Long Term Prospective Study of Tai Chi Intervention to Delay the Progression of Subjective Cognitive Impairment (TIPS)

This is an interventional prevention trial for Subjective Cognitive Impairment focused on measuring subjective cognitive impairment, Tai Chi Read More

Inclusion Criteria:

1. Male and female participants aged 60 to 75 years (inclusive) at the time of screening;
2. Willing and able to give informed consent by GCP and local guidance;

3. Meets the diagnostic criteria for subjective cognitive impairment (SCI) and the following criteria

   • Subjective decline in memory, rather than other domains of cognition
   • Onset of SCI within the last 5 y
   • Concerns (worries) associated with SCI
   • Feeling of worse performance than others of the same age group
   • Confirmation of cognitive decline by an informant.
4. Have the physical, cognitive, listening, speech, literacy and language skills necessary to participate in all tests;
5. Capable of performing MR.

Exclusion Criteria:

1. 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;
2. Abnormal folate, thyroid, and/or vitamin B12 values that cannot be corrected before baseline visit;
3. 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;
4. Geriatric Depression Scale-15(GDS-15) total score > 7 at screening;
5. MOCA<26 points;
6. CDR global score >0;
7. Hachinski ischemia score >4;

8. During the clinical study, the following drugs are prohibited:

   Acetylcholinesterase inhibitors, N-methyl-D-aspartate (NMDA) antagonists (eg, memantine), central nervous system stimulants, and various medicines that can improve memory or cognition; Antipsychotics

9. 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.
10. DSM V diagnosis of alcohol or other substance abuse dependence within the last 12 months.
11. 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.
12. 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.

13. Cancer except:

    History of any cancer that has been in remission (no evidence of recurrence) for > 5 years from the screening Participants with basal cell or stage I squamous cell carcinoma of the skin, stable untreated cancer as prostate or meningioma.

14. Active physical activity for 6 months prior to screening.

15. Participants are excluded if they

    1. have participated in any other clinical study within 4 weeks prior to screening visit
    2. have participated in another Tai chi clinical study at any time
    3. plan to take part in another clinical study during this study.
16. The researcher estimates that the subject's compliance is poor, and it is believed that the subject is unlikely to complete the study.