Brain Health & the Microbiome

NCT06039267 | Completed

• 1 other identifier: NCR234792
• Study Type: observational
• Target: 44
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Mild Cognitive Impairment; Mild Dementia; Alzheimer Disease 1

Outcome Measures

Primary Outcomes (3)

• 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).

  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).

  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.

  3- and 6-months

Other Outcomes (7)

• Gut Microbiome Diversity (Index)

  6 months

• Gut Microbiome Composition (Shotgun Metagenomics)

  6 months

• Gut Microbiome Function (Shotgun Metagenomics)

  6 months

Study Arms (3)

Healthy Controls

Healthy males and females, ages 50-90

Other: Gut Microbiome Testing

Mild Cognitive Impairment

Males and females with mild cognitive impairment, ages 50-90

Other: Gut Microbiome Testing

Early Alzheimer's Disease

Males and females with early Alzheimer's disease, ages 50-90

Other: Gut Microbiome Testing

Interventions

Gut Microbiome Testing OTHER

Stool microbiome testing using shotgun metagenomic sequencing

Early Alzheimer's Disease; Healthy Controls; Mild Cognitive Impairment

Eligibility Criteria

• Age: 50 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Residents of the greater Washington, DC Metro Area.

You may qualify if:

• Age 50-90
• Early Alzheimer's Disease (eAD)
• Mild Cognitive Impairment (MCI)
• Healthy Control (no eAD or MCI)

You may not qualify if:

• Criteria or pathology that may affect the outcomes of the study or the risk/benefit ratio as determined by the study team

Sponsors & Collaborators

• George Washington University: lead

Study Sites (1)

George Washington University School of Medicine & Health Sciences

Washington D.C., District of Columbia, 20037, United States

Location

Related Publications (13)

• 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.

  PMID: 29051531 BACKGROUND

• Mezo 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.

  PMID: 32727612 BACKGROUND

• Katsinelos 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.

  PMID: 31530263 BACKGROUND

• Roe 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.

  PMID: 34669122 BACKGROUND

• Wang 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.

  PMID: 34111528 BACKGROUND

• Quigley 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.

  PMID: 29039142 BACKGROUND

• Martin 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.

  PMID: 30023410 BACKGROUND

• Angelucci 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.

  PMID: 31118068 BACKGROUND

• Doulberis 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.

  PMID: 32125206 BACKGROUND

• Liu 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.

  PMID: 31063846 BACKGROUND

• Zhuang 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.

  PMID: 29758946 BACKGROUND

• Cattaneo 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.

  PMID: 27776263 BACKGROUND

• Liu 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.

  PMID: 34182544 BACKGROUND

Related Links

• Lab Website

MeSH Terms

Conditions

Cognitive Dysfunction; Alzheimer disease type 1

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2023
• First Posted: September 15, 2023
• Study Start: August 25, 2023
• Primary Completion: August 24, 2025
• Study Completion: August 24, 2025
• Last Updated: January 29, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)