Clinical trial NCT05601856: Gut Microbiome and Blood Indices in Patients With AD and Their Spousal Caregivers
Official title: Gut Microbiome and Blood Indices in Patients With AD and Their Spousal Caregivers
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Alzheimer Disease
Gut Biome
Keywords: Alzheimers
biome
Lead sponsor: University of Virginia
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2022-11-01
Enrollment: 104
Sex: ALL
Minimum age (years): 65
Maximum age (years): 90
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults who are at risk for Alzheimer's Disease.

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.

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.

Eligibility 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

Primary outcomes:
measure: Inflammation related biomarkers
timeFrame: one day
measure: amyloid biomarker
timeFrame: one day
measure: ratio of Aβ1-42 and Aβ1-40
timeFrame: one day
measure: total tau biomarker
timeFrame: one day
measure: phospho-tau at 181 or 217 biomarker
timeFrame: one day
measure: neurodegeneration related biomarkers
timeFrame: one day
measure: serum short chain fatty acids
timeFrame: one day
Secondary outcomes:
Other outcomes:
Locations:
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
Study officials:
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