Cognitive DysfunctionNCT06215274
Cognitive Leisure and Preclinical Alzheimer's Disease: Exploring Neural Mechanisms
An observational study of Cognitive Dysfunction, run by Yuanjiao Yan at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cognitive Dysfunction
- What is being tested?
- Relationship of the cognitive leisure activity levels, cognitive function, and MRI characteristics.
- How many people
- 156 participants
- Where
- 1 siteChina
- Study dates
- 27 Apr 2024to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Older adults in the stage of preclinical AD
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Fujian Provincial Hospital
Fuzhou, Fujian, 350001
yuanjiao yan, PhD, +8618120826271, yuanjiao1994@126.com
About this study
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
The goal of this clinical trial is aims to:
- Translate and culturally adapt the Cognitive Leisure Activity Scale (CLAS) into Chinese and Conduct reliability and validity tests for the Chinese version of CLAS.
- Investigate the correlation between cognitive leisure activity levels and cognitive function in the preclinical stage of Alzheimer's Disease (AD).
- Clarify the regulatory mechanisms of cognitive leisure activity levels on the neural circuits of patients in the preclinical stage of AD.
Read the 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.
- Conditions
- Cognitive Dysfunction
- Being tested
- Relationship of the cognitive leisure activity levels, cognitive function, and MRI characteristics.
- Keywords
- Alzheimer's Disease, Cognitive Leisure activity, MRI
- Medical subject headings
- Cognitive Dysfunction, Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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).
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Relationship of the cognitive leisure activity levels, cognitive function, and MRI characteristics. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline
Secondary outcomes (9)
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.
Measured: Baseline
Verbal fluency
The Chinese version of Verbal Fluency Test will be used. A higher score indicates better verbal language performance.
Measured: Baseline
Executive function
The Chinese version of Shape Trail Test will be used. The shorter the usage time indicates better executive functioning.
Measured: Baseline
Visuospatial skills
The Chinese version of Rey-Osterrieth Complex Figure Test will be used. A higher score indicates better visual-spatial structural abilities.
Measured: Baseline
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.
Measured: Baseline
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.
Measured: Baseline
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.
Measured: Baseline
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.
Measured: Baseline
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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2024
- Study start27 Apr 2024
- Primary completion30 Jun 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 156 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yuanjiao Yan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yuanjiao Yan, Fujian Provincial Hospital
- Investigators
- Yuanjiao Yan, PHD, Study director, Fujian Provincial Hospital\Shengli clinical medical college of Fujian Medical university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06215274
- Sponsor's protocol ID
- K2023-12-004
- Status last verified
- May 2024
- First submitted
- 29 Dec 2023
- Last updated
- 17 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06215274
- Acronym / sponsor ID
- K2023-12-004
- Conditions
- Cognitive Dysfunction
- Keywords
- Alzheimer's Disease, Cognitive Leisure activity, MRI
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 156 participants (estimated)
- Lead sponsor
- Yuanjiao YanUniversity, hospital or other
- Study start
- 27 Apr 2024 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 22 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is aims to:
- Translate and culturally adapt the Cognitive Leisure Activity Scale (CLAS) into Chinese and Conduct reliability and validity tests for the Chinese version of CLAS.
- Investigate the correlation between cognitive leisure activity levels and cognitive function in the preclinical stage of Alzheimer's Disease (AD).
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| People in the stage of preclinical Alzheimer's disease | – | Other: Relationship of the cognitive leisure activity levels, cognitive function, and MRI characteristics.Observe the cognitive leisure activity levels, cognitive function, and MRI characteristics in patients in the preclinical stage of Alzheimer's Disease |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Older adults in the stage of preclinical AD
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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). | Other | People in the stage of preclinical Alzheimer's disease |
Primary outcome
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.
9 secondary outcomes
Memory
Time frame: Baseline
Verbal fluency
Time frame: Baseline
Executive function
Time frame: Baseline
Visuospatial skills
Time frame: Baseline
Naming difficulty
Time frame: Baseline
Amplitude of Low-Frequency Fluctuations
Time frame: Baseline
Regional Homogeneity
Time frame: Baseline
Functional Connectivity
Time frame: Baseline
General cognitive function
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2024.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yuanjiao Yan, PHD study director
Fujian Provincial Hospital\Shengli clinical medical college of Fujian Medical university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cognitive Dysfunction, run by Yuanjiao Yan at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fayang Lian, MD (0591-87557768 ext. 86, fjslkyk@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cognitive leisure activity levels (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2024.