Long Term Prospective Study of Tai Chi Intervention to Delay the Progression of Subjective Cognitive Impairment
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Subjective Cognitive Impairment
- Sponsor
- Ruijin Hospital
- Enrollment
- 134
- Locations
- 1
- Primary Endpoint
- The global cognitive function of SCI subjects.
- Status
- Not yet recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
This study evaluates the effects of 3 years-Tai Chi exercise intervention on cognitive function in subjects with subjective cognitive impairment (SCI). Participants 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 (AD) 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. In recent years, studies have found that there is an earlier stage before MCI, that is, the stage of subjective cognitive impairment (SCI). SCI is a stage between normal aging and MCI, which is manifested by the self-reported experience of worsening or more frequent memory loss but not supported by objective evidence. Subjects with SCI are more likely to develop AD. According to the US CDC data, the prevalence of SCI among adults aged 65 years and older is 11.7%. Therefore, it is crucial to find intervention strategies to prevent the progression of SCI to MCI and dementia. However, drug interventions are currently ineffective in the prevention and treatment of such diseases. Based on the synaptic plasticity, more and more studies focus on non-drug interventions. Our research group previously found non-drug interventions (cognitive training, exercise therapy) can effectively delay cognitive decline 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 SCI subjects and to provide a new clinical basis for the prevention and treatment of cognitive disorders.
Investigators
Shengdi Chen
Professor
Ruijin Hospital
Eligibility Criteria
Inclusion Criteria
- •Male and female participants aged 60 to 75 years (inclusive) at the time of screening;
- •Willing and able to give informed consent by GCP and local guidance;
- •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.
- •Have the physical, cognitive, listening, speech, literacy and language skills necessary to participate in all tests;
- •Capable of performing MR.
Exclusion Criteria
- •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;
- •Geriatric Depression Scale-15(GDS-15) total score \> 7 at screening;
- •MOCA\<26 points;
- •CDR global score \>0;
- •Hachinski ischemia score \>4;
- •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
- •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.
Outcomes
Primary Outcomes
The global cognitive function of SCI subjects.
Time Frame: 36 months
Repeatable Battery for the Assessment of Neuropsychological Status(RBANS) will be used to assess the global cognitive performance of SCI subjects.
Secondary Outcomes
- Memory(18 months and 36 months)
- Attention(18 months and 36 months)
- Activities of daily living(18 months and 36 months)
- Visual spatial ability(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)
- Change from baseline in MoCA score(18 months and 36 months)
- Change from baseline in CDR score(18 months and 36 months)
- Anxiety(18 months and 36 months)
- Gait and Hand writing Task(18 months and 36 months)
- Depression(18 months and 36 months)
- Sleep(18 months and 36 months)
- Brain activity(36 months)
- Neurodegeneration in brain structures(36 months)
- Gut microbiota(18 months and 36 months)
- Blood biomarkers(18 months and 36 months)
- Incidence of SCI converted to MCI and Alzheimer's disease.(36 months)