Cognitive Disorder Patients and Cognitive AssessmentNCT06493669
Study on the Correlation Between Treg Immune Cells on the Muscle Content and Cognitive Functions of the Elderly
An observational study of Cognitive Disorder Patients and Cognitive Assessment, run by Fifth Affiliated Hospital, Sun Yat-Sen University at 1 site in China.
Trial summary
In order to explore the impact of the level of the elderly Treg immune cells and the effects of different fat distribution and muscle content, the impact of the level of Treg immune cells on cognitive functions is explored. The correlation between visceral fat content, subcutaneous fat content and cognitive function. Read more about this study
- Who is it for?
- Ages 40 to 90 years
- Conditions the study is for
- Cognitive Disorder Patients and Cognitive Assessment
- What is being tested?
- Cognitive assessment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2023to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 40 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Cognitive decline patient
Who may be able to join
- aged 40-90 years old
Who cannot join
- previous diagnosis of dementia (including Alzheimer's disease, Lewy body dementia, Parkinson's disease, or other dementias) were excluded.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The Fifth Affiliated Hospital of Sun Yat-sen University
Zhuhai, Guangdong, 519000
Li shan Li, master, 15818102211 ext. 86, 850144863@qq.com
About this study
In order to explore the impact of the level of the elderly Treg immune cells and the effects of different fat distribution and muscle content, the impact of the level of Treg immune cells on cognitive functions is explored. The correlation between visceral fat content, subcutaneous fat content and cognitive function.
- Being tested
- Cognitive assessment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive assessmentDiagnostic test
MoCA
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive function decline
MoCA score <26
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2024
- Study start1 May 2023
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive Disorder Patients and Cognitive AssessmentStudies 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
- Case crossover
- Time perspective
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fifth Affiliated Hospital, Sun Yat-Sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06493669
- Sponsor's protocol ID
- ZDWY.LNBK.007
- Status last verified
- Jul 2024
- First submitted
- 1 Jul 2024
- Last updated
- 10 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Correlation Between Treg Immune Cells on the Muscle Content and Cognitive Functions of the Elderly
- ClinicalTrials.gov ID
- NCT06493669
- Acronym / sponsor ID
- ZDWY.LNBK.007
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Fifth Affiliated Hospital, Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 10 Jul 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.
In order to explore the impact of the level of the elderly Treg immune cells and the effects of different fat distribution and muscle content, the impact of the level of Treg immune cells on cognitive functions is explored. The correlation between visceral fat content, subcutaneous fat content and cognitive function.
Study design
- Observational model
- Case crossover
- Time perspective
- Retrospective
Who may qualify
- Ages
- 40 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Cognitive decline patient
Key inclusion criteria (1 listed)
- aged 40-90 years old
Key exclusion criteria (1 listed)
- previous diagnosis of dementia (including Alzheimer's disease, Lewy body dementia, Parkinson's disease, or other dementias) were excluded.
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 |
|---|---|---|
| Cognitive assessmentMoCA | Diagnostic test | – |
Primary outcome
Cognitive function decline
Time frame: through study completion, an average of 1 year
MoCA score <26
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2024.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
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 Disorder Patients and Cognitive Assessment, run by Fifth Affiliated Hospital, Sun Yat-Sen University 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 10 Jul 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Li Li (15818102211, 850144863@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cognitive function decline (time frame: through study completion, an average of 1 year). 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 10 Jul 2024.