Long Term Prospective Study of Tai Chi Intervention to Prevent MCI From Conversion to Dementia

NCT05310890 | Not Yet Recruiting DMC

• 1 other identifier: TIME study
• Study Type: interventional
• Target: 206
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Mild Cognitive Impairment

Keywords

Mild Cognitive Impairment; Tai Chi

Outcome Measures

Primary Outcomes (2)

• Incidence of MCI converted to Alzheimer's disease.

  The 3-year incidence of AD in each group will be compared.

  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.

  18 months and 36 months

Secondary Outcomes (17)

• Memory

  18 months and 36 months

• Attention

  18 months and 36 months

• Executive function

  18 months and 36 months

• Language

  18 months and 36 months

• Working memory test

  18 months and 36 months

Study Arms (2)

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.

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.

Behavioral: Group activity

Interventions

Tai chi training BEHAVIORAL

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.

Tai chi training plus group activity

Group activity BEHAVIORAL

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.

Only group activity; Tai chi training plus group activity

Eligibility Criteria

• Age: 55 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Ruijin Hospital: lead
• Zhangjiagang Aoyang Hospital of Jiangsu Province: collaborator

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Central Study Contacts

Shengdi Chen, PhD

CONTACT

86-21-6445-4473; chensd@rjh.com.cn

Chao Gao, PhD

CONTACT

86-18217590273; anshangaochao@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 17, 2022
• First Posted: April 5, 2022
• Study Start: September 1, 2022
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: August 1, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share