90 Participants Needed

Brain Health & the Microbiome

(bMicrobiome Trial)

Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: George Washington University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

This trial is studying how lifestyle changes, like diet and exercise, affect the gut bacteria of healthy people, those with Mild Cognitive Impairment (MCI), and those with early Alzheimer's disease. Researchers want to see if these changes can help improve brain health or slow down memory loss. By understanding these effects, they hope to find new ways to prevent or treat cognitive decline.

Eligibility Criteria

Inclusion Criteria

You have been diagnosed with Early Alzheimer's Disease.
You have been diagnosed with Mild Cognitive Impairment.
Age 50-90
See 1 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Initial assessment of gut microbiome composition and function using shotgun metagenomics

1 week

Intervention

Participants undergo lifestyle changes including diet, probiotics, and physical activity to modify gut microbiome

6 months

Follow-up

Participants are monitored for changes in gut microbiome diversity and function after intervention

3-6 months

Treatment Details

Participant Groups
3Treatment groups
Experimental Treatment
Group I: Mild Cognitive ImpairmentExperimental Treatment1 Intervention
Males and females with mild cognitive impairment, ages 50-90
Group II: Healthy ControlsExperimental Treatment1 Intervention
Healthy males and females, ages 50-90
Group III: Early Alzheimer's DiseaseExperimental Treatment1 Intervention
Males and females with early Alzheimer's disease, ages 50-90

Find a Clinic Near You

Who Is Running the Clinical Trial?

George Washington University

Lead Sponsor

Trials
263
Recruited
476,000+
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