Alzheimer DiseaseNCT06837272
A Longitudinal Study to Explore the Impact of Gut Microbiome on Brain Health in Alzheimer's Disease
An observational study of Alzheimer Disease and Gut Microbiota, run by Jining Medical University at 1 site in China.
Trial summary
Gut microbiota dysfunction is associated with Alzheimer's disease (AD). However, the potential modulatory mechanism remains unclear. Previous studies have shown that gut-derived metabolites short-chain fatty acids (SCFAs) may be the key mediators between gut microbiota and brain, participating in the modulatory… Read more about this study
- Who is it for?
- Ages 60 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Alzheimer Disease, Gut Microbiota, Metabonomics
- What is being tested?
- Multi-omics features extraction
- How many people
- 285 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2024to 31 Dec 2029
- How long will I take part?
- 5 Years
- 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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Volunteers recruited from both clinical and communities, and signed up with informed consent.
Who may be able to join
- Cognitively normal group:
- normal performance on standardized cognitive tests;
- with no cognitive complaints or any concerns (worries).
- SCD group:
- self-experienced persistent decline in memory, rather than other domains of cognition;
- normal performance on standardized cognitive tests;
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- failure to meet the criteria for MCI or dementia;
- age at onset of SCD ≥ 60 years old;
- onset of SCD within the last 5 years;
- concerns (worries) associated with SCD;
- feeling of worse performance than others of the same age group.
- MCI group:
- having impaired scores on both measures in at least one cognitive domain (memory, language, or speed/executive function);
- having impaired scores in each of the three cognitive domains (memory, language, or speed/executive function);
- the Functional Activities Questionnaire (FAQ)≥9.
- AD dementia group:
- meet the criteria for dementia and have impaired daily functional activities;
- episodic memory deficit; 3) Clinical Dementia Rating (CDR) ≥ 1.
Who cannot join
- a history of stroke;
- major depression and anxiety;
- other central nervous system disorders that may cause cognitive impairment, such as Parkinson's disease, tumors, encephalitis, and epilepsy;
- cognitive impairment caused by traumatic brain injury;
- systemic diseases, such as thyroid dysfunction, syphilis and HIV;
- psychosis or congenital mental developmental delay;
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- a history of using antibiotics, probiotics, prebiotics, or synbiotics within 3 months;
- the use of corticosteroid, immune stimulating medications, and immunosuppressive agents;
- major gastrointestinal tract surgery in past 5 years;
- severe gastrointestinal diseases, such as irritable bowel syndrome, infammatory bowel disease, severe gastritis, other dysfunction in digestion and absorption, which has been reported to infuence gut microbiota
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
Department of Neurolgy, the Affiliated Hospital of Jining Medical University
Jining, Shandong, 272029
Can Sheng, PhD, 86-18701257298, canyeweiwu2013@163.com
Yun Guo, Master, 86-18863030588, yun125985@163.com
About this study
Official title: A Longitudinal Study to Explore the Impact of Gut Microbiome on Brain Health in Alzheimer's Disease: China Healthy Brain and Gut Microbiome Study (CHBGMS)
Gut microbiota dysfunction is associated with Alzheimer's disease (AD). However, the potential modulatory mechanism remains unclear. Previous studies have shown that gut-derived metabolites short-chain fatty acids (SCFAs) may be the key mediators between gut microbiota and brain, participating in the modulatory pathway "gut microbiota-SCFAs-brain networks". In this project, high-throughput targeted metabolomics technique will be used to explore the differences of SCFAs in the spectrum of AD, including cognitively normal individuals, subjective cognitive decline (SCD), mild cognitive impairment (MCI), and AD dementia. Then, the gut microbiome and multi-modal MRI techniques will be combined to elucidate potential interaction mechanisms of "gut microbiota-SCFAs-brain networks". Finally, based on multi-omics features extracted from gut microbiome, metabolomics, and neuroimaging after five years, the diagnostic model of SCD due to preclinical AD will be established using machine learning methods.
- Being tested
- Multi-omics features extraction
- Keywords
- Subjective cognitive decline, Multi-omics
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multi-omics features extractionDiagnostic test
Based on multi-omics features extracted from clinical data, gut microbiome, metabolomics, and multi-modal MRI, the diagnostic model of SCD due to preclinical AD will be established.
| Study group | Role | What they receive |
|---|---|---|
| Cognitively normal group | (1) normal performance on standardized cognitive tests; (2) with no cognitive complaints or any concerns (worries). | |
| Subjective cognitive decline (SCD) group | (1) self-experienced persistent decline in memory, rather than other domains of cognition; (2) normal performance on standardized cognitive tests; (3) failure to meet the criteria for MCI or dementia; (4) age at onset of SCD ≥ 60 years old; (5) onset of SCD within the last 5 years; (6) concerns (worries) associated with SCD; (7) feeling of worse performance than others of the same age group. Receives: Diagnostic Test: Multi-omics features extraction | |
| Mild cognitive impairment (MCI) group | (1) having impaired scores on both measures in at least one cognitive domain (memory, language, or speed/executive function); (2) having impaired scores in each of the three cognitive domains (memory, language, or speed/executive function); (3) the Functional Activities Questionnaire (FAQ)≥9. | |
| AD dementia group | (1) meet the criteria for dementia and have impaired daily functional activities; (2) episodic memory deficit; 3) Clinical Dementia Rating (CDR) ≥ 1. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The changes of gut microbiome in the spectrum of AD
Using the 16S rRNA Illumina Miseq sequencing technique, the diversity and compositions of gut microbiome will be compared in different stages of AD, including cognitively normal individuals, SCD, MCI and AD dementia.
Measured: 5 year
The changes of SCFAs in the spectrum of AD
Using the high-throughput target metabolomics technique, SCFAs will be compared in different stages of AD, including cognitively normal individuals, SCD, MCI and AD dementia.
Measured: 5 year
Multi-omics biomarkers associated with conversion to cognitive impairment for SCD subjects
SCD subjects will be followed for five years. The investigators aim to characterize those who convert to MCI or AD dementia during the follow-up, and further find the multi-omics features associated with the progression of AD. Based on multi-omics features extracted from clinical data, gut microbiome, metabolomics, and multi-modal MRI, the diagnostic model of SCD due to preclinical AD will be established.
Measured: 5 years
Secondary outcomes (1)
The interaction mechanisms of "gut microbiota-SCFAs-brain networks"
The gut microbiome, SCFAs and multi-modal MRI techniques will be combined to elucidate potential interaction mechanisms of "gut microbiota-SCFAs-brain networks".
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 posted20 Feb 2025
- Study start1 Jan 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies 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
- 285 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Jining Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Xuanwu Hospital, Beijing
- Responsible party
- Principal investigator, Can Sheng, Jining Medical University
- Investigators
- Can Sheng, PhD, Principal investigator, Affiliated Hospital of Jining Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06837272
- Sponsor's protocol ID
- JiningMU_Shc1
- Status last verified
- Feb 2025
- First submitted
- 15 Feb 2025
- Last updated
- 20 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The information of neuropsychological tests, and other clinical data are to be shared with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Longitudinal Study to Explore the Impact of Gut Microbiome on Brain Health in Alzheimer's Disease: China Healthy Brain and Gut Microbiome Study (CHBGMS)
- ClinicalTrials.gov ID
- NCT06837272
- Acronym / sponsor ID
- JiningMU_Shc1
- Keywords
- Subjective cognitive decline, Multi-omics
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 285 participants (estimated)
- Lead sponsor
- Jining Medical UniversityUniversity, hospital or other
- Collaborators
- Xuanwu Hospital, Beijing
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 20 Feb 2025 (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.
Gut microbiota dysfunction is associated with Alzheimer's disease (AD). However, the potential modulatory mechanism remains unclear. Previous studies have shown that gut-derived metabolites short-chain fatty acids (SCFAs) may be the key mediators between gut microbiota and brain, participating in the modulatory pathway "gut microbiota-SCFAs-brain networks". In this project, high-throughput targeted metabolomics technique will be used to explore the differences of SCFAs in the spectrum of AD, including cognitively normal individuals, subjective cognitive decline (SCD), mild cognitive impairment (MCI), and AD dementia. Then, the gut microbiome and multi-modal MRI techniques will be combined to elucidate potential interaction mechanisms of "gut microbiota-SCFAs-brain networks". Finally, based on multi-omics features extracted from gut microbiome, metabolomics, and neuroimaging after five years, the diagnostic model of SCD due to preclinical AD will be established using machine learning methods.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cognitively normal group | – | –(1) normal performance on standardized cognitive tests; (2) with no cognitive complaints or any concerns (worries). |
| Subjective cognitive decline (SCD) group | – | Diagnostic Test: Multi-omics features extraction(1) self-experienced persistent decline in memory, rather than other domains of cognition; (2) normal performance on standardized cognitive tests; (3) failure to meet the criteria for MCI or dementia; (4) age at onset of SCD ≥ 60 years old; (5) onset of SCD within the last 5 years; (6) concerns (worries) associated with SCD; (7) feeling of worse performance than others of the same age group. |
| Mild cognitive impairment (MCI) group | – | –(1) having impaired scores on both measures in at least one cognitive domain (memory, language, or speed/executive function); (2) having impaired scores in each of the three cognitive domains (memory, language, or speed/executive function); (3) the Functional Activities Questionnaire (FAQ)≥9. |
| AD dementia group | – | –(1) meet the criteria for dementia and have impaired daily functional activities; (2) episodic memory deficit; 3) Clinical Dementia Rating (CDR) ≥ 1. |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Volunteers recruited from both clinical and communities, and signed up with informed consent.
Key inclusion criteria (18 listed)
- Cognitively normal group:
- SCD group:
- MCI group:
- AD dementia group:
Key exclusion criteria (10 listed)
- a history of stroke;
- major depression and anxiety;
- other central nervous system disorders that may cause cognitive impairment, such as Parkinson's disease, tumors, encephalitis, and epilepsy;
- cognitive impairment caused by traumatic brain injury;
- systemic diseases, such as thyroid dysfunction, syphilis and HIV;
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 |
|---|---|---|
| Multi-omics features extractionBased on multi-omics features extracted from clinical data, gut microbiome, metabolomics, and multi-modal MRI, the diagnostic model of SCD due to preclinical AD will be established. | Diagnostic test | Subjective cognitive decline (SCD) group |
Primary outcome
The changes of gut microbiome in the spectrum of AD
Time frame: 5 year
Using the 16S rRNA Illumina Miseq sequencing technique, the diversity and compositions of gut microbiome will be compared in different stages of AD, including cognitively normal individuals, SCD, MCI and AD dementia.
The changes of SCFAs in the spectrum of AD
Time frame: 5 year
Using the high-throughput target metabolomics technique, SCFAs will be compared in different stages of AD, including cognitively normal individuals, SCD, MCI and AD dementia.
Multi-omics biomarkers associated with conversion to cognitive impairment for SCD subjects
Time frame: 5 years
SCD subjects will be followed for five years. The investigators aim to characterize those who convert to MCI or AD dementia during the follow-up, and further find the multi-omics features associated with the progression of AD. Based on multi-omics features extracted from clinical data, gut microbiome, metabolomics, and multi-modal MRI, the diagnostic model of SCD due to preclinical AD will be established.
1 secondary outcome
The interaction mechanisms of "gut microbiota-SCFAs-brain networks"
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 20 Feb 2025.
- Individual participant dataSharing planned: Yes. The information of neuropsychological tests, and other clinical data are to be shared with other researchers.
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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.
Can Sheng, PhD principal investigator
Affiliated Hospital of Jining 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 Alzheimer Disease and Gut Microbiota, run by Jining Medical 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 18 inclusion and 10 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 20 Feb 2025. 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 Can Sheng, PhD (86-18701257298, canyeweiwu2013@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The changes of gut microbiome in the spectrum of AD (time frame: 5 year). The study lists 3 primary outcomes in all. 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 20 Feb 2025.