Mild Cognitive ImpairmentTIMENCT05310890
Long Term Prospective Study of Tai Chi Intervention to Prevent MCI From Conversion to Dementia
A study testing Tai chi training and Group activity in people with Mild Cognitive Impairment, run by Ruijin Hospital.
Trial summary
This study evaluates the effects of 3 years-Tai Chi exercise intervention on cognitive function in MCI patients and to clarify whether the intervention can prevent MCI from conversion to dementia. Patients will be randomized into the Tai chi training group and the control group. Read more about this study
- Who is it for?
- Ages 55 to 75 years
- Conditions the study is for
- Mild Cognitive Impairment
- What is being tested?
- Tai chi training and Group activity
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 206 participants
- Where
- No sites listed yet
- Study dates
- Sep 2022to Sep 2026
- 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 55 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female participants aged 55 to 85 years (inclusive) at the time of screening
- Willing and able to give informed consent by GCP and local guidance.
- Meets the National Institute on Aging of the National Institutes of Health and Alzheimer's Association (NIA-AA) diagnostic criteria for "Mild Cognitive Impairment Due to Alzheimer's Disease" (2011); does not meet the American Psychiatric Association's diagnostic criteria Diagnostic and Statistical Manual of Mental Disorders, Revised IV (DSM-IV-R) diagnostic criteria for dementia;
- Main complaint of memory loss, 24≤MMSE and/or 17≤MOCA<26 points, with one or more cognitive domains impairments;
- CDR global score of 0.5, with memory box score ≥0.5
- Functional activities questionnaire (FAQ) <5
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- Hachinski ischemia score ≤4;
- Have the physical, cognitive, listening, speech, literacy and language skills necessary to participate in all tests;
- Capable of performing MR
- Allowed and Prohibited concomitant and treatments.
- During the clinical study, the following drugs are prohibited:
- Acetylcholinesterase inhibitors, N-methyl-D-aspartate (NMDA) antagonists (eg, memantine, amantadine, ketamine, and dextromethorphan), adrenal corticosteroids, central nervous system stimulants, traditional Chinese medicine and various medicines that can improve memory or cognition;
- During the clinical study, the following drugs cannot be added:
- Antipsychotics, antidepressants, sedative-hypnotics for sleep (zopiclone, alprazolam, estazolam can be used temporarily if necessary) For long-term use of the above drugs, the dose should be kept as stable as possible during the study.
Who cannot join
- Cognitive impairment caused by other reasons (for example) cerebrovascular disease, central nervous system infection, Creutzfeldt-Jakob disease, Huntington's disease, Parkinson's disease, dementia with Lewy bodies, trauma, other physical and chemical factors (drugs, alcohol, CO, etc.), important physical diseases (hepatic encephalopathy, pulmonary encephalopathy, etc.), brain tumor, endocrine diseases (thyroid disease, parathyroid disease), and vitamin deficiency or any other cause of dementia;
- Abnormal folate, thyroid, and/or vitamin B12 values that cannot be corrected before baseline visit.
- Major structural brain disease as judged by central MRI Diagnostic Imaging Review Team (eg, ischemic infarcts, subdural hematoma, hemorrhage, hydrocephalus, brain tumors, multiple subcortical ischemic lesions. or a single lesion in a critical region [eg, thalamus]). Mild white matter changes without clinical significance and no more than 2 lacunar infarcts are permitted.
- Mental illness determined by Diagnostic and Statistical Manual of Mental Disorders (DSM) V criteria, that is unstable within 12 months, or would interfere with study assessments, including schizophrenia or other psychotic disorders, bipolar disorder, severe depression, or delirium.
- DSM V diagnosis of alcohol or other substance abuse dependence within the last 12 months.
- History or current diagnosis of significant cardiac arrhythmias, myocardial infarction, transient ischemic attack, or cerebrovascular accident, uncompensated congestive heart failure New York Heart Association class III and IV.
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- Major medical illness or unstable medical condition within 6 months of screening that in the opinion of the investigator may interfere with the participant's ability to comply with study procedures and abide by study restrictions, or with the ability to interpret safety data, including any physical disability (eg. blindness. deafness, non-cognitive related speech impairment, sensory or motor dysfunction) that would prevent completion of study procedures or assessments.
- Cancer except:
- History of any cancer that has been in remission (no evidence of recurrence) for > 3 years from the screening
- Participants with basal cell or stage I squamous cell carcinoma of the skin, stable untreated cancer as prostate or meningioma.
- Exercise regularly within 6 months prior to screening.
- Participants are excluded if they
- have participated in any other clinical study within 4 weeks prior to screening visit
- have participated in another Tai chi clinical study at any time
- plan to take part in another clinical study during this study.
- Geriatric Depression Scale-15(GDS-15) total score > 7 at screening
- The researcher estimates that the subject's compliance is poor, and it is believed that the subject is unlikely to complete the study.
Trial locations and contacts
No sites are listed yet.
About this study
This study evaluates the effects of 3 years-Tai Chi exercise intervention on cognitive function in MCI patients and to clarify whether the intervention can prevent MCI from conversion to dementia. Patients will be randomized into the Tai chi training group and the control group.
Read the detailed description
Dementia is a syndrome of impairments of cortical functions caused by brain diseases. More than 55 million people worldwide are currently living with dementia, with nearly 10 million new cases each year. Alzheimer's disease is the most common form of dementia and may account for 60-70% of patients with dementia. Mild cognitive impairment (MCI) is an intermediate state between normal cognitive aging and dementia. About 10% to 15% of patients with MCI progress to dementia each year. Therefore, it is crucial to find intervention strategies to prevent the progression of MCI to dementia. However, drug interventions are currently ineffective in the prevention of dementia. Based on the synaptic plasticity, more and more studies focus on non-drug interventions. Our research group previously found 6-months non-drug interventions (cognitive training, exercise therapy) can effectively delay cognitive decline in the elderly, providing a new strategy for the improvement of cognition in the elderly. Therefore, this project plans to conduct a multi-site, randomized, parallel-controlled clinical trial to examine the effect of 3 years-Tai Chi exercise intervention on cognitive function in MCI patients and to clarify whether the intervention can prevent MCI from conversion to dementia.
- Conditions
- Mild Cognitive Impairment
- Being tested
- Tai chi training, Group activity
- Keywords
- Mild Cognitive Impairment, Tai Chi
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tai chi trainingBehavioural
Tai chi, also called tai chi chuan, is an ancient Chinese form of exercise originally created as a fighting art. It is a kind of gentle physical exercise and stretching, which involves a series of movements performed in a slow, focused manner and accompanied by deep breathing.
Group activityBehavioural
A organizer will lead the subjects to participate in group activities once a quarter. In group activities, there will be popular science lectures and interactive games.
| Study group | Role | What they receive |
|---|---|---|
| Tai chi training plus group activity | Experimental | Tai chi training: a teacher will give two 60-min lessons per week. Participants will play Tai Chi in the lessons, following teacher's instruction.
Group activity: a organizer will lead the subjects to participate in group activities, once per quarter. Receives: Behavioral: Tai chi training; Behavioral: Group activity |
| Only group activity | Other | Group activity: a organizer will lead the subjects to participate in group activities, once per quarter. Receives: Behavioral: Group activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of MCI converted to Alzheimer's disease.
The 3-year incidence of AD in each group will be compared.
Measured: 36 months
The global cognitive function of MCI patients.
11-item Alzheimer's Disease Assessment Scale-Cognitive subscale (ADAS-Cog 11) will be used to assess the global cognitive performance of MCI patients. The total score of ADAS-cog/11 is 0-70, with higher scores mean a worse outcome.
Measured: 18 months and 36 months
Secondary outcomes (17)
Memory
Memory will be assessed using the Auditory verbal learning test-Huashan version (AVLT-H).
Measured: 18 months and 36 months
Attention
Attention will be evaluated by Trial Making Test (TMT).
Measured: 18 months and 36 months
Executive function
Executive function will be evaluated by the Stroop task.
Measured: 18 months and 36 months
Language
Language will be assessed by Boston naming test (30-item version), and Verbal Fluency.
Measured: 18 months and 36 months
Working memory test
Working memory test will be assessed by Number Span Forward and Backward.
Measured: 18 months and 36 months
Visual spatial ability
Visual spatial ability will be assessed by Clock Drawing Test.
Measured: 18 months and 36 months
Change from baseline in MMSE score
Change from baseline in Mini Mental State Examination (MMSE) score. The total score of MMSE is 0-30, with higher scores mean a better outcome.
Measured: 18 months and 36 months
Change from baseline in MoCA score
Change from baseline in Montreal Cognitive Assessment (MoCA) score. The total score of MoCA is 0-30, with higher scores mean a better outcome.
Measured: 18 months and 36 months
Change from baseline in CDR score
Change from baseline in Clinical Dementia Rating (CDR) Scale score.
Measured: 18 months and 36 months
Activities of daily living
Activities of daily living will be assessed by functional activities questionnaire (FAQ). The total score of FAQ is 0-30, with higher scores mean a worse outcome.
Measured: 18 months and 36 months
Anxiety
Anxiety will be assessed by Hamilton Anxiety Rating Scale (HAMA).The total score of HAMA is 0-56, with higher scores mean a worse outcome.
Measured: 18 months and 36 months
Depression
Depression will be assessed by Hamilton Depression Rating Scale (HAMD).
Measured: 18 months and 36 months
Sleep
Sleep will be assessed by Pittsburgh Sleep Quality Index (PSQI).The total score of PSQI is 0-21, with higher scores mean a worse outcome.
Measured: 18 months and 36 months
Brain activity
Detecting changes associated with blood flow by fMRI.
Measured: 36 months
Neurodegeneration in brain structures
Brain atrophy will be assessed by Magnetic Resonance Volume Imaging.
Measured: 36 months
Gut microbiota
Gut microbiota will be assessed by 16S rRNA sequencing.
Measured: 18 months and 36 months
Blood biomarkers
Inflammatory factors (FGF basic、Eotaxin、G-CSF、GM-CSF、IFN-γ、IL-1β、IL-1ra、IL-2、IL-4、IL-5、IL-6、IL-7、IL-8、IL-9、IL-10、IL-12 (p70)、IL-13、IL-15、IL-17、IP-10、MCP-1 (MCAF)、MIP-1α、MIP-1β、PDGF-BB、RANTES、TNF-α、VEGF) will be measured by Bio-Plex Human Cytokine Assays.
Measured: 18 months and 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2022
- Study startSep 2022 (estimated)
- Primary completionSep 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- More trials run by Ruijin 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 206 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Zhangjiagang Aoyang Hospital of Jiangsu Province
- Responsible party
- Principal investigator, Shengdi Chen, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05310890
- Sponsor's protocol ID
- TIME study
- Acronym
- TIME
- Status last verified
- Jul 2022
- First submitted
- 17 Mar 2022
- Last updated
- 1 Aug 2022
- 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 1 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long Term Prospective Study of Tai Chi Intervention to Prevent MCI From Conversion to Dementia
- ClinicalTrials.gov ID
- NCT05310890
- Acronym / sponsor ID
- TIME / TIME study
- Conditions
- Mild Cognitive Impairment
- Keywords
- Mild Cognitive Impairment, Tai Chi
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 206 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Collaborators
- Zhangjiagang Aoyang Hospital of Jiangsu Province
- Study start
- Sep 2022 (estimated)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 5 Apr 2022 (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 study evaluates the effects of 3 years-Tai Chi exercise intervention on cognitive function in MCI patients and to clarify whether the intervention can prevent MCI from conversion to dementia. Patients will be randomized into the Tai chi training group and the control group.
Detailed description
Dementia is a syndrome of impairments of cortical functions caused by brain diseases. More than 55 million people worldwide are currently living with dementia, with nearly 10 million new cases each year. Alzheimer's disease is the most common form of dementia and may account for 60-70% of patients with dementia. Mild cognitive impairment (MCI) is an intermediate state between normal cognitive aging and dementia. About 10% to 15% of patients with MCI progress to dementia each year. Therefore, it is crucial to find intervention strategies to prevent the progression of MCI to dementia. However, drug interventions are currently ineffective in the prevention of dementia. Based on the synaptic plasticity, more and more studies focus on non-drug interventions. Our research group previously found 6-months non-drug interventions (cognitive training, exercise therapy) can effectively delay cognitive decline in the elderly, providing a new strategy for the improvement of cognition in the elderly. Therefore, this project plans to conduct a multi-site, randomized, parallel-controlled clinical trial to examine the effect of 3 years-Tai Chi exercise intervention on cognitive function in MCI patients and to clarify whether the intervention can prevent MCI from conversion to dementia.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tai chi training plus group activity | Experimental | Behavioral: Tai chi training, Behavioral: Group activityTai chi training: a teacher will give two 60-min lessons per week. Participants will play Tai Chi in the lessons, following teacher's instruction. Group activity: a organizer will lead the subjects to participate in group activities, once per quarter. |
| Only group activity | Other | Behavioral: Group activityGroup activity: a organizer will lead the subjects to participate in group activities, once per quarter. |
Who may qualify
- Ages
- 55 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Male and female participants aged 55 to 85 years (inclusive) at the time of screening
- Willing and able to give informed consent by GCP and local guidance.
- Meets the National Institute on Aging of the National Institutes of Health and Alzheimer's Association (NIA-AA) diagnostic criteria for "Mild Cognitive Impairment Due to Alzheimer's Disease" (2011); does not meet the American Psychiatric Association's diagnostic criteria Diagnostic and Statistical Manual of Mental Disorders, Revised IV (DSM-IV-R) diagnostic criteria for dementia;
- Main complaint of memory loss, 24≤MMSE and/or 17≤MOCA<26 points, with one or more cognitive domains impairments;
- CDR global score of 0.5, with memory box score ≥0.5
Key exclusion criteria (17 listed)
- Cognitive impairment caused by other reasons (for example) cerebrovascular disease, central nervous system infection, Creutzfeldt-Jakob disease, Huntington's disease, Parkinson's disease, dementia with Lewy bodies, trauma, other physical and chemical factors (drugs, alcohol, CO, etc.), important physical diseases (hepatic encephalopathy, pulmonary encephalopathy, etc.), brain tumor, endocrine diseases (thyroid disease, parathyroid disease), and vitamin deficiency or any other cause of dementia;
- Abnormal folate, thyroid, and/or vitamin B12 values that cannot be corrected before baseline visit.
- Major structural brain disease as judged by central MRI Diagnostic Imaging Review Team (eg, ischemic infarcts, subdural hematoma, hemorrhage, hydrocephalus, brain tumors, multiple subcortical ischemic lesions. or a single lesion in a critical region [eg, thalamus]). Mild white matter changes without clinical significance and no more than 2 lacunar infarcts are permitted.
- Mental illness determined by Diagnostic and Statistical Manual of Mental Disorders (DSM) V criteria, that is unstable within 12 months, or would interfere with study assessments, including schizophrenia or other psychotic disorders, bipolar disorder, severe depression, or delirium.
- DSM V diagnosis of alcohol or other substance abuse dependence within the last 12 months.
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 |
|---|---|---|
| Tai chi trainingTai chi, also called tai chi chuan, is an ancient Chinese form of exercise originally created as a fighting art. It is a kind of gentle physical exercise and stretching, which involves a series of movements performed in a slow, focused manner and accompanied by deep breathing. | Behavioural | Tai chi training plus group activity |
| Group activityA organizer will lead the subjects to participate in group activities once a quarter. In group activities, there will be popular science lectures and interactive games. | Behavioural | Only group activity, Tai chi training plus group activity |
Primary outcome
Incidence of MCI converted to Alzheimer's disease.
Time frame: 36 months
The 3-year incidence of AD in each group will be compared.
The global cognitive function of MCI patients.
Time frame: 18 months and 36 months
11-item Alzheimer's Disease Assessment Scale-Cognitive subscale (ADAS-Cog 11) will be used to assess the global cognitive performance of MCI patients. The total score of ADAS-cog/11 is 0-70, with higher scores mean a worse outcome.
17 secondary outcomes
Memory
Time frame: 18 months and 36 months
Attention
Time frame: 18 months and 36 months
Executive function
Time frame: 18 months and 36 months
Language
Time frame: 18 months and 36 months
Working memory test
Time frame: 18 months and 36 months
Visual spatial ability
Time frame: 18 months and 36 months
Change from baseline in MMSE score
Time frame: 18 months and 36 months
Change from baseline in MoCA score
Time frame: 18 months and 36 months
Change from baseline in CDR score
Time frame: 18 months and 36 months
Activities of daily living
Time frame: 18 months and 36 months
Anxiety
Time frame: 18 months and 36 months
Depression
Time frame: 18 months and 36 months
Sleep
Time frame: 18 months and 36 months
Brain activity
Time frame: 36 months
Neurodegeneration in brain structures
Time frame: 36 months
Gut microbiota
Time frame: 18 months and 36 months
Blood biomarkers
Time frame: 18 months and 36 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2022.
- 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. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Tai chi training and Group activity in people with Mild Cognitive Impairment, run by Ruijin Hospital.
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 14 inclusion and 17 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: status not confirmed, as of the sponsor's last update on 1 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shengdi Chen, PhD (86-21-6445-4473, chensd@rjh.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of MCI converted to Alzheimer's disease. (time frame: 36 months). 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 1 Aug 2022.