drugset / Trial / NCT04249869
The Efficacy of Traditional Chinese Herbal Medicine for Alzheimer's Disease
RandomizedCrossoverTriple-blindTreatment
Summary
This randomized, double-blinded, placebo-controlled, crossover clinical trial aims to investigate the effect of VGH-AD1, a scientific Chinese medicine powder prescription, on patients with Alzheimer's disease.
Timeline
- Start
- 2020-02-01
- Primary completion
- 2020-12-31
- Completion
- 2020-12-31
Publications
- Background 2011 Taiwan Longitudinal Study on Aging Survey Report Health Promotion Administration, Ministry of Health and Welfare 2014.
- Background Albert MS, Blacker D. Mild cognitive impairment and dementia. Annu Rev Clin Psychol. 2006;2:379-88. doi: 10.1146/annurev.clinpsy.1.102803.144039.
- Background Chen TB, Yiao SY, Sun Y, Lee HJ, Yang SC, Chiu MJ, Chen TF, Lin KN, Tang LY, Lin CC, Wang PN. Comorbidity and dementia: A nationwide survey in Taiwan. PLoS One. 2017 Apr 12;12(4):e0175475. doi: 10.1371/journal.pone.0175475. eCollection 2017.
- Background Shen CY, Jiang JG, Yang L, Wang DW, Zhu W. Anti-ageing active ingredients from herbs and nutraceuticals used in traditional Chinese medicine: pharmacological mechanisms and implications for drug discovery. Br J Pharmacol. 2017 Jun;174(11):1395-1425. doi: 10.1111/bph.13631. Epub 2016 Oct 29.
- Background Shanthi KB, Krishnan S, Rani P. A systematic review and meta-analysis of plasma amyloid 1-42 and tau as biomarkers for Alzheimer's disease. SAGE Open Med. 2015 Aug 10;3:2050312115598250. doi: 10.1177/2050312115598250. eCollection 2015.
- Background Shekhar S, Kumar R, Rai N, Kumar V, Singh K, Upadhyay AD, Tripathi M, Dwivedi S, Dey AB, Dey S. Estimation of Tau and Phosphorylated Tau181 in Serum of Alzheimer's Disease and Mild Cognitive Impairment Patients. PLoS One. 2016 Jul 26;11(7):e0159099. doi: 10.1371/journal.pone.0159099. eCollection 2016.
- Background Zhang A, Sun H, Wang P, Han Y, Wang X. Future perspectives of personalized medicine in traditional Chinese medicine: a systems biology approach. Complement Ther Med. 2012 Feb-Apr;20(1-2):93-9. doi: 10.1016/j.ctim.2011.10.007. Epub 2011 Nov 30.
- Background Li L, Zhang L, Yang CC. Multi-Target Strategy and Experimental Studies of Traditional Chinese Medicine for Alzheimer's Disease Therapy. Curr Top Med Chem. 2016;16(5):537-48. doi: 10.2174/1568026615666150813144003.
- Background Lin SK, Yan SH, Lai JN, Tsai TH. Patterns of Chinese medicine use in prescriptions for treating Alzheimer's disease in Taiwan. Chin Med. 2016 Mar 28;11:12. doi: 10.1186/s13020-016-0086-9. eCollection 2016.
- Background Chen KH, Yeh MH, Livneh H, Chen BC, Lin IH, Lu MC, Tsai TY, Yeh CC. Association of traditional Chinese medicine therapy and the risk of dementia in patients with hypertension: a nationwide population-based cohort study. BMC Complement Altern Med. 2017 Mar 29;17(1):178. doi: 10.1186/s12906-017-1677-4.
- Background Ho YS, So KF, Chang RC. Drug discovery from Chinese medicine against neurodegeneration in Alzheimer's and vascular dementia. Chin Med. 2011 Apr 22;6:15. doi: 10.1186/1749-8546-6-15.
- Background Chen D, Yang X, Yang J, Lai G, Yong T, Tang X, Shuai O, Zhou G, Xie Y, Wu Q. Prebiotic Effect of Fructooligosaccharides from Morinda officinalis on Alzheimer's Disease in Rodent Models by Targeting the Microbiota-Gut-Brain Axis. Front Aging Neurosci. 2017 Dec 8;9:403. doi: 10.3389/fnagi.2017.00403. eCollection 2017.
- Background Ma X, Tan C, Zhu D, Gang DR, Xiao P. Huperzine A from Huperzia species--an ethnopharmacolgical review. J Ethnopharmacol. 2007 Aug 15;113(1):15-34. doi: 10.1016/j.jep.2007.05.030. Epub 2007 Jun 2.
- Background Iwasaki K, Satoh-Nakagawa T, Maruyama M, Monma Y, Nemoto M, Tomita N, Tanji H, Fujiwara H, Seki T, Fujii M, Arai H, Sasaki H. A randomized, observer-blind, controlled trial of the traditional Chinese medicine Yi-Gan San for improvement of behavioral and psychological symptoms and activities of daily living in dementia patients. J Clin Psychiatry. 2005 Feb;66(2):248-52. doi: 10.4088/jcp.v66n0214.
- Background Mizukami K, Asada T, Kinoshita T, Tanaka K, Sonohara K, Nakai R, Yamaguchi K, Hanyu H, Kanaya K, Takao T, Okada M, Kudo S, Kotoku H, Iwakiri M, Kurita H, Miyamura T, Kawasaki Y, Omori K, Shiozaki K, Odawara T, Suzuki T, Yamada S, Nakamura Y, Toba K. A randomized cross-over study of a traditional Japanese medicine (kampo), yokukansan, in the treatment of the behavioural and psychological symptoms of dementia. Int J Neuropsychopharmacol. 2009 Mar;12(2):191-9. doi: 10.1017/S146114570800970X. Epub 2008 Dec 11.
- Background Kawakami Z, Kanno H, Ueki T, Terawaki K, Tabuchi M, Ikarashi Y, Kase Y. Neuroprotective effects of yokukansan, a traditional Japanese medicine, on glutamate-mediated excitotoxicity in cultured cells. Neuroscience. 2009 Apr 10;159(4):1397-407. doi: 10.1016/j.neuroscience.2009.02.004. Epub 2009 Feb 7.
- Background Egashira N, Iwasaki K, Ishibashi A, Hayakawa K, Okuno R, Abe M, Uchida N, Mishima K, Takasaki K, Nishimura R, Oishi R, Fujiwara M. Repeated administration of Yokukansan inhibits DOI-induced head-twitch response and decreases expression of 5-hydroxytryptamine (5-HT)2A receptors in the prefrontal cortex. Prog Neuropsychopharmacol Biol Psychiatry. 2008 Aug 1;32(6):1516-20. doi: 10.1016/j.pnpbp.2008.05.010. Epub 2008 May 20.
- Background Bounda GA, Feng YU. Review of clinical studies of Polygonum multiflorum Thunb. and its isolated bioactive compounds. Pharmacognosy Res. 2015 Jul-Sep;7(3):225-36. doi: 10.4103/0974-8490.157957.
- Background Buchter C, Zhao L, Havermann S, Honnen S, Fritz G, Proksch P, Watjen W. TSG (2,3,5,4'-Tetrahydroxystilbene-2-O- beta -D-glucoside) from the Chinese Herb Polygonum multiflorum Increases Life Span and Stress Resistance of Caenorhabditis elegans. Oxid Med Cell Longev. 2015;2015:124357. doi: 10.1155/2015/124357. Epub 2015 May 5.
- Background Park SY, Jin ML, Chae SY, Ko MJ, Choi YH, Park G, Choi YW. Novel compound from Polygonum multiflorum inhibits inflammatory response in LPS-stimulated microglia by upregulating AMPK/Nrf2 pathways. Neurochem Int. 2016 Nov;100:21-29. doi: 10.1016/j.neuint.2016.08.006. Epub 2016 Aug 19.
- Background Mazure CM, Swendsen J. Sex differences in Alzheimer's disease and other dementias. Lancet Neurol. 2016 Apr;15(5):451-2. doi: 10.1016/S1474-4422(16)00067-3. No abstract available.
- Background Au B, Dale-McGrath S, Tierney MC. Sex differences in the prevalence and incidence of mild cognitive impairment: A meta-analysis. Ageing Res Rev. 2017 May;35:176-199. doi: 10.1016/j.arr.2016.09.005. Epub 2016 Oct 19.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | VGH-AD1 | Traditional medicine (herbal / TCM) | 7.5 g | — |