A Longitudinal Study to Explore the Impact of Gut Microbiome on Brain Health in Alzheimer's Disease
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age60-80
SponsorJining Medical University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
normal performance on standardized cognitive tests;
with no cognitive complaints or any concerns (worries).
self-experienced persistent decline in memory, rather than other domains of cognition;
normal performance on standardized cognitive tests;
Disqualifiers
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;
Trial population
Volunteers recruited from both clinical and communities, and signed up with informed consent.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Multi-omics features extraction
Diagnostic testBased 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.
Treatment groups
285 Participants
are divided into 4 treatment groupsGroup A: Cognitively normal group0 interventions
Group B: Subjective cognitive decline (SCD) group1 intervention
Group C: Mild cognitive impairment (MCI) group0 interventions
Group D: AD dementia group0 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
5 year2
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.
Time frame
5 year3
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.
Time frame
5 yearsSecondary 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".
Time frame
5 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Jining Medical University
Lead sponsor
Xuanwu Hospital, Beijing
Collaborator
Source ClinicalTrials.gov