal Learning Test (CAVLT), Digital Span Test (DST), , Stroop color test (Stroop test), Color trail test (CTT), Clock Drawing Test (CDT), Verbal Fluency Test (VFT), etc., at the same time, the investigators also pay attention to the evaluation of participants' emotions by Hamilton Anxiety Scale (HAMA), Hamilton Depression Scale (HAMD). Furthermore, the memory and the occurrence of cerebrovascular events as the primary outcome measure, this study focused on the multidimensional cognitive function and cerebrovascular events of patients with symptomatic ICAS. Blood sample will be collected for biological multiomics research. The patients will receive a magnetic resonance imaging scan in multi-modalities.
After 3-month and 1-year follow-up, the participants will be interviewed to obtain the same assessments, blood sample and magnetic resonance imaging scan in multi-modalities as before.
- Being tested
- Aspirin Tablet, Clopidogrel Bisulfate Tablets and Atorvastatin, Endovascular therapy,Aspirin Tablet, Clopidogrel Bisulfate Tablets and Atorvastatin
- Keywords
- Symptomatic Intracranial Atherosclerosis Stenosis, Cognitive Impairment, Cerebravascular Event
- Medical subject headings
- Intracranial Arteriosclerosis, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aspirin Tablet, Clopidogrel Bisulfate Tablets and AtorvastatinDrug
All patients received standard medical management, including dual antiplatelet therapy (aspirin and clopidogrel) for three months with aspirin or clopidogrel monotherapy thereafter and high-dose statin, and treatment of hypertension to guideline targets.
Endovascular therapy,Aspirin Tablet, Clopidogrel Bisulfate Tablets and AtorvastatinProcedure or surgery
All patients underwent endovascular therapy and received standard medical management after surgery, including dual antiplatelet therapy (aspirin and clopidogrel) for three months with aspirin or clopidogrel monotherapy thereafter and high-dose statin, and treatment of hypertension to guideline targets.
| Study group | Role | What they receive |
|---|---|---|
| Surgery Group | Symptomatic intracranial stenosis patients who receive endovascular therapy combined with standard medical treatment Receives: Procedure: Endovascular therapy,Aspirin Tablet, Clopidogrel Bisulfate Tablets and Atorvastatin | |
| Medical group | Symptomatic intracranial stenosis patients who receive standard medical treatment without endovascular therapy Receives: Drug: Aspirin Tablet, Clopidogrel Bisulfate Tablets and Atorvastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
The changes in Memory
The changes in Memory function will constitute one of the main indicators of research results, which will be used to evaluate the follow-up results of the standard treatment regimen. The investigators will use the Chinese Auditory Verbal Learning Test (CAVLT) to evaluate the immediate, delayed and recognition memory of patients with symptomatic ICAS to evaluate the immediate, delayed and recognition memory of patients with ICAS.
Measured: baseline, 3-month and 1-year follow-up
Occurrence of ischemic cerebrovascular events
The changes in occurrence of ischemic cerebrovascular events constitute another major indicator of research result. The new responsible cerebrovascular events during the follow-up period are also the clinical information the investigators pay attention to, including transient ischemic attack (TIA) and stroke.
Measured: baseline, 3-month and 1-year follow-up
Secondary outcomes (17)
MoCA (Montreal Cognitive Assessment)
The changes in MoCA will constitute the secondary research outcome. MoCA was based on clinical experience and reference to the MMSE cognitive items and scores, and the final version was finalized in November 2004. The investigators adopted a localized version (Mandarin-8.1 version) in line with the Chinese cultural background. It includes 11 inspection items in 8 cognitive fields, including visual structure skills, executive function, naming, attention and calculation, language, abstract thinking, memory, and orientation. With a total score of 30 or more than 26, it is normal. Anyone who has been education for less than 12 years will need to add one point to his final score. The final score of the higher the better.
Measured: baseline, 3-month and 1-year follow-up
MMSE (Mini Mental State Examination)
The changes in MMSE will also constitute the secondary research outcome. The full name of MMSE is mini-mental state examination, and the scale consists of 30 subjects, include the following seven aspects: time orientation, place orientation, immediate memory, attention and calculation, delay memory, language, visual space. One point is awarded for each question correctly answered during MMSE evaluation. If subject give the wrong answer or don't know answer he/she awarded 0 score, scope of scale score of 0 to 30 points. The higher the score, the better. In this study, the investigators suspect that scores would decrease after follow-up.
Measured: baseline, 3-month and 1-year follow-up
DST (Digital Span Test; Forward and Backward)
The changes in DST will constitute the secondary research outcome. Digital span test (DST) was commonly used to evaluate attention ability and instantaneous memory ability. There are two types of test: forward (0-14) and backward (0-13). In the forward test, the subjects were asked to retell the the digits immediately after hearing it until they could not be repeated correctly. In backward test, the subjects were asked to repeat a set of numbers in reverse order until they could not be repeated correctly. The length of the last set of Numbers correctly repeated by the subjects was the final score, forward and backward are counted separately. The higher the score, the better. In this study, the investigators suspect that scores would decrease after follow-up.
Measured: baseline, 3-month and 1-year follow-up
The Stroop Color Test
The changes in The Stroop color test will constitute the secondary research outcome measure. The Stroop color word test was developed by Stroop in 1935 and is used to evaluate the attention function of the subject. The subject is required to correctly read the target color on the stimulus card and record the completion time. The final completion time is the score of the participant. The shorter the time used, the better the performance of the subjects
Measured: baseline, 3-month and 1-year follow-up
CTT (Color Trail Test)
The changes in CTT will constitute the secondary research outcome. The Color Trail Test (CTT) is divided into two parts, part A and part B. Part A requires the subject to connect 25 Numbers on the paper in sequence, and part B requires the subject to connect 25 Numbers of different colors alternately in sequence. The time it takes for the subject to complete all the Numbers is the subject's final score.In this study, the investigators suspect that scores would decrease after follow-up.
Measured: baseline, 3-month and 1-year follow-up
CDT (Clock drawing test)
The clock drawing test is currently widely used in the evaluation of cognitive impairment, requiring a free hand drawing of a clock within 10 minutes with the pointer pointing towards 11:10, which can be well used to evaluate the visual spatial ability of participants. The commonly used scoring methods include the 3-point method, the 4-point method, and the 10-point method.
Measured: baseline, 3-month and 1-year follow-up
VFT (Verbal Fluency Test)
The changes in The Verbal Fluency Test (VFT) will constitute the secondary research outcome measure. The VFT can be used to evaluate the frontal lobe fluency of patients, mainly including semantic verbal fluency and phonemic verbal fluency.
Measured: baseline, 3-month and 1-year follow-up
HAMD (Hamilton Depression Scale)
The changes in HAMD will constitute the secondary research outcome. Hamilton Depression Scale (HAMD) compiled by Hamilton in 1960, is the most common clinical to assess Depression Scale. In this study, 17 versions were selected, and there were 17 questions. The subjects were assessed for their depression in the past week. Each question scored between 0 and 4 points.Higher scores indicate more depressive symptoms.
Measured: baseline, 3-month and 1-year follow-up
HAMA (Hamilton Anxiety Scale)
The changes in HAMA will constitute the secondary research outcome. Hamilton Anxiety Scale (HAMA) was compiled by Hamilton in 1959.It was one of the most commonly used scales in psychiatric clinic, including 14 items. It is often used in clinical diagnosis and degree classification of anxiety disorder. The subjects were assessed for their anxiety in the past week. Each question scored between 0 and 4 points. The higher the score, the more symptoms of anxiety.
Measured: baseline, 3-month and 1-year follow-up
MRI measure- resting state MRI images
The resting state magnetic resonance data were collected to compare the neuroimaging differences between the patients and healthy control groups.
Measured: baseline, 3-month and 1-year follow-up
MRI measures-structural phase MRI images
The structural phase magnetic resonance data were collected to compare the neuroimaging differences between the patients and healthy control groups.
Measured: baseline, 3-month and 1-year follow-up
MRI measures-3D pCASL images
The three-dimensional pseudo continuous Arterial Spin Labeling (3D pCASL) data were collected to compare the differences in cerebral perfusion between the patients and healthy control groups.
Measured: baseline, 3-month and 1-year follow-up
Ultrasound measures-MCA-PI (middle cerebral artery-pulsatility index)
Pulsatility index (PI) in the middle cerebral artery (MCA) is considered a measure of peripheral vascular resistance. The investigators want to explore the peripheral vascular resistance by MCA-PI.
Measured: baseline, 3-month and 1-year follow-up
Ultrasound measures-IMT (intima-media thickness)
The carotid intima-media thickness (IMT) is a widely used surrogate marker for atherosclerosis worldwide. The investigators want to explore the risk of recurrence of cerebrovascular events by IMT.
Measured: baseline, 3-month and 1-year follow-up
Blood Metabolomics measures-CRP (C-reactive protiein)
CRP is a plasma protein synthesized by the liver and is often used as a nonspecific biomarker of inflammation. Elevated CRP levels are associated with increased risk of cerebrovascular disease and dementia. The investigators intend to use CRP to explore the relationship between inflammatory response and cognitive impairment.
Measured: baseline, 3-month and 1-year follow-up
Blood Metabolomics measures-oxLDL(Oxidized low-density lipoprotein)
Oxidized low-density lipoprotein (oxLDL) is a biomarker that is a key factor for the occurrence and development of atherosclerosis and the formation of unstable plaque. Atherosclerosis has been associated with the onset, severity and progression of cognitive dysfunction. The investigators intend to further explore the relationship between LDL level and cognitive impairment.
Measured: baseline, 3-month and 1-year follow-up
Blood Metabolomics measures-miRNA/microRNA
microRNA (miRNA) is a type of non-coding single-stranded small RNA that plays a role in biological functions by regulating post-transcriptional gene expression. miRNA is involved in the regulation of synaptic plasticity and is related to learning and memory. The investigators intend to reserve serum samples for the study of miRNA and cognitive impairment.
Measured: baseline, 3-month and 1-year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2024
- Study start1 Nov 2022
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intracranial AtherosclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Anhui Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, WANG KAI, Anhui Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06336174
- Sponsor's protocol ID
- Anhui-SIA-cohort
- Status last verified
- Nov 2025
- First submitted
- 22 Mar 2024
- Last updated
- 17 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Decline and Underlying Mechanisms in Symptomatic Intracranial Atherosclerotic Stenosis Patients: A Multicenter Cohort Study
- ClinicalTrials.gov ID
- NCT06336174
- Acronym / sponsor ID
- Anhui-SIA-cohort
- Keywords
- Symptomatic Intracranial Atherosclerosis Stenosis, Cognitive Impairment, Cerebravascular Event
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Anhui Medical UniversityUniversity, hospital or other
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 28 Mar 2024 (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.
The purpose of this study is to explore the mechanism of cognitive impairment in patients with symptomatic intracranial atherosclerotic stenosis (ICAS), and further plans to explore the impact of different treatment options on cognitive function in symptomatic ICAS patients.
Detailed description
All participants underwent a medical evaluation that included routine laboratory studies before and after 3-month and 1-year follow-up. Upon meeting the inclusion criteria and providing informed consent, each participant will complete a battery measure of neuropsychological tests, blood sample collection, and magnetic resonance imaging scan after enrollment and after 3-month and 1-year follow-up.
About 100 participants were included in this study. A series of neuropsychological tests were obtained by a trained investigator to assess. The tests include the evaluation of global cognitive function and multiple individual cognitive domains. The various tasks and questionnaires to measure cognition function including Montreal Cognitive Assessment (MoCA), Mini Mental State Examination (MMSE), Chinese Auditory Verbal Learning Test (CAVLT), Digital Span Test (DST), , Stroop color test (Stroop test), Color trail test (CTT), Clock Drawing Test (CDT), Verbal Fluency Test (VFT), etc., at the same time, the investigators also pay attention to the evaluation of participants' emotions by Hamilton Anxiety Scale (HAMA), Hamilton Depression Scale (HAMD). Furthermore, the memory and the occurrence of cerebrovascular events as the primary outcome measure, this study focused on the multidimensional cognitive function and cerebrovascular events of patients with symptomatic ICAS. Blood sample will be collected for biological multiomics research. The patients will receive a magnetic resonance imaging scan in multi-modalities.
After 3-month and 1-year follow-up, the participants will be interviewed to obtain the same assessments, blood sample and magnetic resonance imaging scan in multi-modalities as before.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Surgery Group | – | Procedure: Endovascular therapy,Aspirin Tablet, Clopidogrel Bisulfate Tablets and AtorvastatinSymptomatic intracranial stenosis patients who receive endovascular therapy combined with standard medical treatment |
| Medical group | – | Drug: Aspirin Tablet, Clopidogrel Bisulfate Tablets and AtorvastatinSymptomatic intracranial stenosis patients who receive standard medical treatment without endovascular therapy |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with intracranial stenosis which was defined as stenosis of 70% or more in Intracranial segment of internal carotid artery and middle cerebral artery (MCA) with transient ischemic attack or minor stroke(NIHSS≤4 points).The degree of stenosis was measured by transcranial doppler, computed magnetic resonance angiography (MRA),tomography angiography (CTA) and digital subtraction angiography (DSA).
Key inclusion criteria (6 listed)
- Age between 18 and 80 years
- Severe stenosis (≥70%-99%) of atherosclerotic internal carotid artery (C6 segment, C7 segment) or middle cerebral artery (M1 segment) confirmed by digital subtraction angiography (DSA) or at least two of the following non-invasive examinations: magnetic resonance angiography (MRA), computed tomography angiography (CTA), or transcranial Doppler (TCD)
- Transient ischemic attack (TIA) or minor stroke (National Institute of Health Stroke Scale [NIHSS] score ≤ 4 points)
- Right-handed and able to cooperate in neuropsychological tests
- At least 14 days post-onset of cerebral infarction or TIA
Key exclusion criteria (5 listed)
- Other diseases that affect cognitive function, such as cerebral hemorrhage, •Parkinson's disease, neurosyphilis, dementia, tumors, etc.
- Right upper limb hemiplegia, aphasia, visual field defects, or visual impairments
- More than 50% stenosis of the extracranial internal carotid artery, the vertebral artery, or the basilar artery
- Vasculitis, moyamoya disease, and cardiogenic stroke
- Previous history of head and neck stent implantation, carotid endarterectomy, aneurysm embolization, or other intracranial surgeries
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 |
|---|---|---|
| Aspirin Tablet, Clopidogrel Bisulfate Tablets and AtorvastatinAll patients received standard medical management, including dual antiplatelet therapy (aspirin and clopidogrel) for three months with aspirin or clopidogrel monotherapy thereafter and high-dose statin, and treatment of hypertension to guideline targets. | Drug | Medical group |
| Endovascular therapy,Aspirin Tablet, Clopidogrel Bisulfate Tablets and AtorvastatinAll patients underwent endovascular therapy and received standard medical management after surgery, including dual antiplatelet therapy (aspirin and clopidogrel) for three months with aspirin or clopidogrel monotherapy thereafter and high-dose statin, and treatment of hypertension to guideline targets. | Procedure or surgery | Surgery Group |
Primary outcome
The changes in Memory
Time frame: baseline, 3-month and 1-year follow-up
The changes in Memory function will constitute one of the main indicators of research results, which will be used to evaluate the follow-up results of the standard treatment regimen. The investigators will use the Chinese Auditory Verbal Learning Test (CAVLT) to evaluate the immediate, delayed and recognition memory of patients with symptomatic ICAS to evaluate the immediate, delayed and recognition memory of patients with ICAS.
Occurrence of ischemic cerebrovascular events
Time frame: baseline, 3-month and 1-year follow-up
The changes in occurrence of ischemic cerebrovascular events constitute another major indicator of research result. The new responsible cerebrovascular events during the follow-up period are also the clinical information the investigators pay attention to, including transient ischemic attack (TIA) and stroke.
17 secondary outcomes
MoCA (Montreal Cognitive Assessment)
Time frame: baseline, 3-month and 1-year follow-up
MMSE (Mini Mental State Examination)
Time frame: baseline, 3-month and 1-year follow-up
DST (Digital Span Test; Forward and Backward)
Time frame: baseline, 3-month and 1-year follow-up
The Stroop Color Test
Time frame: baseline, 3-month and 1-year follow-up
CTT (Color Trail Test)
Time frame: baseline, 3-month and 1-year follow-up
CDT (Clock drawing test)
Time frame: baseline, 3-month and 1-year follow-up
VFT (Verbal Fluency Test)
Time frame: baseline, 3-month and 1-year follow-up
HAMD (Hamilton Depression Scale)
Time frame: baseline, 3-month and 1-year follow-up
HAMA (Hamilton Anxiety Scale)
Time frame: baseline, 3-month and 1-year follow-up
MRI measure- resting state MRI images
Time frame: baseline, 3-month and 1-year follow-up
MRI measures-structural phase MRI images
Time frame: baseline, 3-month and 1-year follow-up
MRI measures-3D pCASL images
Time frame: baseline, 3-month and 1-year follow-up
Ultrasound measures-MCA-PI (middle cerebral artery-pulsatility index)
Time frame: baseline, 3-month and 1-year follow-up
Ultrasound measures-IMT (intima-media thickness)
Time frame: baseline, 3-month and 1-year follow-up
Blood Metabolomics measures-CRP (C-reactive protiein)
Time frame: baseline, 3-month and 1-year follow-up
Blood Metabolomics measures-oxLDL(Oxidized low-density lipoprotein)
Time frame: baseline, 3-month and 1-year follow-up
Blood Metabolomics measures-miRNA/microRNA
Time frame: baseline, 3-month and 1-year follow-up
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 17 Nov 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intracranial Atherosclerosis and Cognitive Impairment, run by Anhui Medical 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 6 inclusion and 5 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 17 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kai Wang, PhD (+86-0551-62922263, wangkai1964@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The changes in Memory (time frame: baseline, 3-month and 1-year follow-up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2025.