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Gut bacteria may hold clues to memory decline

NCT ID NCT07799402

Knowledge-focused Sponsor: University of South Florida Source: ClinicalTrials.gov ↗

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
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Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
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Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 02, 2026 · Last updated Sep 03, 2026 · Updated 1 time

Summary

Researchers at the University of South Florida are studying whether the microorganisms in the gut and mouth differ between people with healthy brains and those with memory problems. The study will compare young adults, healthy older adults, people with mild cognitive impairment, and people with Alzheimer's disease or related dementia. Participants provide stool, saliva, blood, and urine samples and complete memory and physical tests. Healthy adults and those with mild impairment are followed for up to 5 years to see how their microbiome and thinking change over time.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If the study finds clear links between gut or mouth microbes and cognitive decline, it could point toward new ways to predict or slow memory loss in aging.
What could go wrong
This is an observational study, so it cannot prove that microbes cause cognitive decline. Many other factors, like diet and genetics, also play a role, and the findings may not lead to any treatment.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 700 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2021

Expected to finish

Sep 2031

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

The study population includes young healthy adults aged 18-60 years and adults aged 60 years and older who are cognitively healthy or have mild cognitive impairment (MCI) or Alzheimer's disease/related dementia. Participants are recruited from participating clinical sites, memory and behavioral health clinics, senior living communities, and the community. The planned enrollment is 700 participants: 100 young healthy adults, 300 cognitively healthy older adults, 200 participants with MCI, and 100 participants with Alzheimer's disease/related dementia.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: Age 18-60 years for young healthy participants, or age 60 years and older for older adult participants. Participants meeting one of the following cognitive categories: Normal cognitive function Mild cognitive impairment (MCI) Alzheimer's disease or Alzheimer's disease-related dementia Able to participate in the informed consent process as applicable. For participants unable to provide informed consent because of cognitive impairment, consent may be obtained from a legally authorized representative (LAR) according to the approved protocol. Exclusion Criteria: History of brain or gastrointestinal surgery within the past 5 years. History of cancer and/or cancer treatment within the past 5 years, except non-melanoma skin cancer. History of systemic cancer treatment within the past 5 years. Neurological disorders including epilepsy, Parkinson's disease, or amyotrophic lateral sclerosis. Antibiotic use within the past 30 days. Diarrhea, vomiting, and/or food poisoning within the past 30 days. History of inflammatory bowel disease. Body mass index (BMI) greater than 45 kg/m² or less than 18 kg/m². Weight loss of more than 10 pounds within the past 2 weeks.

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Conditions

The condition(s) this trial relates to.

Alzheimer disease Cognitive Dysfunction dementia Inflammation

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Alzheimer disease (AD) Dementia Mild cognitive impairment

How to take part

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  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

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Contacts and locations

Locations

  • Department of Neurosurgery and Brain and Spine and Faculty of USF Center for Microbiome Re-search, Microbiomes Institute

    RECRUITING

    Tampa, Florida, 33612, United States

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