The Effect of Memory Training by Chinese Classics Recitation on Individuals With Subjective Cognitive Decline
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change in task-related brain activation measured by functional MRI
研究概览
简要总结
Subjective cognitive decline (SCD) is considered a preclinical condition associated with an increased risk of dementia and Alzheimer's disease. Effective early behavioral interventions remain limited, and the neurobiological mechanisms underlying cognitive training effects are not fully understood, particularly in culturally specific educational contexts.
This randomized, assessor-blinded, controlled clinical trial will enroll 60 individuals with SCD to evaluate the effects of a six-month structured Chinese Classics recitation training program. Participants will be randomly assigned to either an intervention group or a non-active control group. Assessments will be conducted at baseline, immediately post-intervention, and during annual follow-up.
Multimodal evaluations will include neuropsychological testing, functional magnetic resonance imaging (fMRI), electroencephalography (EEG), blood biomarker profiling, gut microbiota analysis, and fecal metabolomics. The study aims to examine clinical outcomes and explore potential neurobiological and systemic correlates associated with culturally adapted cognitive training.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 60 years old
- •At least two "yes" responses to the following questions are required:
- •Forgetting where things are placed?
- •Unable to recall the names of good friends?
- •Unable to follow and recall conversation?
- •Subjective memory problems?
- •Consider own memory to be worse than others of a similar age?
排除标准
- •Objective cognitive impairment defined as ≥ 1.5 standard deviations below standardized cognitive testing (e.g., MMSE)
- •Diagnosis of MCI
- •Clinical Dementia Rating (CDR) ≥ 0.5
- •Diagnosis of major depressive disorder
- •Beck Anxiety Inventory score ≥ 16
- •Other medical or neurological conditions that could explain cognitive decline (e.g., vascular dementia, traumatic brain injury)
- •Claustrophobia
- •Contraindications of MRI (e.g., non-MRI-compatible cardiac pacemaker or devices implanted within the past three months)
研究组 & 干预措施
Intervention
Chinese Classics Recitation for six months
干预措施: Memory training by Chinese Classics recitation (Behavioral)
non-active control
结局指标
主要结局
Change in task-related brain activation measured by functional MRI
时间窗: Baseline and 6 months
Unit of measure: Whole-brain blood-oxygen-level-dependent (BOLD) signal change (%) Detail Functional magnetic resonance imaging (fMRI) will be used to evaluate changes in task-related brain activation associated with the intervention. Whole-brain blood-oxygen-level-dependent (BOLD) signals will be analyzed using voxel-wise general linear modeling to identify activation patterns during task performance compared with resting baseline. First-level analyses will generate subject-specific contrast maps reflecting task-related neural activation. Group-level random-effects analyses will then be conducted to compare activation patterns between study groups and across time points. Statistical significance will be determined using a voxel-level threshold corrected for multiple comparisons using the false discovery rate (FDR). Effect sizes extracted from significant brain regions will be used for group-level comparisons.
次要结局
- Resting-state electroencephalogram (EEG) spectral activity(Baseline and 6 months)
- Global Cognitive Function - MMSE(Baseline and 6 months)
- Global Cognitive Function - MoCA(Baseline and 6 months)
- Verbal Episodic Memory - RAVLT(Baseline and 6 months)
- Executive Function - Stroop Test(Baseline and 6 months)
- Working Memory - Digit Span(Baseline and 6 months)
- Language Function - Boston Naming Test(Baseline and 6 months)
- Dementia Severity - CDR(Baseline and 6 months)
- Vascular Cognitive Risk - Hachinski Score(Baseline)
- Depressive Symptoms - GDS(Baseline and 6 months)
- Anxiety Symptoms - BAI(Baseline and 6 months)
- Cognitive Reserve - CRI-q(Baseline)
- APOE genotype distribution(Baseline)
- Circulating inflammatory and stress biomarkers (IL-6, TNF-α, hsCRP, and cortisol)(Baseline and 6 months)
- Gut microbiota diversity (Shannon index)(Baseline and 6 months)
- Gut microbiota taxonomic composition(Baseline and 6 months)
- Fecal metabolomic profiles related to the gut-brain axis(Baseline and 6 months)
研究者
Sheng-Ta Tsai
Principal Investigator
China Medical University Hospital