NCT06920212 · ACTIVE NOT RECRUITING
Clinical Safety and Efficacy of Fecal Microbiota Transplantation (FMT) in the Treatment of Alzheimer's Disease
This trial is testing whether fecal microbiota transplantation (FMT) — swallowing capsules containing gut bacteria from healthy donors — can help people already living with Alzheimer's disease. Researchers want to know if it is safe and whether it improves cognition, and they will track changes in patients' gut bacteria before and after treatment. This is a Phase NA (not a standard drug phase) exploratory trial, meaning it is early and investigational, not a proven therapy.
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're excluded 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.
The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.
Eligibility criteria as of 2025-04-09