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

May 15, 2024 updated by: Yuanjiao Yan

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

156

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Fayang Lian, MD
  • Phone Number: 86 0591-87557768
  • Email: fjslkyk@163.com

Study Locations

  • China
    • Fujian
      • Fuzhou, Fujian, China, 350001
        • Recruiting
        • Fujian Provincial Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

Older adults in the stage of preclinical AD

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
People in the stage of preclinical Alzheimer's disease
Observe the cognitive leisure activity levels, cognitive function, and MRI characteristics in patients in the preclinical stage of Alzheimer's Disease
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cognitive leisure activity levels
Time Frame: Baseline
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
General cognitive function
Time Frame: Baseline
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
Memory
Time Frame: Baseline
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
Verbal fluency
Time Frame: Baseline
The Chinese version of Verbal Fluency Test will be used. A higher score indicates better verbal language performance.
Baseline
Executive function
Time Frame: Baseline
The Chinese version of Shape Trail Test will be used. The shorter the usage time indicates better executive functioning.
Baseline
Visuospatial skills
Time Frame: Baseline
The Chinese version of Rey-Osterrieth Complex Figure Test will be used. A higher score indicates better visual-spatial structural abilities.
Baseline
Naming difficulty
Time Frame: Baseline
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
Amplitude of Low-Frequency Fluctuations
Time Frame: Baseline
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
Regional Homogeneity
Time Frame: Baseline
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
Functional Connectivity
Time Frame: Baseline
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yuanjiao Yan

Investigators

  • Study Director: Yuanjiao Yan, PHD, Fujian Provincial Hospital\Shengli clinical medical college of Fujian Medical university

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 27, 2024

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

December 29, 2023

First Submitted That Met QC Criteria

January 10, 2024

First Posted (Actual)

January 22, 2024

Study Record Updates

Last Update Posted (Actual)

May 17, 2024

Last Update Submitted That Met QC Criteria

May 15, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • K2023-12-004

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Research data and research-related materials will be available in a repository or online. After completion of the study, relevant data will be provided in the form of a URL or DOI.

IPD Sharing Time Frame

After completion of the study, relevant data will be provided in the form of a URL or DOI.

IPD Sharing Access Criteria

Researchers whose proposed use of the data has been approved

IPD Sharing Supporting Information Type

  • SAP
  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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