Alzheimer DiseaseNCT05601856
Gut Microbiome and Blood Indices in Patients With AD and Their Spousal Caregivers
An observational study of Alzheimer Disease and Gut Biome, run by University of Virginia at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 65 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Alzheimer Disease, Gut Biome
- How many people
- 104 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Dec 2022to 30 Jul 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 90 years
- All sexes
- Healthy volunteers accepted
- Older adult
Study population: Adults who are at risk for Alzheimer's Disease.
Who may be able to join
- patients with AD whose clinical dementia rating (CDR) is > 1
- Spouses of Patients in the above group Or
- Healthy adult unrelated to groups 1 and 2, with no history of dementia And
- Regardless of the grouping, the prospective subject must be between 65 and 90 years old
Who cannot join
- Familial Alzheimer's Disease (AD)
- Severe cardiovascular disease
- Severe respiratory system disease
- Severe liver disease
- Severe kidney disease
- Severe central nervous system diseases
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University of Virginia
Charlottesville, Virginia, 22908-0710
Keita Ikeda, PhD, 9195931174, keita.ikeda@virginia.edu
Marcia E. Birk, (434) 982-0230, meb2w@hscmail.mcc.virginia.edu
About this study
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.
Read the 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.
- Conditions
- Alzheimer Disease, Gut Biome
- Keywords
- Alzheimers, biome
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Inflammation related biomarkers
interleukin (IL)-1β, IL-6, IL-10, IL-17, complement 3 (C3,) and YKL-40
Measured: one day
amyloid biomarker
amyloid beta (Aβ)1-42
Measured: one day
ratio of Aβ1-42 and Aβ1-40
Measured: one day
total tau biomarker
Measured: one day
phospho-tau at 181 or 217 biomarker
Measured: one day
neurodegeneration related biomarkers
neurofilament light chain (NFL) and neurogranin
Measured: one day
serum short chain fatty acids
acetic acid, propionic acid, isobutyric acid, butyric acid, valeric acid and hexanic acid
Measured: one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2022
- Study start15 Dec 2022
- Primary completion30 Apr 2025 (estimated)
- Study completion30 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (42)Papers the sponsor has linked to this study.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- More trials run by University of VirginiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 104 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Zhiyi Zuo, MD, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05601856
- Sponsor's protocol ID
- HSR220333
- Status last verified
- May 2024
- First submitted
- 27 Oct 2022
- Last updated
- 27 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: If shared, it will be de-identified data.
Publications
Vassar R, Citron M. Abeta-generating enzymes: recent advances in beta- and gamma-secretase research. Neuron. 2000 Sep;27(3):419-22. doi: 10.1016/s0896-6273(00)00051-9. No abstract available.
PubMed 11055423Vassar R. BACE1: the beta-secretase enzyme in Alzheimer's disease. J Mol Neurosci. 2004;23(1-2):105-14. doi: 10.1385/JMN:23:1-2:105.
PubMed 15126696Selkoe DJ. Alzheimer's disease: genes, proteins, and therapy. Physiol Rev. 2001 Apr;81(2):741-66. doi: 10.1152/physrev.2001.81.2.741.
PubMed 11274343Wang WY, Tan MS, Yu JT, Tan L. Role of pro-inflammatory cytokines released from microglia in Alzheimer's disease. Ann Transl Med. 2015 Jun;3(10):136. doi: 10.3978/j.issn.2305-5839.2015.03.49.
PubMed 26207229Saji N, Murotani K, Hisada T, Tsuduki T, Sugimoto T, Kimura A, Niida S, Toba K, Sakurai T. The relationship between the gut microbiome and mild cognitive impairment in patients without dementia: a cross-sectional study conducted in Japan. Sci Rep. 2019 Dec 18;9(1):19227. doi: 10.1038/s41598-019-55851-y.
PubMed 31852995Guo M, Peng J, Huang X, Xiao L, Huang F, Zuo Z. Gut Microbiome Features of Chinese Patients Newly Diagnosed with Alzheimer's Disease or Mild Cognitive Impairment. J Alzheimers Dis. 2021;80(1):299-310. doi: 10.3233/JAD-201040.
PubMed 33523001Wang X, Sun G, Feng T, Zhang J, Huang X, Wang T, Xie Z, Chu X, Yang J, Wang H, Chang S, Gong Y, Ruan L, Zhang G, Yan S, Lian W, Du C, Yang D, Zhang Q, Lin F, Liu J, Zhang H, Ge C, Xiao S, Ding J, Geng M. Sodium oligomannate therapeutically remodels gut microbiota and suppresses gut bacterial amino acids-shaped neuroinflammation to inhibit Alzheimer's disease progression. Cell Res. 2019 Oct;29(10):787-803. doi: 10.1038/s41422-019-0216-x. Epub 2019 Sep 6.
PubMed 31488882Kim MS, Kim Y, Choi H, Kim W, Park S, Lee D, Kim DK, Kim HJ, Choi H, Hyun DW, Lee JY, Choi EY, Lee DS, Bae JW, Mook-Jung I. Transfer of a healthy microbiota reduces amyloid and tau pathology in an Alzheimer's disease animal model. Gut. 2020 Feb;69(2):283-294. doi: 10.1136/gutjnl-2018-317431. Epub 2019 Aug 30.
PubMed 31471351Li B, He Y, Ma J, Huang P, Du J, Cao L, Wang Y, Xiao Q, Tang H, Chen S. Mild cognitive impairment has similar alterations as Alzheimer's disease in gut microbiota. Alzheimers Dement. 2019 Oct;15(10):1357-1366. doi: 10.1016/j.jalz.2019.07.002. Epub 2019 Aug 18.
PubMed 31434623Lai Z, Shan W, Li J, Min J, Zeng X, Zuo Z. Appropriate exercise level attenuates gut dysbiosis and valeric acid increase to improve neuroplasticity and cognitive function after surgery in mice. Mol Psychiatry. 2021 Dec;26(12):7167-7187. doi: 10.1038/s41380-021-01291-y. Epub 2021 Oct 18.
PubMed 34663905Liu H, McPherson BC, Zhu X, Da Costa ML, Jeevanandam V, Yao Z. Role of nitric oxide and protein kinase C in ACh-induced cardioprotection. Am J Physiol Heart Circ Physiol. 2001 Jul;281(1):H191-7. doi: 10.1152/ajpheart.2001.281.1.H191.
PubMed 11406485Colombo AV, Sadler RK, Llovera G, Singh V, Roth S, Heindl S, Sebastian Monasor L, Verhoeven A, Peters F, Parhizkar S, Kamp F, Gomez de Aguero M, MacPherson AJ, Winkler E, Herms J, Benakis C, Dichgans M, Steiner H, Giera M, Haass C, Tahirovic S, Liesz A. Microbiota-derived short chain fatty acids modulate microglia and promote Abeta plaque deposition. Elife. 2021 Apr 13;10:e59826. doi: 10.7554/eLife.59826.
PubMed 33845942Marizzoni M, Cattaneo A, Mirabelli P, Festari C, Lopizzo N, Nicolosi V, Mombelli E, Mazzelli M, Luongo D, Naviglio D, Coppola L, Salvatore M, Frisoni GB. Short-Chain Fatty Acids and Lipopolysaccharide as Mediators Between Gut Dysbiosis and Amyloid Pathology in Alzheimer's Disease. J Alzheimers Dis. 2020;78(2):683-697. doi: 10.3233/JAD-200306.
PubMed 33074224Norton MC, Smith KR, Ostbye T, Tschanz JT, Corcoran C, Schwartz S, Piercy KW, Rabins PV, Steffens DC, Skoog I, Breitner JC, Welsh-Bohmer KA; Cache County Investigators. Greater risk of dementia when spouse has dementia? The Cache County study. J Am Geriatr Soc. 2010 May;58(5):895-900. doi: 10.1111/j.1532-5415.2010.02806.x.
PubMed 20722820Vitaliano PP, Zhang J, Scanlan JM. Is caregiving hazardous to one's physical health? A meta-analysis. Psychol Bull. 2003 Nov;129(6):946-72. doi: 10.1037/0033-2909.129.6.946.
PubMed 14599289
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gut Microbiome and Blood Indices in Patients With AD and Their Spousal Caregivers
- ClinicalTrials.gov ID
- NCT05601856
- Acronym / sponsor ID
- HSR220333
- Conditions
- Alzheimer Disease, Gut Biome
- Keywords
- Alzheimers, biome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 104 participants (estimated)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 15 Dec 2022 (actual)
- Primary completion
- 30 Apr 2025 (estimated)
- Study completion
- 30 Jul 2025 (estimated)
- First posted
- 1 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 65 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- Adults who are at risk for Alzheimer's Disease.
Key inclusion criteria (4 listed)
- patients with AD whose clinical dementia rating (CDR) is > 1
- Spouses of Patients in the above group Or
- Healthy adult unrelated to groups 1 and 2, with no history of dementia And
- Regardless of the grouping, the prospective subject must be between 65 and 90 years old
Key exclusion criteria (15 listed)
- Familial Alzheimer's Disease (AD)
- Severe cardiovascular disease
- Severe respiratory system disease
- Severe liver disease
- Severe kidney disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Inflammation related biomarkers
Time frame: one day
interleukin (IL)-1β, IL-6, IL-10, IL-17, complement 3 (C3,) and YKL-40
amyloid biomarker
Time frame: one day
amyloid beta (Aβ)1-42
ratio of Aβ1-42 and Aβ1-40
Time frame: one day
total tau biomarker
Time frame: one day
phospho-tau at 181 or 217 biomarker
Time frame: one day
neurodegeneration related biomarkers
Time frame: one day
neurofilament light chain (NFL) and neurogranin
serum short chain fatty acids
Time frame: one day
acetic acid, propionic acid, isobutyric acid, butyric acid, valeric acid and hexanic acid
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2025.
- Background: PubMed 11055423Vassar R, Citron M. Abeta-generating enzymes: recent advances in beta- and gamma-secretase research. Neuron. 2000 Sep;27(3):419-22. doi: 10.1016/s0896-6273(00)00051-9. No abstract available.
- Background: PubMed 15126696Vassar R. BACE1: the beta-secretase enzyme in Alzheimer's disease. J Mol Neurosci. 2004;23(1-2):105-14. doi: 10.1385/JMN:23:1-2:105.
- Background: PubMed 11274343Selkoe DJ. Alzheimer's disease: genes, proteins, and therapy. Physiol Rev. 2001 Apr;81(2):741-66. doi: 10.1152/physrev.2001.81.2.741.
- Background: PubMed 26207229Wang WY, Tan MS, Yu JT, Tan L. Role of pro-inflammatory cytokines released from microglia in Alzheimer's disease. Ann Transl Med. 2015 Jun;3(10):136. doi: 10.3978/j.issn.2305-5839.2015.03.49.
- Background: PubMed 31852995Saji N, Murotani K, Hisada T, Tsuduki T, Sugimoto T, Kimura A, Niida S, Toba K, Sakurai T. The relationship between the gut microbiome and mild cognitive impairment in patients without dementia: a cross-sectional study conducted in Japan. Sci Rep. 2019 Dec 18;9(1):19227. doi: 10.1038/s41598-019-55851-y.
- Background: PubMed 33523001Guo M, Peng J, Huang X, Xiao L, Huang F, Zuo Z. Gut Microbiome Features of Chinese Patients Newly Diagnosed with Alzheimer's Disease or Mild Cognitive Impairment. J Alzheimers Dis. 2021;80(1):299-310. doi: 10.3233/JAD-201040.
- Background: PubMed 31488882Wang X, Sun G, Feng T, Zhang J, Huang X, Wang T, Xie Z, Chu X, Yang J, Wang H, Chang S, Gong Y, Ruan L, Zhang G, Yan S, Lian W, Du C, Yang D, Zhang Q, Lin F, Liu J, Zhang H, Ge C, Xiao S, Ding J, Geng M. Sodium oligomannate therapeutically remodels gut microbiota and suppresses gut bacterial amino acids-shaped neuroinflammation to inhibit Alzheimer's disease progression. Cell Res. 2019 Oct;29(10):787-803. doi: 10.1038/s41422-019-0216-x. Epub 2019 Sep 6.
- Background: PubMed 31471351Kim MS, Kim Y, Choi H, Kim W, Park S, Lee D, Kim DK, Kim HJ, Choi H, Hyun DW, Lee JY, Choi EY, Lee DS, Bae JW, Mook-Jung I. Transfer of a healthy microbiota reduces amyloid and tau pathology in an Alzheimer's disease animal model. Gut. 2020 Feb;69(2):283-294. doi: 10.1136/gutjnl-2018-317431. Epub 2019 Aug 30.
- Background: PubMed 31434623Li B, He Y, Ma J, Huang P, Du J, Cao L, Wang Y, Xiao Q, Tang H, Chen S. Mild cognitive impairment has similar alterations as Alzheimer's disease in gut microbiota. Alzheimers Dement. 2019 Oct;15(10):1357-1366. doi: 10.1016/j.jalz.2019.07.002. Epub 2019 Aug 18.
- Background: PubMed 34663905Lai Z, Shan W, Li J, Min J, Zeng X, Zuo Z. Appropriate exercise level attenuates gut dysbiosis and valeric acid increase to improve neuroplasticity and cognitive function after surgery in mice. Mol Psychiatry. 2021 Dec;26(12):7167-7187. doi: 10.1038/s41380-021-01291-y. Epub 2021 Oct 18.
- Background: PubMed 11406485Liu H, McPherson BC, Zhu X, Da Costa ML, Jeevanandam V, Yao Z. Role of nitric oxide and protein kinase C in ACh-induced cardioprotection. Am J Physiol Heart Circ Physiol. 2001 Jul;281(1):H191-7. doi: 10.1152/ajpheart.2001.281.1.H191.
- Background: PubMed 33845942Colombo AV, Sadler RK, Llovera G, Singh V, Roth S, Heindl S, Sebastian Monasor L, Verhoeven A, Peters F, Parhizkar S, Kamp F, Gomez de Aguero M, MacPherson AJ, Winkler E, Herms J, Benakis C, Dichgans M, Steiner H, Giera M, Haass C, Tahirovic S, Liesz A. Microbiota-derived short chain fatty acids modulate microglia and promote Abeta plaque deposition. Elife. 2021 Apr 13;10:e59826. doi: 10.7554/eLife.59826.
- Individual participant dataSharing planned: No. If shared, it will be de-identified data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alzheimer Disease and Gut Biome, run by University of Virginia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Keita Ikeda, PHD (9195931174, keita.ikeda@virginia.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Inflammation related biomarkers (time frame: one day). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05601856, which also lists 42 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2025.