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)

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Observational
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 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
Participation Requirements
Sex: All
Minimum Age: 60
Maximum Age: 80
Healthy Volunteers: t
View:

• 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.

Locations
Other Locations
China
Department of Neurolgy, the Affiliated Hospital of Jining Medical University
RECRUITING
Jining
Contact Information
Primary
Can Sheng, PhD
canyeweiwu2013@163.com
86-18701257298
Backup
Yun Guo, Master
yun125985@163.com
86-18863030588
Time Frame
Start Date: 2024-01-01
Estimated Completion Date: 2029-12-31
Participants
Target number of participants: 285
Treatments
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.
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.
Related Therapeutic Areas
Sponsors
Collaborators: Xuanwu Hospital, Beijing
Leads: Jining Medical University

This content was sourced from clinicaltrials.gov