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

NCT06215274 | Recruiting

• 1 other identifier: K2023-12-004
• Study Type: observational
• Target: 156
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is aims to:

1. 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. 2.Investigate the correlation between cognitive leisure activity levels and cognitive function in the preclinical stage of Alzheimer's Disease (AD).
3. 3.Clarify the regulatory mechanisms of cognitive leisure activity levels on the neural circuits of patients in the preclinical stage of AD.

Conditions

Cognitive Dysfunction

Keywords

Alzheimer's Disease; Cognitive Leisure activity; MRI

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Memory

  Baseline

• Verbal fluency

  Baseline

• Executive function

  Baseline

• Visuospatial skills

  Baseline

• Naming difficulty

  Baseline

Study Arms (1)

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.

Interventions

Relationship of the cognitive leisure activity levels, cognitive function, and MRI characteristics. OTHER

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

People in the stage of preclinical Alzheimer's disease

Eligibility Criteria

• Age: 60 Years+
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Older adults in the stage of preclinical AD

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yuanjiao Yan: lead

Study Sites (1)

Fujian Provincial Hospital

Fuzhou, Fujian, 350001, China

RECRUITING

MeSH Terms

Conditions

Cognitive Dysfunction; Alzheimer Disease

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases

Study Officials

• Yuanjiao Yan, PHD

  Fujian Provincial Hospital\Shengli clinical medical college of Fujian Medical university

  STUDY DIRECTOR

Central Study Contacts

Fayang Lian, MD

CONTACT

0591-87557768; fjslkyk@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 29, 2023
• First Posted: January 22, 2024
• Study Start: April 27, 2024
• Primary Completion: June 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 17, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP, ANALYTIC CODE
• Time Frame: After completion of the study, relevant data will be provided in the form of a URL or DOI.
• Access Criteria: Researchers whose proposed use of the data has been approved

Locations

CN (1)