Clinical Safety and Efficacy of Fecal Microbiota Transplantation (FMT) in the Treatment of Alzheimer's Disease

Last updated: April 7, 2025
Sponsor: Shanghai 10th People's Hospital
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

N/A

Treatment

FMT capsule

Clinical Study ID

NCT06920212
FMT-AD
  • Ages 50-85
  • All Genders

Study Summary

To investigate the clinical safety and efficacy of FMT in AD patients, as well as the changes in the gut microbiota of AD patients before and after FMT.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • The patients (aged 50-85 years) exhibited cognitive decline persisting for over sixmonths;

  • Primarily characterized by recent memory impairment and accompanied by reduced dailyliving abilities;

  • MMSE scores ranging from 3 to 26;

  • MRI findings revealed atrophy in the medial temporal lobe, hippocampus, and cerebralcortex, along with widened sulci and fissures.

Exclusion

Exclusion Criteria:

  • Patients were excluded if they had severe visual, hearing, or language impairments;

  • Tumors;

  • hepatic/renal dysfunction.

  • with conditions mimicking AD symptoms-such as normal pressure hydrocephalus,vascular dementia (VD or VaD);

  • Parkinson's disease dementia (PDD)-were also excluded;

  • patients who had participated in clinical drug trials within the past 30 days orconsumed folate and vitamin B12 at doses exceeding twice the recommended intake wereineligible.

Study Design

Total Participants: 30
Treatment Group(s): 1
Primary Treatment: FMT capsule
Phase:
Study Start date:
October 01, 2024
Estimated Completion Date:
December 31, 2025

Connect with a study center

  • Le Wang

    Shanghai,
    China

    Site Not Available

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