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

Sponsor
University of Virginia (Other)
Overall Status
Recruiting
CT.gov ID
NCT05601856
Collaborator
National Institute on Aging (NIA) (NIH)
104
Enrollment
1
Location
23.5
Anticipated Duration (Months)
4.4
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Anticipated Enrollment :
    104 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Gut Microbiome and Blood Indices in Patients With AD and Their Spousal Caregivers
    Actual Study Start Date :
    Dec 15, 2022
    Anticipated Primary Completion Date :
    Nov 30, 2024
    Anticipated Study Completion Date :
    Nov 30, 2024

    Arms and Interventions

    Arm Intervention/Treatment
    Alzheimer's Patient

    patients with AD whose clinical dementia rating (CDR) is > 1 Age 65-90 with none of the criteria below: Familial Alzheimer's Disease (AD) Severe cardiovascular disease Severe respiratory system disease Severe liver disease Severe kidney disease Severe central nervous system diseases Having a lifespan of fewer than 3 months History of psychiatric illness Major neurological diseases other than AD Current use of corticosteroids, antibiotics, or bowel motility modification agents Any history of Alcoholism or illicit drug dependence Previous inclusion in this study Difficulty with follow-up or poor compliance Severe hearing impairment 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: Familial Alzheimer's Disease (AD) Severe cardiovascular disease Severe respiratory system disease Severe liver disease Severe kidney disease Severe central nervous system diseases Having a lifespan of fewer than 3 months History of psychiatric illness Major neurological diseases other than AD Current use of corticosteroids, antibiotics, or bowel motility modification agents Any history of Alcoholism or illicit drug dependence Previous inclusion in this study Difficulty with follow-up or poor compliance Severe hearing impairment 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: Familial Alzheimer's Disease (AD) Severe cardiovascular disease Severe respiratory system disease Severe liver disease Severe kidney disease Severe central nervous system diseases Having a lifespan of fewer than 3 months History of psychiatric illness Major neurological diseases other than AD Current use of corticosteroids, antibiotics, or bowel motility modification agents Any history of Alcoholism or illicit drug dependence Previous inclusion in this study Difficulty with follow-up or poor compliance Severe hearing impairment Severe vision impairment

    Outcome Measures

    Primary Outcome Measures

    1. Inflammation related biomarkers [one day]

      interleukin (IL)-1β, IL-6, IL-10, IL-17, complement 3 (C3,) and YKL-40

    2. amyloid biomarker [one day]

      amyloid beta (Aβ)1-42

    3. ratio of Aβ1-42 and Aβ1-40 [one day]

    4. total tau biomarker [one day]

    5. phospho-tau at 181 or 217 biomarker [one day]

    6. neurodegeneration related biomarkers [one day]

      neurofilament light chain (NFL) and neurogranin

    7. serum short chain fatty acids [one day]

      acetic acid, propionic acid, isobutyric acid, butyric acid, valeric acid and hexanic acid

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    65 Years to 90 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Virginia Charlottesville Virginia United States 22908-0710

    Sponsors and Collaborators

    • University of Virginia
    • National Institute on Aging (NIA)

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Zhiyi Zuo, MD, Professor, Anesthesiology, University of Virginia
    ClinicalTrials.gov Identifier:
    NCT05601856
    Other Study ID Numbers:
    • HSR220333
    First Posted:
    Nov 1, 2022
    Last Update Posted:
    Jan 20, 2023
    Last Verified:
    Jan 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Zhiyi Zuo, MD, Professor, Anesthesiology, University of Virginia
    Alzheimers
    biome
    Additional relevant MeSH terms:
    Alzheimer Disease

    Study Results

    No Results Posted as of Jan 20, 2023