Gut Microbiome and Blood Indices in Patients With AD and Their Spousal Caregivers

Alzheimer Disease Clinical Trial

Official title:

Gut Microbiome and Blood Indices in Patients With AD and Their Spousal Caregivers

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05601856
• Other study ID #: HSR220333
• Status: Recruiting
• Start date: December 15, 2022
• Est. completion date: November 30, 2024

Study information

• Verified date: May 2024
• Source: University of Virginia
• Contact: Keita Ikeda, PHD
• Phone: 9195931174
• Email: keita.ikeda[@]virginia.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Spousal caregivers of Alzheimer's Dementia (AD) patients have an elevated risk of developing AD in the future. Past studies have shown the presence of serum indicators correlated with gut biome dysfunction in AD patients. We hypothesize that the same gut biome dysfunction may be present in spousal caregivers of AD patients.

Description:

Patients with Alzheimer's disease (AD) have gut dysbiosis. Short-chain fatty acids (SCFAs) are products of the gut microbiome. Among them, Acetate and valeric acid were positively correlated with the Aβ plaque load detected by amyloid PET in participants with or without AD. However, the levels of SCFAs in the blood of patients with AD have not been defined. Also, the usefulness of indices of inflammation and neuropathology in the blood as biomarkers for cognitive impairment in patients with AD is elusive. Importantly, spousal caregivers of patients with dementia have a higher risk of developing dementia later in life than those whose spouses do not have dementia. The spousal caregivers have an accelerated cognitive decline. The mechanisms for these phenomena are not known. We hypothesize that spousal caregivers of patients with AD have gut microbiome and levels of blood SCFAs similar to those of patients with AD, that these spouses have increased inflammatory cytokines and indices of AD-like neuropathology in the blood, and that there is a correlation between the cognition and various indices in the blood among patients with AD, their spouses, and age-matched controls. To address these hypotheses, we will recruit three groups of participants: Patients with AD, their spousal caregivers, and controls that are age-matched with the caregivers. Their gut microbiome and indices of neuroinflammation and neuropathology in the blood will be determined. Their cognition will be assessed. The correction of cognition with gut microbiome genera or indices in the blood will be analyzed. Our studies may represent the first study to determine whether the gut microbiome and SCFAs may play a role in the cognitive impairment in the spousal caregivers of patients with AD. These studies may also identify biomarkers for cognitive impairment in these caregivers and patients with AD. These findings may ultimately help the care of patients with AD and reduce the cognitive declines in spousal caregivers of patients with AD.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 104
• Est. completion date: November 30, 2024
• Est. primary completion date: November 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Alzheimer Disease

Locations

Country	Name	City	State
United States	University of Virginia	Charlottesville	Virginia

Sponsors (2)

Lead Sponsor	Collaborator
University of Virginia	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

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* Note: There are 42 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Inflammation related biomarkers	interleukin (IL)-1ß, IL-6, IL-10, IL-17, complement 3 (C3,) and YKL-40	one day
Primary	amyloid biomarker	amyloid beta (Aß)1-42	one day
Primary	ratio of Aß1-42 and Aß1-40		one day
Primary	total tau biomarker		one day
Primary	phospho-tau at 181 or 217 biomarker		one day
Primary	neurodegeneration related biomarkers	neurofilament light chain (NFL) and neurogranin	one day
Primary	serum short chain fatty acids	acetic acid, propionic acid, isobutyric acid, butyric acid, valeric acid and hexanic acid	one day