NCT06278688 · NOT YET RECRUITING
Precision Probiotic Supplementation in Individuals With Mild Cognitive Impairment
This trial is testing whether a personalized probiotic supplement — chosen based on each person's own gut bacteria profile — can slow cognitive decline in people who already have mild cognitive impairment linked to Alzheimer's biology. Participants take the probiotic or a placebo daily for 12 months, with cognitive testing at 6 and 12 months. This is a Phase NA randomized controlled trial, meaning it is a formal efficacy test but not a standard drug-approval phase.
You may qualify if
- 60 years old and above
- Diagnosis of MCI based on 2011 NIA-AA criteria
- Amyloid (+) measured by either amyloid PET imaging or CSF amyloid markers
- No dietary supplements, including other probiotics, yogurts with live, active cultures or supplements, and immune-enhancing supplements in the past three months (or wash-out period for three months for individuals taking supplements)
- No use of antibiotics, anti-inflammatory medications, gastrointestinal medicine within the past three months (or wash-out period for three months for individuals taking medications)
- Consenting to be randomly assigned intervention
You're excluded if
- Currently undergoing cancer treatment.
- The anticipated life expectancy of less than six months.
- Suffering from severe mental disorders such as schizophrenia, bipolar disorder, or major depressive disorder.
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 2024-02-26