Mild Cognitive ImpairmentbMicrobiomeNCT06039267
Brain Health & the Microbiome
An observational study of Mild Cognitive Impairment and Mild Dementia, run by George Washington University at 1 site in United States.
Trial summary
The GW SMHS supports research in complementary and integrative approaches to treatment of sickness and disease and for health promotion. Sometimes, research may involve asking questions of patients, students, and health providers. Read more about this study
- Who is it for?
- Ages 50 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Mild Cognitive Impairment, Mild Dementia, Alzheimer Disease 1
- What is being tested?
- Gut Microbiome Testing
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Aug 2023to 24 Aug 2025
- Phase
- Observational
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 50 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Residents of the greater Washington, DC Metro Area.
Who may be able to join
- Age 50-90
- Early Alzheimer's Disease (eAD)
- Mild Cognitive Impairment (MCI)
- Healthy Control (no eAD or MCI)
Who cannot join
- Criteria or pathology that may affect the outcomes of the study or the risk/benefit ratio as determined by the study team
Trial locations and contacts
1 site in 1 country.
United States1 site
George Washington University School of Medicine & Health Sciences
Washington D.C., District of Columbia, 20037
About this study
Official title: Brain Health & the Microbiome: A Proof-of-Concept Study in Patients With Mild Cognitive Impairment
The GW SMHS supports research in complementary and integrative approaches to treatment of sickness and disease and for health promotion. Sometimes, research may involve asking questions of patients, students, and health providers. In this study, individuals are being asked to participate in this study as either 1) a healthy volunteer, 2) a person with Mild Cognitive Impairment (MCI), or 3) a person with early Alzheimer's disease (eAD). We are trying to learn more about if the gut microbiome (the microbes that live in our digestive tract) of individuals with eAD, MCI, and healthy controls are altered following lifestyle changes. This research will provide the pilot data to begin to understand if these changes in the gut microbiome are beneficial to health and/or may slow or halt the progression of MCI or early Alzheimer's.
Read the detailed description
AD is, in a word, devastating. The massive psychological and physical trauma experienced by people with dementia and their loved ones is catastrophic and incapable of overestimation. It is incumbent upon researchers and clinicians to not only better understand the etiology of this disease, but also to translate this knowledge into actionable evidence to facilitate clinical care and prevention. The MGBA serves as a major etiological factor, in both cause and potentiation of the disease process, that possesses great potential for intervention. Interventions have the greatest opportunity for success earlier in the disease pathogenesis; therefore, MCI is an ideal target for intervention to prevent progression to AD. To effectively apply knowledge of this bidirectional relationship, a clearer picture of dysbiosis relevant to cognitive decline must be identified. The inclusion of HC, MCI, and early AD allows for the detection of a dose-response relationship, which is one of Bradford Hill's criteria for causality. 1 This means we will begin to investigate causality (using one of Hill's eight criteria) in addition to association in this proof-of-concept study.
Most previous research has been done at too high a phylogenetic level to be truly informative in terms of interventions-in other words the data is too low resolution. The microbiome field was launched at the phylum/genus level for many reasons including the need to start somewhere in such a complex system. To put this in perspective, comparing a genus, such as Lactobacillus, would be akin to comparing a compilation or average of all species of the genus Homo: H. sapiens, H. habilis, H. errectus, H. heigelbergensis, H. neanderthalensis, and H. naledi. The diversity in Homo sapiens alone is staggering. How could we possibly think this is specific or high resolution enough to be clinically meaningful? Well, the research has shown that it is not. This coupled with advancements in technology (qPCR to 16S to shotgun metagenomics) has changed the landscape of the microbiome field. However, such advanced testing and understanding has yet to make it to the clinic and has largely not been applied to MCI or AD populations to date.
The sum of the evidence suggests that restoration of the gut microbiome may serve to prevent, slow, or even reverse MCI/AD. Whether this entails the use of diet, supplements, medications, etc. or some combination thereof remains to be discovered. Before an intervention can be designed, a firm grasp of the specific alterations to the gut microbiome must be identified using higher resolution than simply genus alone-we must understand species level at least, ideally strain level in many cases. Once we understand the species-level alterations, therapeutic interventions may then be implemented to determine the effect size of said interventions.
- Being tested
- Gut Microbiome Testing
- Medical subject headings
- Cognitive Dysfunction, Alzheimer disease type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gut Microbiome TestingOther
Stool microbiome testing using shotgun metagenomic sequencing
| Study group | Role | What they receive |
|---|---|---|
| Healthy Controls | Healthy males and females, ages 50-90 Receives: Other: Gut Microbiome Testing | |
| Mild Cognitive Impairment | Males and females with mild cognitive impairment, ages 50-90 Receives: Other: Gut Microbiome Testing | |
| Early Alzheimer's Disease | Males and females with early Alzheimer's disease, ages 50-90 Receives: Other: Gut Microbiome Testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gut Microbiome Composition
To compare the gut microbiomes of patients with early Alzheimer's disease, mild cognitive impairment, and healthy controls using diversity as well as genus, species, and strain level differences in composition (shotgun metagenomics).
Measured: 3- and 6-months
Gut Microbiome Function
To compare the gut microbiomes of patients with early Alzheimer's disease, mild cognitive impairment, and healthy controls using diversity as well as genus, species, and strain level differences in function (shotgun metagenomics).
Measured: 3- and 6-months
Document microbiome changes following lifestyle changes in subjects with early Alzheimer's disease, mild cognitive impairment, and healthy controls for future study design.
Observationally collect gut microbiome and lifestyle changes to inform the design of a trial to study lifestyle interventions.
Measured: 3- and 6-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2023
- Study start25 Aug 2023
- Primary completion24 Aug 2025
- Study completion24 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- 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
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- George Washington University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06039267
- Sponsor's protocol ID
- NCR234792
- Acronym
- bMicrobiome
- Status last verified
- Jan 2026
- First submitted
- 31 Aug 2023
- Last updated
- 29 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan to share.
Publications
Vogt NM, Kerby RL, Dill-McFarland KA, Harding SJ, Merluzzi AP, Johnson SC, Carlsson CM, Asthana S, Zetterberg H, Blennow K, Bendlin BB, Rey FE. Gut microbiome alterations in Alzheimer's disease. Sci Rep. 2017 Oct 19;7(1):13537. doi: 10.1038/s41598-017-13601-y.
PubMed 29051531Mezo C, Dokalis N, Mossad O, Staszewski O, Neuber J, Yilmaz B, Schnepf D, de Aguero MG, Ganal-Vonarburg SC, Macpherson AJ, Meyer-Luehmann M, Staeheli P, Blank T, Prinz M, Erny D. Different effects of constitutive and induced microbiota modulation on microglia in a mouse model of Alzheimer's disease. Acta Neuropathol Commun. 2020 Jul 29;8(1):119. doi: 10.1186/s40478-020-00988-5.
PubMed 32727612Katsinelos T, Doulberis M, Polyzos SA, Papaefthymiou A, Katsinelos P, Kountouras J. Molecular Links Between Alzheimer's Disease and Gastrointestinal Microbiota: Emphasis on Helicobacter pylori Infection Involvement. Curr Mol Med. 2019;20(1):3-12. doi: 10.2174/1566524019666190917125917.
PubMed 31530263Roe K. An Alternative Explanation for Alzheimer's Disease and Parkinson's Disease Initiation from Specific Antibiotics, Gut Microbiota Dysbiosis and Neurotoxins. Neurochem Res. 2022 Mar;47(3):517-530. doi: 10.1007/s11064-021-03467-y. Epub 2021 Oct 20.
PubMed 34669122Wang M, Cao J, Gong C, Amakye WK, Yao M, Ren J. Exploring the microbiota-Alzheimer's disease linkage using short-term antibiotic treatment followed by fecal microbiota transplantation. Brain Behav Immun. 2021 Aug;96:227-238. doi: 10.1016/j.bbi.2021.06.003. Epub 2021 Jun 7.
PubMed 34111528Quigley EMM. Microbiota-Brain-Gut Axis and Neurodegenerative Diseases. Curr Neurol Neurosci Rep. 2017 Oct 17;17(12):94. doi: 10.1007/s11910-017-0802-6.
PubMed 29039142Martin CR, Osadchiy V, Kalani A, Mayer EA. The Brain-Gut-Microbiome Axis. Cell Mol Gastroenterol Hepatol. 2018 Apr 12;6(2):133-148. doi: 10.1016/j.jcmgh.2018.04.003. eCollection 2018.
PubMed 30023410Angelucci F, Cechova K, Amlerova J, Hort J. Antibiotics, gut microbiota, and Alzheimer's disease. J Neuroinflammation. 2019 May 22;16(1):108. doi: 10.1186/s12974-019-1494-4.
PubMed 31118068Doulberis M, Kotronis G, Gialamprinou D, Polyzos SA, Papaefthymiou A, Katsinelos P, Kountouras J. Alzheimer's disease and gastrointestinal microbiota; impact of Helicobacter pylori infection involvement. Int J Neurosci. 2021 Mar;131(3):289-301. doi: 10.1080/00207454.2020.1738432. Epub 2020 Mar 13.
PubMed 32125206Liu P, Wu L, Peng G, Han Y, Tang R, Ge J, Zhang L, Jia L, Yue S, Zhou K, Li L, Luo B, Wang B. Altered microbiomes distinguish Alzheimer's disease from amnestic mild cognitive impairment and health in a Chinese cohort. Brain Behav Immun. 2019 Aug;80:633-643. doi: 10.1016/j.bbi.2019.05.008. Epub 2019 May 4.
PubMed 31063846Zhuang ZQ, Shen LL, Li WW, Fu X, Zeng F, Gui L, Lu Y, Cai M, Zhu C, Tan YL, Zheng P, Li HY, Zhu J, Zhou HD, Bu XL, Wang YJ. Gut Microbiota is Altered in Patients with Alzheimer's Disease. J Alzheimers Dis. 2018;63(4):1337-1346. doi: 10.3233/JAD-180176.
PubMed 29758946Cattaneo A, Cattane N, Galluzzi S, Provasi S, Lopizzo N, Festari C, Ferrari C, Guerra UP, Paghera B, Muscio C, Bianchetti A, Volta GD, Turla M, Cotelli MS, Gennuso M, Prelle A, Zanetti O, Lussignoli G, Mirabile D, Bellandi D, Gentile S, Belotti G, Villani D, Harach T, Bolmont T, Padovani A, Boccardi M, Frisoni GB; INDIA-FBP Group. Association of brain amyloidosis with pro-inflammatory gut bacterial taxa and peripheral inflammation markers in cognitively impaired elderly. Neurobiol Aging. 2017 Jan;49:60-68. doi: 10.1016/j.neurobiolaging.2016.08.019. Epub 2016 Aug 31.
PubMed 27776263Liu M, Song S, Chen Q, Sun J, Chu W, Zhang Y, Ji F. Gut microbiota mediates cognitive impairment in young mice after multiple neonatal exposures to sevoflurane. Aging (Albany NY). 2021 Jun 28;13(12):16733-16748. doi: 10.18632/aging.203193. Epub 2021 Jun 28.
PubMed 34182544