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

March 24, 2025 updated by: Zhiyi Zuo, MD, University of Virginia
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.

Study Overview

Status

Recruiting

Conditions

Detailed 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.

Study Type

Observational

Enrollment (Estimated)

104

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years to 90 years (Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Adults who are at risk for Alzheimer's Disease.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Alzheimer's Patient

patients with AD whose clinical dementia rating (CDR) is > 1 Age 65-90 with none of the criteria below:

  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
Spousal Caregiver to Alzheimer's Patient

Spousal Caregiver to "Alzheimer's Patient" group, Age 65-90 with none of the criteria below:

  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
Healthy adult control

Age-matched to "Spousal Caregiver to Alzheimer's Patient" group Age 65-90 with none of the criteria below:

  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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Inflammation related biomarkers
Time Frame: one day
interleukin (IL)-1β, IL-6, IL-10, IL-17, complement 3 (C3,) and YKL-40
one day
amyloid biomarker
Time Frame: one day
amyloid beta (Aβ)1-42
one day
ratio of Aβ1-42 and Aβ1-40
Time Frame: one day
one day
total tau biomarker
Time Frame: one day
one day
phospho-tau at 181 or 217 biomarker
Time Frame: one day
one day
neurodegeneration related biomarkers
Time Frame: one day
neurofilament light chain (NFL) and neurogranin
one day
serum short chain fatty acids
Time Frame: one day
acetic acid, propionic acid, isobutyric acid, butyric acid, valeric acid and hexanic acid
one day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Virginia

Collaborators

National Institute on Aging (NIA)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 15, 2022

Primary Completion (Estimated)

April 30, 2025

Study Completion (Estimated)

July 30, 2025

Study Registration Dates

First Submitted

October 27, 2022

First Submitted That Met QC Criteria

October 31, 2022

First Posted (Actual)

November 1, 2022

Study Record Updates

Last Update Posted (Actual)

March 27, 2025

Last Update Submitted That Met QC Criteria

March 24, 2025

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HSR220333

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

If shared, it will be de-identified data.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Alzheimer Disease

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Panama

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe