Microbiome in aging gut and brain (MiaGB) study

  • STATUS
    Recruiting
  • End date
    Dec 31, 2026
  • sponsor
    Florida Department of Health
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Updated on 2 May 2023
See if I qualify
cognitive impairment
alzheimer's disease
cognitive decline
mild cognitive impairment
Online studies
Accepts healthy volunteers

Summary

The Microbiome in aging of Gut and Brain study aims to determine how the microbiome impacts our brain health during aging continuum, and how our dietary habits are linked with it. In this study, we plan to recruit 60 years or older subjects with normal cognition, mild cognitive impairment (MCI) and Alzheimer's disease (AD) or its related dementia. We plan to collect medical history with quality of life questionnaires, a battery of cognitive function, saliva and stool samples, along with optional physical function, EEG and blood samples. This is a once in a year participation study with no intervention, but will check cognitive function, microbiome and blood profiles yearly basis. The participation is fully confidential and data is secured as per IRB and HIPAA compliance. Study aims to define the microbiome and gut health related markers to early detect risk of cognitive decline and dementia.

Description

This study is simple non invasive which require participation for two hours once in a year, in which we will enroll older adults (>60 years of age) of 200 cognitive healthy, 100 mild cognitive impairment (MCI) and 100 Alzheimer’s disease (AD) / dementia, and will collect demographic, medical health, cognitive function, physical function, EEG and diet information along with blood and microbiome samples (stools and saliva) at baseline (visit 1). Then further we we will follow the 200 cognitively healthy and 100 mild cognitive impaired (MCI) enrolled in year 1 for 5 years to determine their progression towards MCI and AD. We plan to collect medical history with quality of life questionnaires, a battery of cognitive function, saliva and stool samples, along with optional physical function and blood samples analyses each year, to determine whether microbiome can predict the progression of MCI and AD during this longitudinal follow-up period. The subjects will be recruited from five locations including University of South Florida (USF) as main site. Four locations are University of Central Florida, Florida Atlantic University, University of North Florida and The Miami Jewish Health.

Details
Condition Dementia, Mild Cognitive Impairment, *Healthy Volunteers, Alzheimer's Disease
Clinical Study IdentifierTX310353
SponsorFlorida Department of Health
Last Modified on2 May 2023

Eligibility

 Yes No Not Sure

Inclusion Criteria

Age 60 years and above
Subjects with a. With normal cognition b. Mild cognitive impairment c. Alzheimer’s Disease related dementia
Participants who can provide informed consent

Exclusion Criteria

Individuals under the age of 50
Individuals not experiencing memory or other cognitive complaints
Individuals with a known medical, neurological or psychiatric diagnosis that may explain their current cognitive complaints (e.g., stroke)
Individuals who meet criteria for dementia
Individuals with a history of recent or current substance abuse
Individuals with severe vision or hearing difficulties
Individuals not willing to use a memory and management aid app
informants under the age of 18
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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