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Microbiome in Aging Gut and Brain (MiaGB) Study

Status: Recruiting
Location: See location...
Study Type: Observational
SUMMARY

The Microbiome in Aging Gut and Brain (MiaGB) Study is an observational study designed to examine whether differences in the microorganisms living in the gut and mouth are associated with cognitive health and cognitive decline. The study includes young healthy adults, cognitively healthy older adults, older adults with mild cognitive impairment (MCI), and older adults with Alzheimer's disease or related dementia. At the baseline visit, participants complete assessments of medical history, cognitive function, physical function, and diet and provide biological samples that may include stool, saliva, oral swabs, blood, and urine. Researchers will study the gut and oral microbiome and related biological factors, including metabolites and markers of intestinal permeability and inflammation, to determine whether these measures differ according to cognitive status. Young healthy adults, cognitively healthy older adults, and participants with MCI will be followed annually for up to 5 years to evaluate changes in the microbiome and cognitive function over time. Participants with Alzheimer's disease or related dementia will participate in the baseline assessment only. No drug, treatment, or other research intervention is assigned as part of this study.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
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• 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.

Locations
United States
Florida
Department of Neurosurgery and Brain and Spine and Faculty of USF Center for Microbiome Re-search, Microbiomes Institute
RECRUITING
Tampa
Contact Information
Primary
Shalini Jain, PhD
jains10@usf.edu
813-974-8222
Time Frame
Start Date: 2021-09-16
Estimated Completion Date: 2031-09
Participants
Target number of participants: 700
Treatments
Young Healthy Adults
Healthy adults aged 18-60 years with normal cognitive function. Participants undergo baseline assessments and annual follow-up for up to 5 years.
Cognitively Healthy Older Adults
Adults aged 60 years and older with normal cognitive function. Participants undergo baseline assessments and annual follow-up for up to 5 years.
Mild Cognitive Impairment (MCI)
Adults aged 60 years and older with mild cognitive impairment. Participants undergo baseline assessments and annual follow-up for up to 5 years.
Alzheimer's Disease/Dementia
Adults aged 60 years and older with Alzheimer's disease or Alzheimer's disease-related dementia. Participants undergo baseline assessment only and are not included in the 5-year longitudinal follow-up.
Related Therapeutic Areas
Sponsors
Leads: University of South Florida

This content was sourced from clinicaltrials.gov