Microbiome in Aging of Gut and Brain
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of South Florida
About this trial
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 criteria
This trial accepts healthy volunteersQualifiers
Age 18-60 years for young healthy participants, or age 60 years and older for older adult participants.
Normal cognitive function
Mild cognitive impairment (MCI)
Alzheimer's disease or Alzheimer's disease-related dementia
Disqualifiers
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.
Trial population
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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
700 Participants
are grouped into 4 trial groupsGroup A: Young Healthy Adults
Group B: Cognitively Healthy Older Adults
Group C: Mild Cognitive Impairment (MCI)
Group D: Alzheimer's Disease/Dementia
Trial outcomes
Primary outcomes
1
Gut Microbiome Shannon Diversity Index
Gut microbiome alpha diversity will be quantified from stool samples using the Shannon diversity index. At baseline, Shannon diversity will be assessed across young healthy adults, cognitively healthy older adults, participants with mild cognitive impairment (MCI), and participants with Alzheimer's disease/dementia. Young healthy adults, cognitively healthy older adults, and participants with MCI will also be assessed annually to evaluate longitudinal changes in gut microbiome diversity. Participants with Alzheimer's disease/dementia will undergo baseline assessment only.
Time frame
Baseline for all participants and annually for up to 5 years for longitudinally followed participantsSecondary outcomes
1
Montreal Cognitive Assessment (MoCA) Score
Cognitive function will be assessed using the Montreal Cognitive Assessment (MoCA). MoCA scores will be assessed at baseline across the study groups. Young healthy adults, cognitively healthy older adults, and participants with mild cognitive impairment (MCI) will also be assessed annually to evaluate longitudinal changes in cognitive function. Participants with Alzheimer's disease/dementia will undergo baseline assessment only.
Time frame
Baseline for all participants and annually for up to 5 years for longitudinally followed participantsSponsors and contacts
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Source ClinicalTrials.gov