NCT05601856|Unknown
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Sponsor study identifier
observational
104
1 country
1
Study Start
December 15, 2022
Actual (reported)Primary Completion
April 30, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
July 30, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 30, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 27, 2022
Actual (reported)November 1, 2022
Actual (reported)December 15, 2022
Actual (reported)April 30, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
July 30, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Inflammation related biomarkers
interleukin (IL)-1β, IL-6, IL-10, IL-17, complement 3 (C3,) and YKL-40
one day
amyloid biomarker
amyloid beta (Aβ)1-42
one day
ratio of Aβ1-42 and Aβ1-40
one day
total tau biomarker
one day
phospho-tau at 181 or 217 biomarker
one day
neurodegeneration related biomarkers
neurofilament light chain (NFL) and neurogranin
one day
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" 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
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
Adults who are at risk for Alzheimer's Disease.
University of Virginia
Charlottesville, Virginia, 22908-0710, United States
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.
Vassar 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.
Selkoe DJ. Alzheimer's disease: genes, proteins, and therapy. Physiol Rev. 2001 Apr;81(2):741-66. doi: 10.1152/physrev.2001.81.2.741.
Blood Serum, 5 mL Stool Samples
First Submitted
October 27, 2022
First Posted
November 1, 2022
Study Start
December 15, 2022
Actual (reported)Primary Completion
April 30, 2025
Estimated (date passed)Glutathione, Brain Metabolism and Inflammation in Alzheimer's Disease
serum short chain fatty acids
acetic acid, propionic acid, isobutyric acid, butyric acid, valeric acid and hexanic acid
one day
Contact the study team to confirm eligibility.
Wang 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.
Saji 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.
Guo 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.
Wang 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.
Kim 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.
Li 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.
Lai 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.
Liu 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.
Colombo 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.
Marizzoni 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.
Norton 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.
Vitaliano 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.
Drouet B, Pincon-Raymond M, Chambaz J, Pillot T. Molecular basis of Alzheimer's disease. Cell Mol Life Sci. 2000 May;57(5):705-15. doi: 10.1007/s000180050035.
Gotz J, Streffer JR, David D, Schild A, Hoerndli F, Pennanen L, Kurosinski P, Chen F. Transgenic animal models of Alzheimer's disease and related disorders: histopathology, behavior and therapy. Mol Psychiatry. 2004 Jul;9(7):664-83. doi: 10.1038/sj.mp.4001508.
Heppner FL, Ransohoff RM, Becher B. Immune attack: the role of inflammation in Alzheimer disease. Nat Rev Neurosci. 2015 Jun;16(6):358-72. doi: 10.1038/nrn3880.
Dassel KB, Carr DC, Vitaliano P. Does Caring for a Spouse With Dementia Accelerate Cognitive Decline? Findings From the Health and Retirement Study. Gerontologist. 2017 Apr 1;57(2):319-328. doi: 10.1093/geront/gnv148.
Jack CR Jr, Bennett DA, Blennow K, Carrillo MC, Feldman HH, Frisoni GB, Hampel H, Jagust WJ, Johnson KA, Knopman DS, Petersen RC, Scheltens P, Sperling RA, Dubois B. A/T/N: An unbiased descriptive classification scheme for Alzheimer disease biomarkers. Neurology. 2016 Aug 2;87(5):539-47. doi: 10.1212/WNL.0000000000002923. Epub 2016 Jul 1.
Jack CR Jr, Bennett DA, Blennow K, Carrillo MC, Dunn B, Haeberlein SB, Holtzman DM, Jagust W, Jessen F, Karlawish J, Liu E, Molinuevo JL, Montine T, Phelps C, Rankin KP, Rowe CC, Scheltens P, Siemers E, Snyder HM, Sperling R; Contributors. NIA-AA Research Framework: Toward a biological definition of Alzheimer's disease. Alzheimers Dement. 2018 Apr;14(4):535-562. doi: 10.1016/j.jalz.2018.02.018.
Blennow K, Zetterberg H. Biomarkers for Alzheimer's disease: current status and prospects for the future. J Intern Med. 2018 Dec;284(6):643-663. doi: 10.1111/joim.12816. Epub 2018 Aug 19.
Hellwig K, Kvartsberg H, Portelius E, Andreasson U, Oberstein TJ, Lewczuk P, Blennow K, Kornhuber J, Maler JM, Zetterberg H, Spitzer P. Neurogranin and YKL-40: independent markers of synaptic degeneration and neuroinflammation in Alzheimer's disease. Alzheimers Res Ther. 2015 Dec 24;7:74. doi: 10.1186/s13195-015-0161-y.
Sharma N, Singh AN. Exploring Biomarkers for Alzheimer's Disease. J Clin Diagn Res. 2016 Jul;10(7):KE01-6. doi: 10.7860/JCDR/2016/18828.8166. Epub 2016 Jul 1.
Minter MR, Zhang C, Leone V, Ringus DL, Zhang X, Oyler-Castrillo P, Musch MW, Liao F, Ward JF, Holtzman DM, Chang EB, Tanzi RE, Sisodia SS. Antibiotic-induced perturbations in gut microbial diversity influences neuro-inflammation and amyloidosis in a murine model of Alzheimer's disease. Sci Rep. 2016 Jul 21;6:30028. doi: 10.1038/srep30028.
Bonfili L, Cecarini V, Berardi S, Scarpona S, Suchodolski JS, Nasuti C, Fiorini D, Boarelli MC, Rossi G, Eleuteri AM. Microbiota modulation counteracts Alzheimer's disease progression influencing neuronal proteolysis and gut hormones plasma levels. Sci Rep. 2017 May 25;7(1):2426. doi: 10.1038/s41598-017-02587-2.
Harach T, Marungruang N, Duthilleul N, Cheatham V, Mc Coy KD, Frisoni G, Neher JJ, Fak F, Jucker M, Lasser T, Bolmont T. Reduction of Abeta amyloid pathology in APPPS1 transgenic mice in the absence of gut microbiota. Sci Rep. 2017 Feb 8;7:41802. doi: 10.1038/srep41802.
Biagi E, Nylund L, Candela M, Ostan R, Bucci L, Pini E, Nikkila J, Monti D, Satokari R, Franceschi C, Brigidi P, De Vos W. Through ageing, and beyond: gut microbiota and inflammatory status in seniors and centenarians. PLoS One. 2010 May 17;5(5):e10667. doi: 10.1371/journal.pone.0010667.
Chen H, Meng L, Shen L. Multiple roles of short-chain fatty acids in Alzheimer disease. Nutrition. 2022 Jan;93:111499. doi: 10.1016/j.nut.2021.111499. Epub 2021 Sep 23.
Liu J, Li H, Gong T, Chen W, Mao S, Kong Y, Yu J, Sun J. Anti-neuroinflammatory Effect of Short-Chain Fatty Acid Acetate against Alzheimer's Disease via Upregulating GPR41 and Inhibiting ERK/JNK/NF-kappaB. J Agric Food Chem. 2020 Jul 8;68(27):7152-7161. doi: 10.1021/acs.jafc.0c02807. Epub 2020 Jun 25.
Killingsworth J, Sawmiller D, Shytle RD. Propionate and Alzheimer's Disease. Front Aging Neurosci. 2021 Jan 11;12:580001. doi: 10.3389/fnagi.2020.580001. eCollection 2020.
McKhann GM, Knopman DS, Chertkow H, Hyman BT, Jack CR Jr, Kawas CH, Klunk WE, Koroshetz WJ, Manly JJ, Mayeux R, Mohs RC, Morris JC, Rossor MN, Scheltens P, Carrillo MC, Thies B, Weintraub S, Phelps CH. The diagnosis of dementia due to Alzheimer's disease: recommendations from the National Institute on Aging-Alzheimer's Association workgroups on diagnostic guidelines for Alzheimer's disease. Alzheimers Dement. 2011 May;7(3):263-9. doi: 10.1016/j.jalz.2011.03.005. Epub 2011 Apr 21.
Sherwin E, Dinan TG, Cryan JF. Recent developments in understanding the role of the gut microbiota in brain health and disease. Ann N Y Acad Sci. 2018 May;1420(1):5-25. doi: 10.1111/nyas.13416. Epub 2017 Aug 2.
Olsson B, Lautner R, Andreasson U, Ohrfelt A, Portelius E, Bjerke M, Holtta M, Rosen C, Olsson C, Strobel G, Wu E, Dakin K, Petzold M, Blennow K, Zetterberg H. CSF and blood biomarkers for the diagnosis of Alzheimer's disease: a systematic review and meta-analysis. Lancet Neurol. 2016 Jun;15(7):673-684. doi: 10.1016/S1474-4422(16)00070-3. Epub 2016 Apr 8.
Cao L, Li L, Lin D, Zuo Z. Isoflurane induces learning impairment that is mediated by interleukin 1beta in rodents. PLoS One. 2012;7(12):e51431. doi: 10.1371/journal.pone.0051431. Epub 2012 Dec 12.
Wang Z, Meng S, Cao L, Chen Y, Zuo Z, Peng S. Critical role of NLRP3-caspase-1 pathway in age-dependent isoflurane-induced microglial inflammatory response and cognitive impairment. J Neuroinflammation. 2018 Apr 17;15(1):109. doi: 10.1186/s12974-018-1137-1.
Zhang J, Tan H, Jiang W, Zuo Z. Amantadine alleviates postoperative cognitive dysfunction possibly by increasing glial cell line-derived neurotrophic factor in rats. Anesthesiology. 2014 Oct;121(4):773-85. doi: 10.1097/ALN.0000000000000352.
Li H, Yin J, Li L, Deng J, Feng C, Zuo Z. Isoflurane postconditioning reduces ischemia-induced nuclear factor-kappaB activation and interleukin 1beta production to provide neuroprotection in rats and mice. Neurobiol Dis. 2013 Jun;54:216-24. doi: 10.1016/j.nbd.2012.12.014. Epub 2013 Jan 8.
Li J, Sheng W, Feng C, Zuo Z. Pyrrolidine dithiocarbamate attenuates brain Abeta increase and improves long-term neurological outcome in rats after transient focal brain ischemia. Neurobiol Dis. 2012 Jan;45(1):564-72. doi: 10.1016/j.nbd.2011.09.013. Epub 2011 Sep 24.
Watt G, Shang K, Zieba J, Olaya J, Li H, Garner B, Karl T. Chronic Treatment with 50 mg/kg Cannabidiol Improves Cognition and Moderately Reduces Abeta40 Levels in 12-Month-Old Male AbetaPPswe/PS1DeltaE9 Transgenic Mice. J Alzheimers Dis. 2020;74(3):937-950. doi: 10.3233/JAD-191242.
Randolph C, Tierney MC, Mohr E, Chase TN. The Repeatable Battery for the Assessment of Neuropsychological Status (RBANS): preliminary clinical validity. J Clin Exp Neuropsychol. 1998 Jun;20(3):310-9. doi: 10.1076/jcen.20.3.310.823.
Li Y, Chen D, Wang H, Wang Z, Song F, Li H, Ling L, Shen Z, Hu C, Peng J, Li W, Xing W, Pan J, Liang H, Zhou Q, Cai J, He Z, Peng S, Zeng W, Zuo Z. Intravenous versus Volatile Anesthetic Effects on Postoperative Cognition in Elderly Patients Undergoing Laparoscopic Abdominal Surgery. Anesthesiology. 2021 Mar 1;134(3):381-394. doi: 10.1097/ALN.0000000000003680.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
July 30, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
March 27, 2025
Record last verified: 2024-05
If shared, it will be de-identified data.
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