Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06215274

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

Recruiting

Interested in participating?

Request Info

Key information

Age range

60 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Fujian Provincial Hospital

Fuzhou, Fujian, 350001, China

Location status: Recruiting

Location contact

yuanjiao yan, PhD

CONTACT

[email protected]

+8618120826271

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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).

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. Verbal fluency

    Time frame: Baseline

    The Chinese version of Verbal Fluency Test will be used. A higher score indicates better verbal language performance.

  3. Executive function

    Time frame: Baseline

    The Chinese version of Shape Trail Test will be used. The shorter the usage time indicates better executive functioning.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Fayang Lian, MD

CONTACT

[email protected]

0591-87557768 ext. 86

Sponsors and collaborators

Lead sponsor

Yuanjiao Yan

Other

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jan 22, 2024
Registry last updated
May 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.