Clinical trial NCT06215274: Cognitive Leisure and Preclinical Alzheimer's Disease: Exploring Neural Mechanisms
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cognitive Dysfunction
Keywords: Alzheimer's Disease
Cognitive Leisure activity
MRI
Lead sponsor: Fujian Provincial Hospital
Sponsor class: OTHER
First posted: 2024-01-22
Enrollment: 156
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Older adults in the stage of preclinical AD

Brief summary: 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.

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.

Primary outcomes:
measure: Cognitive leisure activity levels
timeFrame: Baseline
Secondary outcomes:
measure: Memory
timeFrame: Baseline
measure: Verbal fluency
timeFrame: Baseline
measure: Executive function
timeFrame: Baseline
measure: Visuospatial skills
timeFrame: Baseline
measure: Naming difficulty
timeFrame: Baseline
measure: Amplitude of Low-Frequency Fluctuations
timeFrame: Baseline
measure: Regional Homogeneity
timeFrame: Baseline
measure: Functional Connectivity
timeFrame: Baseline
measure: General cognitive function
timeFrame: Baseline
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: Fujian Provincial Hospital
state: Fujian
Study officials:
affiliation: Fujian Provincial Hospital\Shengli clinical medical college of Fujian Medical university
name: Yuanjiao Yan, PHD
role: STUDY_DIRECTOR
References: