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Recruiting NCT06215274

Cognitive Leisure and Preclinical Alzheimer's Disease: Exploring Neural Mechanisms

Observational Cognitive Dysfunction

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Relationship of the cognitive leisure activity levels, cognitive function, and MRI characteristics..
Who it may be relevant to
Registry conditions: Cognitive Dysfunction. Basic parameters: from 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

The Impact of Cognitive Leisure Activity Levels on Cognitive Function in the Preclinical Stage of Alzheimer's Disease and the Study of Its Neural Circuitry Regulation Mechanisms

Overview

The goal of this clinical trial is aims to: 1. Translate and culturally adapt the Cognitive Leisure Activity Scale (CLAS) into Chinese and Conduct reliability and validity tests for the Chinese version of CLAS. 2. Investigate the correlation between cognitive leisure activity levels and cognitive function in the preclinical stage of Alzheimer's Disease (AD). 3. Clarify the regulatory mechanisms of cognitive leisure activity levels on the neural circuits of patients in the preclinical stage of AD.

Detailed description

Alzheimer's disease (AD), also known as senile dementia, is the most common neurodegenerative disorder characterized by progressive decline in cognitive function and behavioral impairment. It is estimated that there are approximately 9.83 million AD patients in China, with an average annual treatment cost of about $19,144 per person, accounting for 1.47% of the national gross domestic product, surpassing the global average. This not only severely affects the quality of life for elderly patients but also imposes a heavy economic and caregiving burden on families and society.

Due to the limitations of AD treatment and the irreversibility of its progression, early detection and intervention have become the focus of AD prevention and control efforts. Increasingly, scholars propose shifting the diagnosis and intervention of AD to the preclinical stage, particularly the mild cognitive impairment (MCI) phase and even earlier stages characterized by subjective cognitive decline (SCD). Cognitive leisure activity, as one of the potentially modifiable factors in the preclinical stage of AD, understanding its impact on cognitive function and the neural circuitry regulation mechanisms in this stage is of significant importance. This knowledge can contribute to the development of early targeted intervention measures, preventing or delaying the onset and progression of AD, and promoting healthy aging.

Interventions

  • Other Relationship of the cognitive leisure activity levels, cognitive function, and MRI characteristics.
    The cognitive leisure activity levels, cognitive function, and MRI characteristics in people in the preclinical stage of Alzheimer's Disease (AD).

Primary outcome measures

  • Cognitive leisure activity levels [Time frame: Baseline]
Secondary outcome measures (9)
  • Memory [Time frame: Baseline]
  • Verbal fluency [Time frame: Baseline]
  • Executive function [Time frame: Baseline]
  • Visuospatial skills [Time frame: Baseline]
  • Naming difficulty [Time frame: Baseline]
  • Amplitude of Low-Frequency Fluctuations [Time frame: Baseline]
  • Regional Homogeneity [Time frame: Baseline]
  • Functional Connectivity [Time frame: Baseline]
  • General cognitive function [Time frame: Baseline]

Eligibility criteria

Inclusion criteria

  • Clinical diagnosis of Mild Cognitive Impairment (MCI) and Subjective Cognitive Decline (SCD)
  • Age ≥ 60 years
  • Capable of normal communication in Mandarin,possesses a certain level of comprehension and judgment.

Exclusion criteria

  • Individuals with severe hearing or language impairments, or with severe physical illnesses that are unable to cooperate with the survey
  • Individuals with pacemakers, metallic implants, cochlear implants, claustrophobia, and other contraindications for MRI examination.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

China · 1 center
  • Fujian Provincial Hospital — Fuzhou

Identifiers

NCT: NCT06215274 · K2023-12-004

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗