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

Cognitive Dysfunction Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06215274
• Other study ID #: K2023-12-004
• Status: Recruiting
• Start date: April 27, 2024
• Est. completion date: December 31, 2026

Study information

• Verified date: May 2024
• Source: Fujian Provincial Hospital
• Contact: Fayang Lian, MD
• Phone: 0591-87557768
• Email: fjslkyk[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 156
• Est. completion date: December 31, 2026
• Est. primary completion date: June 30, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Alzheimer Disease
• Cognitive Dysfunction

Intervention

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).

Locations

Country	Name	City	State
China	Fujian Provincial Hospital	Fuzhou	Fujian

Sponsors (1)

Lead Sponsor	Collaborator
Yuanjiao Yan

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cognitive leisure activity levels	The Chinese version of Cognitive & leisure activity scale will be used. Utilizing the Likert 5-point scale with 16 items, total score ranges from 0 to 80 points,higher scores signify increased cognitive leisure activity levels. An abnormal level is determined if the score is below 25 points.	Baseline
Secondary	Memory	The Chinese version of Auditory Verbal Learning Test will be used. This includes immediate memory, short-term memory, long-term memory, and recognition memory. A higher score indicates better memory performance.	Baseline
Secondary	Verbal fluency	The Chinese version of Verbal Fluency Test will be used. A higher score indicates better verbal language performance.	Baseline
Secondary	Executive function	The Chinese version of Shape Trail Test will be used. The shorter the usage time indicates better executive functioning.	Baseline
Secondary	Visuospatial skills	The Chinese version of Rey-Osterrieth Complex Figure Test will be used. A higher score indicates better visual-spatial structural abilities.	Baseline
Secondary	Naming difficulty	The Chinese version of Boston Naming Test will be used. The total scores range from 0 to 30, a higher score indicates better language functioning.	Baseline
Secondary	Amplitude of Low-Frequency Fluctuations	The rest-state functional MRI of Amplitude of Low-Frequency Fluctuations analysis will be performed to investigate the variations in MRI features across different cognitive leisure activities and levels of cognitive functioning.	Baseline
Secondary	Regional Homogeneity	The rest-state functional MRI of Regional Homogeneity analysis will be performed to investigate the variations in MRI features across different cognitive leisure activities and levels of cognitive functioning.	Baseline
Secondary	Functional Connectivity	The rest-state functional MRI of Functional Connectivity analysis will be performed to investigate the variations in MRI features across different cognitive leisure activities and levels of cognitive functioning.	Baseline
Secondary	General cognitive function	The Chinese version of Montreal Cognitive Assessment will be used.The scale has a total score of 30 points, encompassing eight assessment sections: visual-spatial and executive function, naming, memory, attention, language, abstraction, delayed recall, and orientation. It involves multiple cognitive domains. A higher score indicates better cognitive functioning.	Baseline