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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Virginia

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 15, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 30, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 30, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 27, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 31, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 1, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 27, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 24, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings