Status:
ACTIVE_NOT_RECRUITING
Clinical Safety and Efficacy of Fecal Microbiota Transplantation (FMT) in the Treatment of Alzheimer's Disease
Lead Sponsor:
Shanghai 10th People's Hospital
Conditions:
Fecal Microbiota Transplantation
Eligibility:
All Genders
50-85 years
Phase:
NA
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.
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
October 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06920212
Start Date
October 1 2024
End Date
December 31 2025
Last Update
April 9 2025
Active Locations (1)
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1
Le Wang
Shanghai, China