Exploring how gut microbiome affects brain health in Alzheimer's disease

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)

This study is trying to see how the bacteria in our gut might affect brain health in people with Alzheimer's disease and related memory issues.

Quick facts

• Study type: Observational
• Enrollment: 285 (estimated)
• Ages: 60 Years to 80 Years
• Sex: All
• Sponsor: Jining Medical University (Academic / other)
• Locations: 1 site (Jining, Shandong)
• Trial ID: NCT06837272 on ClinicalTrials.gov

What this trial studies

This observational study investigates the relationship between gut microbiota and brain health in individuals with Alzheimer's disease and related cognitive conditions. It utilizes high-throughput targeted metabolomics to analyze short-chain fatty acids (SCFAs) across different cognitive states, including cognitively normal individuals, those with subjective cognitive decline, mild cognitive impairment, and Alzheimer's dementia. The study combines gut microbiome analysis with multi-modal MRI techniques to uncover potential interactions within the 'gut microbiota-SCFAs-brain networks'. Over five years, the research aims to develop a diagnostic model for subjective cognitive decline linked to preclinical Alzheimer's disease using machine learning.

Who should consider this trial

Good fit: Ideal candidates include cognitively normal individuals, those experiencing subjective cognitive decline, patients with mild cognitive impairment, and individuals diagnosed with Alzheimer's dementia.

Not a fit: Patients with significant cognitive impairment not meeting the criteria for mild cognitive impairment or dementia may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to new diagnostic tools and therapeutic strategies for early intervention in Alzheimer's disease.

How similar studies have performed: While the relationship between gut microbiota and brain health is being explored, this specific approach combining multi-omics and MRI is relatively novel and has not been extensively tested.

Eligibility criteria

Inclusion Criteria:

* Cognitively normal group:

  1. normal performance on standardized cognitive tests;
  2. with no cognitive complaints or any concerns (worries).
* 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.
* 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.

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

Where this trial is running

Jining, Shandong

• Department of Neurolgy, the Affiliated Hospital of Jining Medical University — Jining, Shandong, China (Recruiting)

Study contacts

• Principal investigator: Can Sheng, PhD — Affiliated Hospital of Jining Medical University
• Study coordinator: Can Sheng, PhD

Conditions Alzheimer Disease; Gut Microbiota; Metabonomics; Magnetic Resonance Imaging; Subjective cognitive decline; Multi-omics