Cognitive ImpairmentHERITAGENCT05886114
A Multi-domain Lifestyle Intervention Among Aged Community-residents in Zhejiang, China
A study testing Structured Multi-domain Intervention and Self-Guided Intervention in people with Cognitive Impairment and Alzheimer Disease, run by Zhejiang University at 1 site in China.
Trial summary
A study conducted in Finland discovered that a multidomain intervention, consisting of physical activity, nutritional guidance, cognitive training, social activities, and management of vascular risk factors, effectively decelerated cognitive decline in healthy older adults who were at an increased risk of cognitive… Read more about this study
- Who is it for?
- Ages 60 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Cognitive Impairment, Alzheimer Disease, Vascular Cognitive Impairment
- What is being tested?
- Structured Multi-domain Intervention and Self-Guided Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,200 participants
- Where
- 1 siteChina
- Study dates
- 28 May 2023to 28 Apr 2027
- 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 60 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- At risk of cognitive decline: cognitive performance at the mean level or slightly lower than expected for age with no dementia (AD8>=3 and/or 5-min MoCA >, < 11)
- Free of physical disabilities that preclude participation in the study
- Willing to complete all study-related activities for 24 months
- Willing to be randomized to either lifestyle intervention group
Who cannot join
- Diagnosed dementia patients
- Diagnosed major depression or other neuropsychological diseases
- Malignant diseases
- Symptomatic cardiovascular disease
- Revascularization within one year
- Severe loss of vision, hearing or communicative ability
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Changzheng Yuan, PhD contact
China1 site, 1 recruiting
- Recruiting
School of Public Health and The Second Affiliated Hospital of School of Medicine, Zhejiang University, Hangzhou, China
Hangzhou, Zhejiang, 310000
Xuhao Zhao, MPH, zhaoxuhao@zju.edu.cn
About this study
A study conducted in Finland discovered that a multidomain intervention, consisting of physical activity, nutritional guidance, cognitive training, social activities, and management of vascular risk factors, effectively decelerated cognitive decline in healthy older adults who were at an increased risk of cognitive decline. The HERITAGE study is a 2-year clustered randomized controlled trial (clustered-RCT) that explores the efficacy of a multidomain intervention among 1200 elderly residents with a higher risk of cognitive decline and dementia in Zhejiang Province, China
Read the detailed description
The effectiveness of a multidomain lifestyle intervention on the prevention of cognitive decline and dementia have not been studied in Asian elderly at high risk of dementia conversion. Dementia is caused by both nonmodifiable genetic variables, and modifiable lifestyle risk factors. While neuroimaging biomarkers have been well documented in the neurophysiology of ageing and age-associated cognitive decline, their role as surrogate endpoints and intermediate variables between multi-domain lifestyle intervention and cognitive benefits has not been studied. The current study aims to understand brain functional and structural changes that may result from a multi-domain lifestyle intervention and whether the changes correlate with improvement in cognitive function. At risk elderly aged 60-80 years will be randomly allocated to either the control arm (self-guided management) or the intervention (multi-domain lifestyle) arm, which consists of nutritional guidance, physical exercise, cognitive training and the monitoring and management of vascular and metabolic risk factors. We hypothesize that the multi-domain lifestyle intervention will promote favorable changes in cognitive function. Moreover, such intervention will slow down the progression of cerebrovascular disease and neurodegeneration in participants in the intervention arm. Findings from the present study will shed light on the biological mechanisms of age-related cognitive decline and neurodegenerative disease. Insight obtained from the study could be translated into new targets of nonpharmacological interventions which aim at the potential causal molecular pathways implicated in ageing and age-related cognitive decline. Adaption and implementation of our findings into clinical and public health practice will further promote healthy and confident ageing among Chinese elderly, to eventually expand their health span.
- Conditions
- Cognitive Impairment, Alzheimer Disease, Vascular Cognitive Impairment, Dement, Brain Diseases, Central Nervous System Diseases
- Being tested
- Structured Multi-domain Intervention, Self-Guided Intervention
- Medical subject headings
- Cognitive Dysfunction, Alzheimer Disease, Brain Diseases, Central Nervous System Diseases, Nervous System Diseases, Neurocognitive Disorders, Mental Disorders, Cognition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Structured Multi-domain InterventionBehavioural
Also called SMI
Structured Multi-domain Intervention (SMI) involves providing participants with intensive structure and support by a team of trainers to increase physical exercise, adhere to a healthy diet, cognitive training, increase intellectual/social stimulation, and better manage vascular risk factors.
Self-Guided InterventionBehavioural
Also called SGI
In the Self-Guided Intervention (SGI), education about the importance of a healthy lifestyle as a preventive strategy and support to encourage change will be provided.
| Study group | Role | What they receive |
|---|---|---|
| Structured Multi-domain Intervention | Experimental | Multi-domain structured intervention will be tailored by Chinese traditional and social norms and then conducted among the intervention group. That includes: Nutritional and dietary instruction, Cognitive training, Physical exercises, and Vascular risks monitoring and control. Receives: Behavioral: Structured Multi-domain Intervention |
| Self-Guided Intervention | Experimental | Every 6-12 months, control group will receive a regular health education campaign to encourage a healthy lifestyle and a regular health monitoring and examination of blood pressure, weight, fasting blood glucose and liposome group Receives: Behavioral: Self-Guided Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Global Cognition
Globe cognitive performance (composite z-score) measured by comprehensive Neuropsychological Test Battery (NTB)
Measured: Up to 2 years
Domain-specific Cognition
NTB domain-specific cognitive performance (composite z-score) for memory, executive function, attention, language, visuomotor speed and visuoconstruction.
Measured: Up to 2 years
Secondary outcomes (27)
Neuroimaging: MRA
Changes in brain blood flow assessed by magnetic resonance angiography(MRA)
Measured: Up to 2 years
Neuroimaging: MRI
Changes in brain structural integrity (gray matter volume loss, white matter microstructure degradation and increase of cerebrovascular markers) assessed by T1-weighted Magnetization Prepared Rapid Gradient Recalled Echo, Fluid Attenuated Inversion Recovery (FLAIR), T2-weighted, and Susceptibility Weighted Imaging sequences
Measured: Up to 2 years
Neuroimaging: fMRI
Changes in brain functional networks assessed by fMRI
Measured: Up to 2 years
Number of participants with Laboratory Values /Blood markers
Blood samples will be collected from all patients in tubes with ethylenediaminetetraacetic acid 0.1%. Changes in Novel and accessible blood markers to monitor AD- and CeVD- associated pathologies. Plasma concentrations of cardiac markers (High-sensitive cardiac troponin T (hs Troponin T), N-terminal pro b-type natriuretic peptide (NT-proBNP) and Growth/differentiation factor 15 (GDF 15)), and peripheral biomarkers of Aβ, tau and synaptic pathology, oxidative stress, endothelial/cardiovascular injury and degenerative protein modifications (DPMs) damaged proteins will be measured by laboratory testings.
Measured: Up to 2 years
Incident dementia
Incidence of dementia. Dementia diagnoses will be made by CDR and DSM-IV criteria.
Measured: Up to 2 years
Clinical Dementia Rating-Sum of Boxes (CDR-SB)
The Clinical Dementia Rating-Sum of Boxes (CDR-SB) is scored from 0 to 18. Higher scores reflect worse performance.
Measured: Up to 2 years
Alzheimer's Disease Cooperative Study Activities of Daily Living Mild Cognitive Impairment-Activities of Daily Living Inventory (ADCS MCI-ADL)
The Alzheimer's Disease Cooperative Study Activities of Daily Living-Mild Cognitive Impairment-Activities of Daily Living Inventory (ADCS MCI-ADL) is scored from 0 to 53. Higher scores reflect better performance.
Measured: Up to 2 years
Cardiovascular morbidity
Physician-diagnosed cardiometabolic health disorders will be identified based on ICD-9 or ICD-10 codes (in any position). Any incident cardiometabolic morbidity, for example, ardiac dysrhythmias, heart failure, peripheral and visceral atherosclerosis, non-alcoholic fatty liver disease, chronic kidney disease, type 2 diabetes, hypercholesterolemia, and hypertension, will be recorded.
Measured: Up to 2 years
Physical Performance: Grip strength
Grip strength will be assessed by a hydraulic hand dynamometer and expressed in absolute units(kilograms) andrelative units(kilograms divided by bodyweight).
Measured: Up to 2 years
Physical Performance: Gaid speed
Walking pace will be assessed by the speed (m/second) of completing a 1.5 meters walk.
Measured: Up to 2 years
Physical Performance: Balance
Balance will be measured by standing on one foot and expressed in absolute units(seconds).
Measured: Up to 2 years
Physical Performance: Endurance
Endurance will be assessed by the 2MW. Participants will be asked to "walk as fast as you can without running" for 2 minutes around a 50-foot course. A greater distance(m) indicates better endurance.
Measured: Up to 2 years
Physical Performance: Lower limb strength
Lower limb strength will be assessed by 30 second sit to stand test and expressed by completion times.
Measured: Up to 2 years
Quality of Life Questionnaire (15D)
The Quality of Life Questionnaire (15D) has a single index (15D score) on a 0-1 scale, which represents overall HRQoL (0 = being dead, 0.0162 = being unconscious or comatose, 1 = no problems on any dimension = 'full' HRQOL). This is calculated from the health state descriptive system by using a set of population-based preference or utility weights.
Measured: Up to 2 years
The Geriatric Depression Scale (GDS)
The Geriatric Depression Scale (GDS) is scored from 0 to 15. Scores of 0-4 are considered normal, 5-8 indicate mild depression; 9-11 indicate moderate depression; and 12-15 indicate severe depression.
Measured: Up tp 2 years
Pittsburgh Sleep Quality Index (PSQI)
The Pittsburgh Sleep Quality Index (PSQI) is scored from 0 to 21. Higher scores indicate worse sleep quality.
Measured: Up to 2 years
Leisure-Time Activities Questionnaire
The Leisure-Time Activities Questionnaire measures the frequency of engagement in the following activities: Health activities, Social activities, Productive activities, Fitness activities, Recreational activities, Any cognitively-stimulating activities. Scores are measured on a 3-point scale. Higher scores represent higher frequency of engagement in leisure-time activities.
Measured: Up to 2 years
Resource Use Inventory (RUI)
The Resource Use Inventory (RUI) measures 4 domains: direct medical care, direct nonmedical care, informal care, and subjects' time use. The RUI is filled in based on the frequency and amount of resources used. If none were used, '00' is entered.
Measured: Up to 2 years
Hight
Height will be measured in metres
Measured: Up to 2 years
Weight
Weight will be measured in kilograms.
Measured: Up to 2 years
Hip circumference
Hip circumference will be measured in centimetres.
Measured: Up to 2 years
Waist circumference
Waist circumference will be measured in centimetres.
Measured: Up to 2 years
Changes in Blood Pressure
Vascular and metabolic risk factors measured by changes in blood pressure in mmHg. Incident events using serious adverse event reports will also be assessed.
Measured: Up to 2 years
Changes in lipid Profile
Blood samples will be collected from all patients in tubes with ethylenediaminetetraacetic acid 0.1%. Lipid Profile will be expressed by total cholesterol, LDL-cholesterol, HDL-cholesterol or triglycerides in mmol/L.
Measured: Up to 2 years
Changes in Glucose Regulation
Vascular and metabolic risk factors measured by changes in glucose regulation in mmol/L.
Measured: Up to 2 years
Retinal Imaging Markers
Retinal fundus photographs will be taken of each eye with a nonmydriatic digital camera after dilation of pupils with 1% tropicamide eye drops. A semi-automated computer-assisted program will be used to assess retinal vascular fractal dimensions (among other parameters such as vessel caliber and vessel tortuosity) from optic disc-centered images of a randomly selected eye per participant.
Measured: Up to 2 years
Falls
Prospective rate of falls, causes and consequences via monthly calendar will be recorded.
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2023
- Study start28 May 2023 (estimated)
- Primary completion28 Apr 2025 (estimated)
- Study completion28 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Cognitive ImpairmentStudies of the same condition, open and under way.
- More trials run by Zhejiang UniversityThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xin Xu, Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05886114
- Sponsor's protocol ID
- 31005808A111272274170
- Acronym
- HERITAGE
- Status last verified
- Jun 2023
- First submitted
- 8 May 2023
- Last updated
- 6 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Interested collaborators may put in a request.
Publications
Xu X, Chew KA, Wong ZX, Phua AKS, Chong EJY, Teo CKL, Sathe N, Chooi YC, Chia WPF, Henry CJ, Chew E, Wang M, Maier AB, Kandiah N, Chen CL. The SINgapore GERiatric Intervention Study to Reduce Cognitive Decline and Physical Frailty (SINGER): Study Design and Protocol. J Prev Alzheimers Dis. 2022;9(1):40-48. doi: 10.14283/jpad.2022.5.
PubMed 35098972Zhao X, Hu R, Wen H, Xu G, Pang T, He X, Zhang Y, Zhang J, Chen C, Wu X, Xu X. A voice recognition-based digital cognitive screener for dementia detection in the community: Development and validation study. Front Psychiatry. 2022 Jul 22;13:899729. doi: 10.3389/fpsyt.2022.899729. eCollection 2022.
PubMed 35935417Xu X, Pang T, Zhou Y, Zhang H, Ma A, Yuan C, Chen H, Wen X, Yang Q, Xu X. The Multi-domain Lifestyle Intervention for Cognitive Impairment in Community-Dwelling Older Adults in Hangzhou (The Heritage Study): Study Design and Protocol. J Prev Alzheimers Dis. 2024;11(3):601-611. doi: 10.14283/jpad.2024.59.
PubMed 38706276
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-domain Lifestyle Intervention Among Aged Community-residents in Zhejiang, China
- ClinicalTrials.gov ID
- NCT05886114
- Acronym / sponsor ID
- HERITAGE / 31005808A111272274170
- Conditions
- Cognitive Impairment, Alzheimer Disease, Vascular Cognitive Impairment, Dement, Brain Diseases, Central Nervous System Diseases
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- Zhejiang UniversityUniversity, hospital or other
- Study start
- 28 May 2023 (estimated)
- Primary completion
- 28 Apr 2025 (estimated)
- Study completion
- 28 Apr 2027 (estimated)
- First posted
- 2 Jun 2023 (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.
A study conducted in Finland discovered that a multidomain intervention, consisting of physical activity, nutritional guidance, cognitive training, social activities, and management of vascular risk factors, effectively decelerated cognitive decline in healthy older adults who were at an increased risk of cognitive decline. The HERITAGE study is a 2-year clustered randomized controlled trial (clustered-RCT) that explores the efficacy of a multidomain intervention among 1200 elderly residents with a higher risk of cognitive decline and dementia in Zhejiang Province, China
Detailed description
The effectiveness of a multidomain lifestyle intervention on the prevention of cognitive decline and dementia have not been studied in Asian elderly at high risk of dementia conversion. Dementia is caused by both nonmodifiable genetic variables, and modifiable lifestyle risk factors. While neuroimaging biomarkers have been well documented in the neurophysiology of ageing and age-associated cognitive decline, their role as surrogate endpoints and intermediate variables between multi-domain lifestyle intervention and cognitive benefits has not been studied. The current study aims to understand brain functional and structural changes that may result from a multi-domain lifestyle intervention and whether the changes correlate with improvement in cognitive function. At risk elderly aged 60-80 years will be randomly allocated to either the control arm (self-guided management) or the intervention (multi-domain lifestyle) arm, which consists of nutritional guidance, physical exercise, cognitive training and the monitoring and management of vascular and metabolic risk factors. We hypothesize that the multi-domain lifestyle intervention will promote favorable changes in cognitive function. Moreover, such intervention will slow down the progression of cerebrovascular disease and neurodegeneration in participants in the intervention arm. Findings from the present study will shed light on the biological mechanisms of age-related cognitive decline and neurodegenerative disease. Insight obtained from the study could be translated into new targets of nonpharmacological interventions which aim at the potential causal molecular pathways implicated in ageing and age-related cognitive decline. Adaption and implementation of our findings into clinical and public health practice will further promote healthy and confident ageing among Chinese elderly, to eventually expand their health span.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Structured Multi-domain Intervention | Experimental | Behavioral: Structured Multi-domain InterventionMulti-domain structured intervention will be tailored by Chinese traditional and social norms and then conducted among the intervention group. That includes: Nutritional and dietary instruction, Cognitive training, Physical exercises, and Vascular risks monitoring and control. |
| Self-Guided Intervention | Experimental | Behavioral: Self-Guided InterventionEvery 6-12 months, control group will receive a regular health education campaign to encourage a healthy lifestyle and a regular health monitoring and examination of blood pressure, weight, fasting blood glucose and liposome group |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- At risk of cognitive decline: cognitive performance at the mean level or slightly lower than expected for age with no dementia (AD8>=3 and/or 5-min MoCA >, < 11)
- Free of physical disabilities that preclude participation in the study
- Willing to complete all study-related activities for 24 months
- Willing to be randomized to either lifestyle intervention group
Key exclusion criteria (6 listed)
- Diagnosed dementia patients
- Diagnosed major depression or other neuropsychological diseases
- Malignant diseases
- Symptomatic cardiovascular disease
- Revascularization within one year
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 |
|---|---|---|
| Structured Multi-domain InterventionAlso: SMIStructured Multi-domain Intervention (SMI) involves providing participants with intensive structure and support by a team of trainers to increase physical exercise, adhere to a healthy diet, cognitive training, increase intellectual/social stimulation, and better manage vascular risk factors. | Behavioural | Structured Multi-domain Intervention |
| Self-Guided InterventionAlso: SGIIn the Self-Guided Intervention (SGI), education about the importance of a healthy lifestyle as a preventive strategy and support to encourage change will be provided. | Behavioural | Self-Guided Intervention |
Primary outcome
Global Cognition
Time frame: Up to 2 years
Globe cognitive performance (composite z-score) measured by comprehensive Neuropsychological Test Battery (NTB)
Domain-specific Cognition
Time frame: Up to 2 years
NTB domain-specific cognitive performance (composite z-score) for memory, executive function, attention, language, visuomotor speed and visuoconstruction.
27 secondary outcomes
Neuroimaging: MRA
Time frame: Up to 2 years
Neuroimaging: MRI
Time frame: Up to 2 years
Neuroimaging: fMRI
Time frame: Up to 2 years
Number of participants with Laboratory Values /Blood markers
Time frame: Up to 2 years
Incident dementia
Time frame: Up to 2 years
Clinical Dementia Rating-Sum of Boxes (CDR-SB)
Time frame: Up to 2 years
Alzheimer's Disease Cooperative Study Activities of Daily Living Mild Cognitive Impairment-Activities of Daily Living Inventory (ADCS MCI-ADL)
Time frame: Up to 2 years
Cardiovascular morbidity
Time frame: Up to 2 years
Physical Performance: Grip strength
Time frame: Up to 2 years
Physical Performance: Gaid speed
Time frame: Up to 2 years
Physical Performance: Balance
Time frame: Up to 2 years
Physical Performance: Endurance
Time frame: Up to 2 years
Physical Performance: Lower limb strength
Time frame: Up to 2 years
Quality of Life Questionnaire (15D)
Time frame: Up to 2 years
The Geriatric Depression Scale (GDS)
Time frame: Up tp 2 years
Pittsburgh Sleep Quality Index (PSQI)
Time frame: Up to 2 years
Leisure-Time Activities Questionnaire
Time frame: Up to 2 years
Resource Use Inventory (RUI)
Time frame: Up to 2 years
Hight
Time frame: Up to 2 years
Weight
Time frame: Up to 2 years
Hip circumference
Time frame: Up to 2 years
Waist circumference
Time frame: Up to 2 years
Changes in Blood Pressure
Time frame: Up to 2 years
Changes in lipid Profile
Time frame: Up to 2 years
Changes in Glucose Regulation
Time frame: Up to 2 years
Retinal Imaging Markers
Time frame: Up to 2 years
Falls
Time frame: Up to 2 years
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 6 Jun 2023.
- Background: PubMed 35098972Xu X, Chew KA, Wong ZX, Phua AKS, Chong EJY, Teo CKL, Sathe N, Chooi YC, Chia WPF, Henry CJ, Chew E, Wang M, Maier AB, Kandiah N, Chen CL. The SINgapore GERiatric Intervention Study to Reduce Cognitive Decline and Physical Frailty (SINGER): Study Design and Protocol. J Prev Alzheimers Dis. 2022;9(1):40-48. doi: 10.14283/jpad.2022.5.
- Results publication: PubMed 35935417Zhao X, Hu R, Wen H, Xu G, Pang T, He X, Zhang Y, Zhang J, Chen C, Wu X, Xu X. A voice recognition-based digital cognitive screener for dementia detection in the community: Development and validation study. Front Psychiatry. 2022 Jul 22;13:899729. doi: 10.3389/fpsyt.2022.899729. eCollection 2022.
- Derived from this study: PubMed 38706276Xu X, Pang T, Zhou Y, Zhang H, Ma A, Yuan C, Chen H, Wen X, Yang Q, Xu X. The Multi-domain Lifestyle Intervention for Cognitive Impairment in Community-Dwelling Older Adults in Hangzhou (The Heritage Study): Study Design and Protocol. J Prev Alzheimers Dis. 2024;11(3):601-611. doi: 10.14283/jpad.2024.59.
- Individual participant dataSharing planned: No. Interested collaborators may put in a request.
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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.
Changzheng Yuan, PhD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Structured Multi-domain Intervention and Self-Guided Intervention in people with Cognitive Impairment and Alzheimer Disease, run by Zhejiang 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 4 inclusion and 6 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 6 Jun 2023. 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 Xin Xu, PhD (+8613575760802, xuxinsummer@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Global Cognition (time frame: Up to 2 years). 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?
On the ClinicalTrials.gov record for NCT05886114, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2023.