Chinese Classics Recitation Training in Subjective Cognitive Decline
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60+
SponsorChina Medical University Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 60 years old
Forgetting where things are placed?
Unable to recall the names of good friends?
Unable to follow and recall conversation?
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Memory training by Chinese Classics recitation
BehavioralAt least five minutes memory training per day, for six months
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: InterventionExperimental treatment 1 intervention
Group B: non-active controlNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Change in task-related brain activation measured by functional MRI
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.
Time frame
Baseline and 6 monthsSecondary outcomes
1
Resting-state electroencephalogram (EEG) spectral activity
Unit of Measure µV²/Hz (power spectral density) Detail Resting electroencephalogram (EEG) recordings will be acquired using a standard 21-electrode montage positioned according to the International 10-20 system. Electrode impedance will be maintained below 10 kΩ, with a minimum sampling rate of 256 Hz. Recordings will be performed in a quiet, dimly lit environment with participants seated comfortably and instructed to remain awake with their eyes closed. EEG preprocessing and analysis will be conducted using MNE-Python implemented in Python. The preprocessing pipeline will include re-referencing, resampling to 250 Hz, and band-pass filtering between 0.1 and 41 Hz. Artifact-free EEG signals will be segmented into non-overlapping 2-second epochs for subsequent spectral analysis. Quantitative EEG measures will be derived from the processed signals to characterize resting-state brain activity.
Time frame
Baseline and 6 months2
Global Cognitive Function - MMSE
Outcome Measure Total score on the Mini-Mental State Examination (MMSE) Unit of Measure points Detail The MMSE is a widely used cognitive screening instrument assessing orientation, attention, memory, language, and visuospatial ability. Total score ranges from 0-30, with higher scores indicating better cognitive function.
Time frame
Baseline and 6 months3
Global Cognitive Function - MoCA
Outcome Measure Total score on the Montreal Cognitive Assessment (MoCA) Unit of Measure points Detail The MoCA evaluates multiple cognitive domains including executive function, memory, attention, language, abstraction, and orientation. Total score ranges from 0-30, with higher scores indicating better cognitive performance.
Time frame
Baseline and 6 months4
Verbal Episodic Memory - RAVLT
Outcome Measure Total recall score on the Rey Auditory Verbal Learning Test (RAVLT) Unit of Measure points Detail The RAVLT assesses verbal learning and episodic memory through repeated recall of word lists across trials. Total recall score reflects the number of correctly recalled words, with higher scores indicating better memory performance.
Time frame
Baseline and 6 monthsSponsors and contacts
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Source ClinicalTrials.gov
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