Investigating gut microbiome and blood markers in Alzheimer's patients and their caregivers
Gut Microbiome and Blood Indices in Patients With AD and Their Spousal Caregivers
This study is testing whether the gut health and blood markers of Alzheimer's patients are similar to those of their spousal caregivers to see if caregivers might also be at risk for cognitive decline.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 104 (estimated) |
| Ages | 65 Years to 90 Years |
| Sex | All |
| Sponsor | University of Virginia Academic / other |
| Locations | 1 site (Charlottesville, Virginia) |
| Trial ID | NCT05601856 on ClinicalTrials.gov |
What this trial studies
This observational study aims to explore the gut microbiome and blood indices in patients with Alzheimer's disease (AD) and their spousal caregivers. It hypothesizes that spousal caregivers may exhibit similar gut dysbiosis and inflammatory markers as AD patients, potentially increasing their risk of cognitive decline. The study will recruit three groups: AD patients, their spousal caregivers, and age-matched healthy controls. Participants will undergo assessments of their gut microbiome, blood indices related to neuroinflammation, and cognitive evaluations.
Who should consider this trial
Good fit: Ideal candidates include patients aged 65-90 with a clinical dementia rating greater than 1, their spousal caregivers, and healthy adults of the same age range.
Not a fit: Patients with familial Alzheimer's disease or severe comorbid conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into the shared biological markers between Alzheimer's patients and their caregivers, potentially leading to early interventions for caregivers.
How similar studies have performed: While studies have explored gut microbiome dysfunction in AD patients, this specific approach involving caregivers is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. patients with AD whose clinical dementia rating (CDR) is \> 1 2. Spouses of Patients in the above group Or 3. Healthy adult unrelated to groups 1 and 2, with no history of dementia And 4. Regardless of the grouping, the prospective subject must be between 65 and 90 years old Exclusion Criteria: 1. Familial Alzheimer's Disease (AD) 2. Severe cardiovascular disease 3. Severe respiratory system disease 4. Severe liver disease 5. Severe kidney disease 6. Severe central nervous system diseases 7. Having a lifespan of fewer than 3 months 8. History of psychiatric illness 9. Major neurological diseases other than AD 10. Current use of corticosteroids, antibiotics, or bowel motility modification agents 11. Any history of Alcoholism or illicit drug dependence 12. Previous inclusion in this study 13. Difficulty with follow-up or poor compliance 14. Severe hearing impairment 15. Severe vision impairment
Where this trial is running
Charlottesville, Virginia
- University of Virginia — Charlottesville, Virginia, United States (Recruiting)
Study contacts
- Study coordinator: Keita Ikeda, PHD
- Email: keita.ikeda@virginia.edu
- Phone: 9195931174
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.