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Recruiting NCT06837272

A Longitudinal Study to Explore the Impact of Gut Microbiome on Brain Health in Alzheimer's Disease

— Observational Alzheimer Disease Gut Microbiota Metabonomics Magnetic Resonance Imaging

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Multi-omics features extraction.
Who it may be relevant to
Registry conditions: Alzheimer Disease, Gut Microbiota, Metabonomics, Magnetic Resonance Imaging. Basic parameters: 60 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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)

Overview

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.

Interventions

  • Diagnostic test Multi-omics features extraction
    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.

Primary outcome measures

  • The changes of gut microbiome in the spectrum of AD [Time frame: 5 year]
  • The changes of SCFAs in the spectrum of AD [Time frame: 5 year]
  • Multi-omics biomarkers associated with conversion to cognitive impairment for SCD subjects [Time frame: 5 years]
Secondary outcome measures (1)
  • The interaction mechanisms of "gut microbiota-SCFAs-brain networks" [Time frame: 5 years]

Eligibility criteria

Inclusion criteria

  • 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;
  • 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.

Exclusion criteria

  • 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;
  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

China · 1 center
  • Department of Neurolgy, the Affiliated Hospital of Jining Medical University — Jining

Identifiers

NCT: NCT06837272 · JiningMU_Shc1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗