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:

    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

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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Department of Neurolgy, the Affiliated Hospital of Jining Medical University

Jining, Shandong, China, 272029