Brain Aging Related ConditionsNCT06066775
Endocrine Glucose & Lipids Metabolism and Brain Aging: a Longitudinal Study
An observational study of Brain Aging Related Conditions, run by Shandong Provincial Hospital at 1 site in China.
Trial summary
With aging, brain aging leads to a general decline in cognitive ability, and the prevalence of neurodegenerative diseases such as Alzheimer's disease (AD) and Parkinson's disease (PD) increases. The prevalence of abnormal glucose and lipid metabolism also increased with age. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Brain Aging Related Conditions
- What is being tested?
- Observation study without intervention
- How many people
- 10,000 participants
- Where
- 1 siteChina
- Study dates
- 4 Jul 2023to Dec 2033
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: In phase 1, 10000 individuals selected from 10-12 communities stratified according to geographic regions. Among them, 1000-2000 individuals receive the MRI examination. In Phase 2, 10000 individuals recruited in phase 2 follow-up. Among them, 1000-2000 individuals with the baseline MRI examination will again receive the MRI examination during the follow-up
Who may be able to join
- Age >= 50 years old;
- Gender: males and females;
- Provide written informed consent;
- Satisfactory compliance.
Who cannot join
- Pregnant or lactating women
- No history of addiction or neurological, psychiatric, or systemic diseases known to affect cognitive function, including head trauma, subdural hematoma, current depression, and epilepsy
- Any other condition or major systemic diseases that the investigator feels would interfere with trial participation or evaluation of results.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Jiajun Zhao contact
China1 site, 1 recruiting
- Recruiting
Shandong Provincial Hospital Affiliated to Shandong First Medical University
Jinan, Shandong, 250021
Lijie Wang, +8618253166055, lijiewang19@163.com
About this study
Official title: A Prospective Cohort Study on the Associations of Endocrine Glucose & Lipids With Brain Aging-related Conditions in Chinese Men and Women
With aging, brain aging leads to a general decline in cognitive ability, and the prevalence of neurodegenerative diseases such as Alzheimer's disease (AD) and Parkinson's disease (PD) increases. The prevalence of abnormal glucose and lipid metabolism also increased with age. The imbalance of glucose and lipid metabolism is closely related to brain aging related conditions and diseases, and the relationship between glucose and lipid metabolism and brain aging has not been fully elucidated.
Phase 1: Baseline investigation (community-based survey) Aims: To investigate whether glucose and lipids are the risk factors for brain aging-related conditions, such as mild cognitive impairment.
Read more
Subjects and Methods: A community-based survey will be carried out in 10000 natural population aged >=50 years selected from 10-12 communities stratified according to geographic regions (Ciyao, Huafeng, Dongzhuang, Heshan, Geshi, Jiangji, Gangcheng, Fushan, Dongshu, Sidian, Baxianqiao, and Xiangyin, etc) in Ningyang County, Taian City, Shandong Province. A comprehensive examination including questionnaire (including the MMSE and ADL evaluation for the participants), anthropometric measurements, biochemical analysis will be performed in each study participant. In particular, the investigators randomly selected 1000-2000 participants performing MRI of the brain to evaluate the brain aging related conditions.
Phase 2: Cohort follow-up Aims : To examine glucose and lipids metabolism levels and their changes that modify the risk of brain aging-related conditions.
Subjects and Methods: To recruit and follow all 10000 participants for at least 3-5 years. In particular, all 1000-2000 participants with the baseline MRI examination will perform the MRI examination again for the follow-up.
- Conditions
- Brain Aging Related Conditions
- Being tested
- Observation study without intervention
- Keywords
- brain aging, cognition, lipid, glucose
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observation study without interventionOther
Observation study without intervention
What is being measured
The primary outcome is the main question the study is designed to answer.
number of participants who develop brain aging-related conditions during follow-up
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2023
- Study start4 Jul 2023
- Primary completionDec 2024 (estimated)
- Study completionDec 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain Aging Related ConditionsStudies 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
- 10,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shandong Provincial Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Jia-jun Zhao, Shandong Provincial Hospital
- Investigators
- Jiajun Zhao, Study chair, Shandong Provincial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06066775
- Sponsor's protocol ID
- 20230907
- Status last verified
- Oct 2023
- First submitted
- 27 Sep 2023
- Last updated
- 6 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Cohort Study on the Associations of Endocrine Glucose & Lipids With Brain Aging-related Conditions in Chinese Men and Women
- ClinicalTrials.gov ID
- NCT06066775
- Acronym / sponsor ID
- 20230907
- Conditions
- Brain Aging Related Conditions
- Keywords
- brain aging, cognition, lipid, glucose
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- Shandong Provincial HospitalOther government
- Study start
- 4 Jul 2023 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2033 (estimated)
- First posted
- 4 Oct 2023 (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.
With aging, brain aging leads to a general decline in cognitive ability, and the prevalence of neurodegenerative diseases such as Alzheimer's disease (AD) and Parkinson's disease (PD) increases. The prevalence of abnormal glucose and lipid metabolism also increased with age. The imbalance of glucose and lipid metabolism is closely related to brain aging related conditions and diseases, and the relationship between glucose and lipid metabolism and brain aging has not been fully elucidated.
Phase 1: Baseline investigation (community-based survey) Aims: To investigate whether glucose and lipids are the risk factors for brain aging-related conditions, such as mild cognitive impairment.
Subjects and Methods: A community-based survey will be carried out in 10000 natural population aged >=50 years selected from 10-12 communities stratified according to geographic regions (Ciyao, Huafeng, Dongzhuang, Heshan, Geshi, Jiangji, Gangcheng, Fushan, Dongshu, Sidian, Baxianqiao, and Xiangyin, etc) in Ningyang County, Taian City, Shandong Province. A comprehensive examination including questionnaire (including the MMSE and ADL evaluation for the participants), anthropometric measurements, biochemical analysis will be performed in each study participant. In particular, the investigators randomly selected 1000-2000 participants performing MRI of the brain to evaluate the brain aging related conditions.
Phase 2: Cohort follow-up Aims : To examine glucose and lipids metabolism levels and their changes that modify the risk of brain aging-related conditions.
Subjects and Methods: To recruit and follow all 10000 participants for at least 3-5 years. In particular, all 1000-2000 participants with the baseline MRI examination will perform the MRI examination again for the follow-up.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- In phase 1, 10000 individuals selected from 10-12 communities stratified according to geographic regions. Among them, 1000-2000 individuals receive the MRI examination. In Phase 2, 10000 individuals recruited in phase 2 follow-up. Among them, 1000-2000 individuals with the baseline MRI examination will again receive the MRI examination during the follow-up
Key inclusion criteria (4 listed)
- Age >= 50 years old;
- Gender: males and females;
- Provide written informed consent;
- Satisfactory compliance.
Key exclusion criteria (3 listed)
- Pregnant or lactating women
- No history of addiction or neurological, psychiatric, or systemic diseases known to affect cognitive function, including head trauma, subdural hematoma, current depression, and epilepsy
- Any other condition or major systemic diseases that the investigator feels would interfere with trial participation or evaluation of results.
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 |
|---|---|---|
| Observation study without interventionObservation study without intervention | Other | – |
Primary outcome
number of participants who develop brain aging-related conditions during follow-up
Time frame: 5 years
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 6 Oct 2023.
- Individual participant dataSharing planned: Undecided
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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.
Jiajun Zhao contact
Jiajun Zhao study chair
Shandong Provincial Hospital
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 Brain Aging Related Conditions, run by Shandong Provincial Hospital 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 4 inclusion and 3 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 6 Oct 2023. 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 Ling Gao (+8613793187189, gaoling1@medmail.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of participants who develop brain aging-related conditions during follow-up (time frame: 5 years). 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 6 Oct 2023.