Neuroimaging research of brain aging in the elderly in the community
| ISRCTN | ISRCTN13222678 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13222678 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | Nil known |
| Sponsor | Shandong Provincial Hospital Affiliated to Shandong First Medical University |
| Funder | Shandong Provincial Hospital Affiliated to Shandong First Medical University |
- Submission date
- 20/02/2024
- Registration date
- 28/02/2024
- Last edited
- 28/02/2024
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Nervous System Diseases
Plain English summary of protocol
Background and study aims
This project seeks to investigate how the aging process affects the brain and its impact on cognitive abilities and physical movement in adults who are middle-aged and elderly. Additionally, it aims to understand the mechanisms that connect changes in the aging brain to alterations in mental health and cognitive function. By doing so, it aims to enhance our ability to diagnose and predict conditions related to brain aging and to pinpoint potential treatments.
Who can participate?
All subjects aged 40 - 70 years
What does the study involve?
The research includes evaluating how people think and move, testing blood for various substances, and taking images of the brain using a technique called quantitative susceptibility mapping (QSM).
What are the possible benefits and risks of participating?
None
Where is the study run from?
Shandong Provincial Hospital Affiliated to Shandong First Medical University (China)
When is the study starting and how long is it expected to run for?
November 2018 to December 2028
Who is funding the study?
Shandong Provincial Hospital Affiliated to Shandong First Medical University (China)
Who is the main contact?
Lingfei Guo, glfsci@163.com
Contact information
Public, Scientific, Principal investigator
Shandong Provincial Hospital Affiliated to Shandong First Medical University
Jinan
250021
China
 ORCID ID |
0000-0002-4885-625X |
|---|---|
| Phone | +86 531-68776789 |
| guolingfei@sdfmu.edu.cn |
Study information
| Primary study design | Observational |
|---|---|
| Study design | Observational cross sectional |
| Secondary study design | Cross sectional study |
| Scientific title | Neuroimaging study on the correlation between brain aging and cognitive-motor function in the middle-aged and elderly population |
| Study objectives | This project aims to explore the correlation between brain aging and cognitive-motor function in the middle-aged and elderly population and to elucidate pathways from age-related brain changes to neuropsychiatric changes, improving diagnosis and prognosis and identifying therapeutic targets. |
| Ethics approval(s) |
Approved 18/11/2019, Shandong Institute of Medical Imaging (324 Jing-wu Road, Jinan, Shandong, Jinan, 250021, China; +86 68776789; kewaichu@126.com), ref: 2019-002 |
| Health condition(s) or problem(s) studied | Brain aging |
| Intervention | We intend to utilize the most current Quantitative susceptibility mapping (QSM) data available to examine and evaluate the correlation between iron accumulation and neuropsychiatric disorders. Extensive health data will be utilized to evaluate and compare vascular, inflammatory, metabolic, and genetic risk factors for brain ageing in the elderly and progression through techniques such as regression analyses, and mediation modelling. |
| Intervention type | Other |
| Primary outcome measure(s) |
Brain iron is measured using Quantitative susceptibility mapping (QSM) at baseline, 2 years and 5 years. |
| Key secondary outcome measure(s) |
Brain iron measured using QSM at 2 years. |
| Completion date | 01/12/2028 |
Eligibility
| Participant type(s) | Healthy volunteer, Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 40 Years |
| Upper age limit | 80 Years |
| Sex | All |
| Target sample size at registration | 3000 |
| Key inclusion criteria | 1. Age from 40 to 80 years old 2. Right-handedness |
| Key exclusion criteria | 1. History of brain trauma, surgery, or tumors 2. Acute complications of type 2 diabetes 3. Severe hypertension 4. History of severe cerebrovascular, neurological, or mental diseases 5. Alcohol or drug abuse 6. MRI contraindications |
| Date of first enrolment | 01/12/2018 |
| Date of final enrolment | 01/11/2028 |
Locations
Countries of recruitment
- China
Study participating centre
Jinan
250021
China
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan | The datasets generated during and/or analysedduring the current study will be available upon request from Lingfei Guo, glfsci@163.com |
Editorial Notes
20/02/2024: Trial's existence confirmed by Shandong Institute of Medical Imaging.
