Cognitive ImpairmentNCT04465812
The Impact of a Smartphone-based Personalized Intervention on Cognitive and Cerebrovascular Health in CIRCLE-CHINA
A study testing Self-monitoring and personalized feedback on smartphone app in people with Cognitive Impairment and Stroke, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
This smartphone-based personalized multiple intervention study aims to prevent cognitive impairment and reduce dementia and cerebrovascular events in 45-74 year old persons with high risk of stroke in China. Read more about this study
- Who is it for?
- Ages 45 to 74 yearsHealthy volunteers can take part
- Conditions the study is for
- Cognitive Impairment, Stroke, Dementia
- What is being tested?
- Self-monitoring and personalized feedback on smartphone app
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 238 participants
- Where
- 1 siteChina
- Study dates
- 21 Jul 2020to 31 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 45 to 74 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- aged 45-74 years
- high risk of stroke (with ≥ 3 of 8 stroke risk factors, including hypertension, dyslipidemia, diabetes, atrial fibrillation or valvular heart disease, smoking history, obvious overweight or obesity, lack of exercise, family history of stroke, or with transient ischemic attack)
Who cannot join
- previously diagnosed dementia
- previously diagnosed stroke (both cerebral infarction and hemorrhage)
- suspected dementia after clinical assessment by study physician at screening visit
- disorders affecting safe engagement in the intervention (eg, malignant disease, major depression, symptomatic cardiovascular disease, revascularisation within 1 year previously)
- severe loss of vision, hearing, or communicative ability;
- disorders preventing cooperation as judged by the study physician
- coincident participation in another intervention trial
- any MRI contraindications
Trial locations and contacts
1 site in 1 country.
China1 site
Second Affilated Hospital of Zhejiang University, School of Medicine
Hangzhou, Zhejiang, 310009
About this study
Official title: The Impact of a Smartphone-based Self-monitoring and Personalized Feedback Multiple Intervention on Cognitive and Cerebrovascular Health in CIRCLE-CHINA
This smartphone-based personalized multiple intervention study aims to prevent cognitive impairment and reduce dementia and cerebrovascular events in 45-74 year old persons with high risk of stroke in China. The investigators plan to monitor and manage participants' behavioral and health (vascular risk factors control, sleep quality, mental health and cognitive training) based on self-monitoring and personalized feedback via smartphone app. The short-term primary outcome is 1-year change in global cognitive score measured by a modified National Institute of Neurological Disorders and Stroke and Canadian Stroke Network-Canadian Stroke Network protocol. The investigators hypothesize that the intervention based on self-monitoring and personalized feedback will prevent cognitive decline by the initial 1-year intervention. The long-term primary outcome is the development of dementia and cerebrovascular events during a total of 5 years' follow-up. The investigators hypothesize that the smartphone-based personalized multiple intervention may reduce the 5-year risk of dementia and cerebrovascular events, mainly through the improvement in vascular risk factors control, sleep quality, mental health and cognitive training activities.
Read the detailed description
Patients with ≥ 3 stroke risk factors (including hypertension, dyslipidemia, diabetes, atrial fibrillation or valvular heart disease, smoking history, obvious overweight or obesity, lack of exercise, family history of stroke), or with transient ischemic attack, are regarded as patients with high risk of stroke. Studies have indicated that these stroke risk factors might be associated with an increased risk of cerebral small vessel disease (CSVD) progress, glymphatic dysfunction, cognitive decline, dementia, and cerebrovascular events. However, prevention in these patients is largely unknown and the management of these patients is a very troublesome issue. Previous study has demonstrated that interventions in the feedback and monitoring method could improve exercise adherence in older people compared with other methods including comparison of behavior, social support, natural consequences, identity and goals and planning. Therefore, the investigators plan to monitor and manage vascular risk factors control, sleep quality, mental health and cognitive training based on self-monitoring and personalized feedback on a smartphone app in patients with high risk of stroke. The investigators hypothesize that the intervention based on self-monitoring and personalized feedback will reduce cognitive impairment, glymphatic dysfunction, CSVD progress, depressive symptoms, anxious symptoms, improve sleep quality, and reduce dementia and cerebrovascular events incidence in the study group compared to the control group.
- Conditions
- Cognitive Impairment, Stroke, Dementia
- Being tested
- Self-monitoring and personalized feedback on smartphone app
- Medical subject headings
- Cognitive Dysfunction, Stroke, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-monitoring and personalized feedback on smartphone appBehavioural
- Patients will record their blood pressure (once 1-week for patients with hypertension, every 3-month for those without), blood glucose (once 1-month for patients with diabetes), serum lipid metabolism (every 3-month for patients with dyslipidemia) on app, and medical staff will suggest continuing monitoring and recording or recommend outpatient visit;
- Patients will complete Pittsburgh sleep quality index test on app every 3-month, and medical staff will contact with patients with index > 15 to assess detail clinical status and recommend outpatient visit if necessary;
- Patients will complete Self-Rating Anxiety Scale (SAS) and Self-Rating Depression Scale (SDS) on app every 3-month, and medical staff will contact with patients with SAS>49 or SDS>52 to assess detail clinical status and recommend outpatient visit if necessary;
- Patients will complete cognitive training games every week on app;
- Medical staff will send health information on app
| Study group | Role | What they receive |
|---|---|---|
| Standard health counseling at baseline | No intervention | Standard health counseling at baseline |
| Self-monitoring and personalized feedback on smartphone app | Experimental | 1. Patients will record their blood pressure (once 1-week for patients with hypertension, every 3-month for those without), blood glucose (once 1-month for patients with diabetes), serum lipid metabolism (every 3-month for patients with dyslipidemia) on app, and medical staff will suggest continuing monitoring and recording or recommend outpatient visit;
2. Patients will complete Pittsburgh sleep quality index test on app every 3-month, and medical staff will contact with patients with index > 15 to assess detail clinical status and recommend outpatient visit if necessary;
3. Patients will complete Self-Rating Anxiety Scale (SAS) and Self-Rating Depression Scale (SDS) on app every 3-month, and medical staff will contact with patients with SAS>49 or SDS>52 to assess detail clinical status and recommend outpatient visit if necessary;
4. Patients will complete cognitive training games every week on app;
5. Medical staff will send health information on app Receives: Behavioral: Self-monitoring and personalized feedback on smartphone app |
What is being measured
The primary outcome is the main question the study is designed to answer.
Global cognitive function change assessed with Z-score of a modified National Institute of Neurological Disorders and Stroke and Canadian Stroke Network-Canadian Stroke Network protocol
Primary Outcome
Measured: 1 year
Secondary outcomes (27)
The change of cognitive score for each domain of NINDS-CSN battery from baseline to 12-month（attention, executive, Language, visuomotor speed, visuospatial function, memory）
Short-term Secondary Outcome
Measured: 1year
Cognitive function change assessed by scores of Mini-Mental State Examination (MMSE) (minimum value = 0, maximum value = 30, and higher scores mean a better outcome)
Short-term Secondary Outcome
Measured: 1 year
Cognitive function change assessed by scores of Montreal Cognitive Assessment (MoCA) (minimum value = 0, maximum value = 30, and higher scores mean a better outcome)
Short-term Secondary Outcome
Measured: 1 year
Dementia and cerebrovascular events incidence
Short-term Secondary Outcome
Measured: 1 year
Changes in glymphatic function assessed by dispersion coefficient of periarterial and perivenous spaces on DTI
Short-term Secondary Outcome
Measured: 1 year
Changes in image markers (WMHs, lacunes, microbleeds, perivascular spaces, brain atrophy, micro-infarcts) of CSVD assessed on MRI
Short-term Secondary Outcome
Measured: 1 year
Dementia and cerebrovascular events incidence
Long-term Secondary Outcome
Measured: 5 years
Depressive symptoms assessed by scores of Hamilton depression scale (HAMD) (minimum value = 0, maximum value = 77, and higher scores mean a worse outcome)
Short-term Secondary Outcome
Measured: 1 year
Depressive symptoms assessed by scores of Hamilton anxiety scale (HAMA) (minimum value = 0, maximum value = 56, and higher scores mean a worse outcome)
Short-term Secondary Outcome
Measured: 1 year
Sleep quality assessed by Pittsburgh sleep quality index (minimum value = 0, maximum value = 21, and higher scores mean a worse outcome)
Short-term Secondary Outcome
Measured: 1 year
Global cognitive function change assessed with Z-score of a modified National Institute of Neurological Disorders and Stroke and Canadian Stroke Network-Canadian Stroke Network protocol
Long-term Secondary Outcome
Measured: 5 years
Cognitive function change assessed by scores of Mini-Mental State Examination (MMSE) (minimum value = 0, maximum value = 30, and higher scores mean a better outcome)
Long-term Secondary Outcome
Measured: 5 years
Cognitive function change assessed by scores of Montreal Cognitive Assessment (MoCA) (minimum value = 0, maximum value = 30, and higher scores mean a better outcome)
Long-term Secondary Outcome
Measured: 5 years
Changes in image markers (WMHs, lacunes, microbleeds, perivascular spaces, brain atrophy, micro-infarcts) of CSVD assessed on MRI
Long-term Secondary Outcome
Measured: 5 years
Changes in glymphatic function assessed by dispersion coefficient of periarterial and perivenous spaces on DTI
Long-term Secondary Outcome
Measured: 5 years
Depressive symptoms assessed by scores of Hamilton depression scale (HAMD) (minimum value = 0, maximum value = 77, and higher scores mean a worse outcome)
Long-term Secondary Outcome
Measured: 5 years
Depressive symptoms assessed by scores of Hamilton anxiety scale (HAMA) (minimum value = 0, maximum value = 56, and higher scores mean a worse outcome)
Long-term Secondary Outcome
Measured: 5 years
Sleep quality assessed by Pittsburgh sleep quality index (minimum value = 0, maximum value = 21, and higher scores mean a worse outcome)
Long-term Secondary Outcome
Measured: 5 years
Global cognitive function change assessed with Z-score of a modified National Institute of Neurological Disorders and Stroke and Canadian Stroke Network-Canadian Stroke Network protocol
Long-term Secondary Outcome
Measured: 2 years
Dementia and cerebrovascular events incidence
Long-term Secondary Outcome
Measured: 2 years
Cognitive function change assessed by scores of Mini-Mental State Examination (MMSE) (minimum value = 0, maximum value = 30, and higher scores mean a better outcome)
Long-term Secondary Outcome
Measured: 2 years
Cognitive function change assessed by scores of Montreal Cognitive Assessment (MoCA) (minimum value = 0, maximum value = 30, and higher scores mean a better outcome)
Long-term Secondary Outcome
Measured: 2 years
Changes in image markers (WMHs, lacunes, microbleeds, perivascular spaces, brain atrophy, micro-infarcts) of CSVD assessed on MRI
Long-term Secondary Outcome
Measured: 2 years
Changes in glymphatic function assessed by dispersion coefficient of periarterial and perivenous spaces on DTI
Long-term Secondary Outcome
Measured: 2 years
Depressive symptoms assessed by scores of Hamilton depression scale (HAMD) (minimum value = 0, maximum value = 77, and higher scores mean a worse outcome)
Long-term Secondary Outcome
Measured: 2 years
Depressive symptoms assessed by scores of Hamilton anxiety scale (HAMA) (minimum value = 0, maximum value = 56, and higher scores mean a worse outcome)
Long-term Secondary Outcome
Measured: 2 years
Sleep quality assessed by Pittsburgh sleep quality index (minimum value = 0, maximum value = 21, and higher scores mean a worse outcome)
Long-term Secondary Outcome
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2020
- Study start21 Jul 2020
- Primary completion5 Aug 2021
- Study completion31 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive ImpairmentStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 238 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Shaoxing Gaobu Street Community Health Service Center, Shaoxing Mashan Street Community Health Service Center, Shaoxing Doumen Street Community Health Service Center
- Responsible party
- Principal investigator, Min Lou, Second Affiliated Hospital, Zhejiang University, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04465812
- Sponsor's protocol ID
- CIRCLE-CHINA II
- Status last verified
- Jan 2024
- First submitted
- 28 Jun 2020
- Last updated
- 15 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of a Smartphone-based Self-monitoring and Personalized Feedback Multiple Intervention on Cognitive and Cerebrovascular Health in CIRCLE-CHINA
- ClinicalTrials.gov ID
- NCT04465812
- Acronym / sponsor ID
- CIRCLE-CHINA II
- Conditions
- Cognitive Impairment, Stroke, Dementia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 238 participants (actual)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Collaborators
- Shaoxing Gaobu Street Community Health Service Center, Shaoxing Mashan Street Community Health Service Center, Shaoxing Doumen Street Community Health Service Center
- Study start
- 21 Jul 2020 (actual)
- Primary completion
- 5 Aug 2021 (actual)
- Study completion
- 31 May 2025 (actual)
- First posted
- 10 Jul 2020 (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 smartphone-based personalized multiple intervention study aims to prevent cognitive impairment and reduce dementia and cerebrovascular events in 45-74 year old persons with high risk of stroke in China. The investigators plan to monitor and manage participants' behavioral and health (vascular risk factors control, sleep quality, mental health and cognitive training) based on self-monitoring and personalized feedback via smartphone app. The short-term primary outcome is 1-year change in global cognitive score measured by a modified National Institute of Neurological Disorders and Stroke and Canadian Stroke Network-Canadian Stroke Network protocol. The investigators hypothesize that the intervention based on self-monitoring and personalized feedback will prevent cognitive decline by the initial 1-year intervention. The long-term primary outcome is the development of dementia and cerebrovascular events during a total of 5 years' follow-up. The investigators hypothesize that the smartphone-based personalized multiple intervention may reduce the 5-year risk of dementia and cerebrovascular events, mainly through the improvement in vascular risk factors control, sleep quality, mental health and cognitive training activities.
Detailed description
Patients with ≥ 3 stroke risk factors (including hypertension, dyslipidemia, diabetes, atrial fibrillation or valvular heart disease, smoking history, obvious overweight or obesity, lack of exercise, family history of stroke), or with transient ischemic attack, are regarded as patients with high risk of stroke. Studies have indicated that these stroke risk factors might be associated with an increased risk of cerebral small vessel disease (CSVD) progress, glymphatic dysfunction, cognitive decline, dementia, and cerebrovascular events. However, prevention in these patients is largely unknown and the management of these patients is a very troublesome issue. Previous study has demonstrated that interventions in the feedback and monitoring method could improve exercise adherence in older people compared with other methods including comparison of behavior, social support, natural consequences, identity and goals and planning. Therefore, the investigators plan to monitor and manage vascular risk factors control, sleep quality, mental health and cognitive training based on self-monitoring and personalized feedback on a smartphone app in patients with high risk of stroke. The investigators hypothesize that the intervention based on self-monitoring and personalized feedback will reduce cognitive impairment, glymphatic dysfunction, CSVD progress, depressive symptoms, anxious symptoms, improve sleep quality, and reduce dementia and cerebrovascular events incidence in the study group compared to the control group.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard health counseling at baseline | No intervention | –Standard health counseling at baseline |
| Self-monitoring and personalized feedback on smartphone app | Experimental | Behavioral: Self-monitoring and personalized feedback on smartphone app1. Patients will record their blood pressure (once 1-week for patients with hypertension, every 3-month for those without), blood glucose (once 1-month for patients with diabetes), serum lipid metabolism (every 3-month for patients with dyslipidemia) on app, and medical staff will suggest continuing monitoring and recording or recommend outpatient visit; 2. Patients will complete Pittsburgh sleep quality index test on app every 3-month, and medical staff will contact with patients with index > 15 to assess detail clinical status and recommend outpatient visit if necessary; 3. Patients will complete Self-Rating Anxiety Scale (SAS) and Self-Rating Depression Scale (SDS) on app every 3-month, and medical staff will contact with patients with SAS>49 or SDS>52 to assess detail clinical status and recommend outpatient visit if necessary; 4. Patients will complete cognitive training games every week on app; 5. Medical staff will send health information on app |
Who may qualify
- Ages
- 45 to 74 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- aged 45-74 years
- high risk of stroke (with ≥ 3 of 8 stroke risk factors, including hypertension, dyslipidemia, diabetes, atrial fibrillation or valvular heart disease, smoking history, obvious overweight or obesity, lack of exercise, family history of stroke, or with transient ischemic attack)
Key exclusion criteria (8 listed)
- previously diagnosed dementia
- previously diagnosed stroke (both cerebral infarction and hemorrhage)
- suspected dementia after clinical assessment by study physician at screening visit
- disorders affecting safe engagement in the intervention (eg, malignant disease, major depression, symptomatic cardiovascular disease, revascularisation within 1 year previously)
- severe loss of vision, hearing, or communicative ability;
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 |
|---|---|---|
| Self-monitoring and personalized feedback on smartphone app1. Patients will record their blood pressure (once 1-week for patients with hypertension, every 3-month for those without), blood glucose (once 1-month for patients with diabetes), serum lipid metabolism (every 3-month for patients with dyslipidemia) on app, and medical staff will suggest continuing monitoring and recording or recommend outpatient visit; 2. Patients will complete Pittsburgh sleep quality index test on app every 3-month, and medical staff will contact with patients with index > 15 to assess detail clinical status and recommend outpatient visit if necessary; 3. Patients will complete Self-Rating Anxiety Scale (SAS) and Self-Rating Depression Scale (SDS) on app every 3-month, and medical staff will contact with patients with SAS>49 or SDS>52 to assess detail clinical status and recommend outpatient visit if necessary; 4. Patients will complete cognitive training games every week on app; 5. Medical staff will send health information on app | Behavioural | Self-monitoring and personalized feedback on smartphone app |
Primary outcome
Global cognitive function change assessed with Z-score of a modified National Institute of Neurological Disorders and Stroke and Canadian Stroke Network-Canadian Stroke Network protocol
Time frame: 1 year
Primary Outcome
27 secondary outcomes
The change of cognitive score for each domain of NINDS-CSN battery from baseline to 12-month（attention, executive, Language, visuomotor speed, visuospatial function, memory）
Time frame: 1year
Cognitive function change assessed by scores of Mini-Mental State Examination (MMSE) (minimum value = 0, maximum value = 30, and higher scores mean a better outcome)
Time frame: 1 year
Cognitive function change assessed by scores of Montreal Cognitive Assessment (MoCA) (minimum value = 0, maximum value = 30, and higher scores mean a better outcome)
Time frame: 1 year
Dementia and cerebrovascular events incidence
Time frame: 1 year
Changes in glymphatic function assessed by dispersion coefficient of periarterial and perivenous spaces on DTI
Time frame: 1 year
Changes in image markers (WMHs, lacunes, microbleeds, perivascular spaces, brain atrophy, micro-infarcts) of CSVD assessed on MRI
Time frame: 1 year
Dementia and cerebrovascular events incidence
Time frame: 5 years
Depressive symptoms assessed by scores of Hamilton depression scale (HAMD) (minimum value = 0, maximum value = 77, and higher scores mean a worse outcome)
Time frame: 1 year
Depressive symptoms assessed by scores of Hamilton anxiety scale (HAMA) (minimum value = 0, maximum value = 56, and higher scores mean a worse outcome)
Time frame: 1 year
Sleep quality assessed by Pittsburgh sleep quality index (minimum value = 0, maximum value = 21, and higher scores mean a worse outcome)
Time frame: 1 year
Global cognitive function change assessed with Z-score of a modified National Institute of Neurological Disorders and Stroke and Canadian Stroke Network-Canadian Stroke Network protocol
Time frame: 5 years
Cognitive function change assessed by scores of Mini-Mental State Examination (MMSE) (minimum value = 0, maximum value = 30, and higher scores mean a better outcome)
Time frame: 5 years
Cognitive function change assessed by scores of Montreal Cognitive Assessment (MoCA) (minimum value = 0, maximum value = 30, and higher scores mean a better outcome)
Time frame: 5 years
Changes in image markers (WMHs, lacunes, microbleeds, perivascular spaces, brain atrophy, micro-infarcts) of CSVD assessed on MRI
Time frame: 5 years
Changes in glymphatic function assessed by dispersion coefficient of periarterial and perivenous spaces on DTI
Time frame: 5 years
Depressive symptoms assessed by scores of Hamilton depression scale (HAMD) (minimum value = 0, maximum value = 77, and higher scores mean a worse outcome)
Time frame: 5 years
Depressive symptoms assessed by scores of Hamilton anxiety scale (HAMA) (minimum value = 0, maximum value = 56, and higher scores mean a worse outcome)
Time frame: 5 years
Sleep quality assessed by Pittsburgh sleep quality index (minimum value = 0, maximum value = 21, and higher scores mean a worse outcome)
Time frame: 5 years
Global cognitive function change assessed with Z-score of a modified National Institute of Neurological Disorders and Stroke and Canadian Stroke Network-Canadian Stroke Network protocol
Time frame: 2 years
Dementia and cerebrovascular events incidence
Time frame: 2 years
Cognitive function change assessed by scores of Mini-Mental State Examination (MMSE) (minimum value = 0, maximum value = 30, and higher scores mean a better outcome)
Time frame: 2 years
Cognitive function change assessed by scores of Montreal Cognitive Assessment (MoCA) (minimum value = 0, maximum value = 30, and higher scores mean a better outcome)
Time frame: 2 years
Changes in image markers (WMHs, lacunes, microbleeds, perivascular spaces, brain atrophy, micro-infarcts) of CSVD assessed on MRI
Time frame: 2 years
Changes in glymphatic function assessed by dispersion coefficient of periarterial and perivenous spaces on DTI
Time frame: 2 years
Depressive symptoms assessed by scores of Hamilton depression scale (HAMD) (minimum value = 0, maximum value = 77, and higher scores mean a worse outcome)
Time frame: 2 years
Depressive symptoms assessed by scores of Hamilton anxiety scale (HAMA) (minimum value = 0, maximum value = 56, and higher scores mean a worse outcome)
Time frame: 2 years
Sleep quality assessed by Pittsburgh sleep quality index (minimum value = 0, maximum value = 21, and higher scores mean a worse outcome)
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Cognitive Impairment
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
Recruiting
HEARS-NPS: Addressing Hearing Loss as a Common Unmet Contributor of Neuropsychiatric Symptoms
Alzheimer Disease, Dementia
RecruitingObservational study
Locus Coeruleus and CCHS (Congenital Central Hypoventilation Syndrome)
Ondine Syndrome (Congenital Central Hypoventilation Syndrome)
RecruitingPhase 1
PET Imaging of Phosphodiesterase-4 (PDE4) in Volunteers With Alzheimer Disease (AD) or Mild Cognitive Impairment (MCI)
Alzheimer s Disease, Mild Cognitive Impairment
RecruitingObservational study
Community-based Screening for Alzheimer's Disease
Alzheimer's Disease(AD), Mild Cognitive Impairment (MCI)
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-monitoring and personalized feedback on smartphone app in people with Cognitive Impairment and Stroke, run by Second Affiliated Hospital, Zhejiang University, School of Medicine 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 2 inclusion and 8 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: finished, as of the sponsor's last update on 15 Jun 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Global cognitive function change assessed with Z-score of a modified National Institute of Neurological Disorders and Stroke and Canadian Stroke Network-Canadian Stroke Network protocol (time frame: 1 year). 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 15 Jun 2025.