What is this study trying to find out about Alzheimer's disease?

This study is exploring how gut bacteria and their metabolites, especially short-chain fatty acids, interact with the brain in Alzheimer's disease. Researchers aim to understand these connections to improve early diagnosis and tracking of disease progression. The study is sponsored by Jining Medical University and follows participants over several years to gather detailed data.

Who may be eligible for this Alzheimer's disease clinical trial?

Adults aged 60 to 80 with varying cognitive status, including normal cognition, subjective memory decline, mild cognitive impairment, or Alzheimer's dementia, may be eligible. The study accepts all genders and excludes those with certain neurological or gastrointestinal conditions. Please review eligibility criteria for more details.

Is there any cost to participate in this Alzheimer's disease clinical trial?

Study-related care, including tests and visits, is provided at no cost. However, personal travel and related expenses may vary and are not guaranteed to be covered. Participants should plan accordingly for any additional costs.

Actively Recruiting

Age: 60Years - 80Years

All Genders

Healthy Volunteers

ID06837272

A Longitudinal Study to Explore the Impact of Gut Microbiome on Brain Health in Alzheimers Disease China Healthy Brain and Gut Microbiome Study CHBGMS

Led by Jining Medical University · Updated on 2025-02-20

285

Participants Needed

Research Sites

156 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are investigating the relationship between gut microbiota dysfunction and Alzheimers disease AD, focusing on how gut-derived short-chain fatty acids SCFAs may influence brain function through the gut microbiota-SCFAs-brain networks pathway. This observational study will explore differences in SCFAs among people across the AD spectrum, including cognitively normal individuals, those with subjective cognitive decline SCD, mild cognitive impairment MCI, and AD dementia. The project aims to clarify the interactions between gut microbiome, metabolites, and brain changes using high-throughput metabolomics and multi-modal MRI techniques. Participants will be grouped into four categories cognitively normal, SCD, MCI, and AD dementia. The study involves collecting multi-omics data, including gut microbiome analysis, metabolomics, and neuroimaging, to establish a diagnostic model for SCD due to preclinical AD using machine learning methods. The study spans five years, during which gut microbiome changes, SCFAs levels, and multi-omics biomarkers related to cognitive impairment conversion will be monitored. Participants will undergo cognitive tests and brain imaging scans, along with gut microbiome and metabolite sample collection. Researchers will assess the interaction mechanisms of the gut microbiota-SCFAs-brain networks over five years. The study includes both healthy volunteers and patients aged 60 to 80. Outcome measures focus on changes in gut microbiome, SCFAs, and biomarkers linked to cognitive decline, with long-term follow-up to better understand the disease progression and its early detection.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 60Years - 80Years

All Genders

Healthy Volunteers

Eligibility Criteria

You may qualify if you...

Cognitively normal participants with normal cognitive test performance and no memory complaints or concerns
Participants with subjective cognitive decline (SCD) who have persistent memory decline, normal cognitive tests, no dementia or MCI, onset at age 60 or older within the last 5 years, with worries about their memory
Participants with mild cognitive impairment (MCI) showing impaired scores in one or more cognitive domains and Functional Activities Questionnaire score of 9 or higher
Participants with Alzheimer's dementia meeting dementia criteria, impaired daily function, episodic memory deficit, and Clinical Dementia Rating of 1 or higher
Age between 60 and 80 years

You will not qualify if you...

History of stroke
Major depression or anxiety
Other central nervous system disorders causing cognitive impairment such as Parkinson's disease, tumors, encephalitis, or epilepsy
Cognitive impairment caused by traumatic brain injury
Systemic diseases like thyroid dysfunction, syphilis, or HIV
Psychosis or congenital mental developmental delay
Use of antibiotics, probiotics, prebiotics, or synbiotics within the last 3 months
Use of corticosteroids, immune stimulating medications, or immunosuppressive agents
Major gastrointestinal surgery in the past 5 years
Severe gastrointestinal diseases including irritable bowel syndrome, inflammatory bowel disease, severe gastritis, or other digestion and absorption dysfunctions affecting gut microbiota

Research Team

Can Sheng, PhD

Yun Guo, Master

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