Status:
RECRUITING
A Longitudinal Study to Explore the Impact of Gut Microbiome on Brain Health in Alzheimer's Disease
Lead Sponsor:
Jining Medical University
Collaborating Sponsors:
Xuanwu Hospital, Beijing
Conditions:
Alzheimer Disease
Gut Microbiota
Eligibility:
All Genders
60-80 years
Brief 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-chai...
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
Key Trial Info
Start Date :
January 1 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2029
Estimated Enrollment :
285 Patients enrolled
Trial Details
Trial ID
NCT06837272
Start Date
January 1 2024
End Date
December 31 2029
Last Update
February 20 2025
Active Locations (1)
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1
Department of Neurolgy, the Affiliated Hospital of Jining Medical University
Jining, Shandong, China, 272029