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

NCT06920212 | Active Not Recruiting

• 1 other identifier: FMT-AD
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Fecal Microbiota Transplantation

Outcome Measures

Primary Outcomes (5)

• Efficacy endpoints

  Changes in scores on the Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog)

  0, 1month, 2months, 3months, 6months

• Efficacy endpoints

  Changes in scores on Mini-Mental State Examination (MMSE).

  0, 1month, 2months, 3months, 6months

• Efficacy endpoints

  Changes in scores on Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change (ADAS-CGIC).

  0, 1month, 2months, 3months, 6months

• Efficacy endpoints

  Changes in scores on Alzheimer's Disease Activities of Daily Living Scale (ADAS-ADL)

  0, 1month, 2months, 3months, 6months

• Changes in gut microbiota

  Gut metagenomic sequencing was performed to conduct OTU (Operational Taxonomic Unit) clustering and taxonomic analysis, comparing alterations in patients' intestinal flora before and after FMT.

  0, 1month, 2months, 3month, 6months

Study Arms (1)

FMT

EXPERIMENTAL

Procedure: FMT capsule

Interventions

FMT capsule PROCEDURE

Fecal microbiota transplantation (FMT) is a method for treating imbalances in the intestinal microbiota. Its basic principle involves extracting a portion of feces from a healthy individual that contains a diverse population of beneficial bacteria, processing it, and transplanting it into the digestive system of the recipient to restore a balanced intestinal microbiota.

FMT

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The patients (aged 50-85 years) exhibited cognitive decline persisting for over six months;
• Primarily characterized by recent memory impairment and accompanied by reduced daily living abilities;
• MMSE scores ranging from 3 to 26;
• MRI findings revealed atrophy in the medial temporal lobe, hippocampus, and cerebral cortex, along with widened sulci and fissures.

You may not qualify if:

• 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 or consumed folate and vitamin B12 at doses exceeding twice the recommended intake were ineligible.

Sponsors & Collaborators

• Shanghai 10th People's Hospital: lead

Study Sites (1)

Le Wang

Shanghai, China

Location

MeSH Terms

Interventions

Fecal Microbiota Transplantation

Intervention Hierarchy (Ancestors)

Biological Therapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dean of the hospital

Study Record Dates

• First Submitted: March 31, 2025
• First Posted: April 9, 2025
• Study Start: October 1, 2024
• Primary Completion: October 31, 2025
• Study Completion: December 31, 2025
• Last Updated: April 9, 2025

Record last verified: 2025-04

Locations

CN (1)