Chinese Classics Recitation Training in Subjective Cognitive Decline

NCT07463391 | Not Yet Recruiting

• 1 other identifier: CMUH115-REC2-001
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Subjective Cognitive Decline (SCD); Subjective Cognitive Decline

Keywords

subjective cognitive decline; memory training; Chinese Classics; recitation; randomized controlled trial

Outcome Measures

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.

  Baseline and 6 months

Secondary Outcomes (17)

• 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

Study Arms (2)

Intervention

EXPERIMENTAL

Chinese Classics Recitation for six months

Behavioral: Memory training by Chinese Classics recitation

non-active control

NO INTERVENTION

Interventions

Memory training by Chinese Classics recitation BEHAVIORAL

At least five minutes memory training per day, for six months

Intervention

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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?

You may not qualify if:

• 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)

Sponsors & Collaborators

• China Medical University Hospital: lead

Study Sites (1)

China Medical University Hospital

Taichung, 404, Taiwan

Location

Central Study Contacts

Sheng-Ta Tsai, M.D., Ph.D.

CONTACT

886-928262460; tshengdar@gmail.com

Study Design

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

Study Record Dates

• First Submitted: March 1, 2026
• First Posted: March 11, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): July 31, 2029
• Study Completion (Estimated): December 31, 2032
• Last Updated: March 11, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share

Locations

TW (1)