Book contents
- Alzheimer’s Disease Drug Development
- Alzheimer’s Disease Drug Development
- Copyright page
- Dedication
- Contents
- Contributors
- Foreword
- Acknowledgments
- Section 1 Advancing Alzheimer’s Disease Therapies in a Collaborative Science Ecosystem
- Section 2 Non-clinical Assessment of Alzheimer’s Disease Candidate Drugs
- Section 3 Alzheimer’s Disease Clinical Trials
- 11 Phase 1 Trials in Alzheimer’s Disease Drug Development
- 12 The Importance of Phase 2 in Drug Development for Alzheimer’s Disease
- 13 Alzheimer’s Disease Drug Development in Pharmaceutical Companies
- 14 Trial Site Infrastructure and Management: Importance to Alzheimer’s Disease Drug Development
- 15 ATRI and ACTC: Academic Programs to Accelerate Alzheimer’s Disease Drug Development
- 16 The European Prevention of Alzheimer’s Disease Program: A Public–Private Partnership to Facilitate the Secondary Prevention of Alzheimer’s Disease Dementia
- 17 The Global Alzheimer’s Platform Foundation®: Delivering New Medicines Faster by Accelerating Clinical Trials
- 18 Clinical Trial Development in Frontotemporal Lobar Degeneration
- 19 Statistical Considerations in the Design and Analysis of Alzheimer’s Disease Clinical Trials
- 20 Alzheimer’s Disease Trial Recruitment and Diversifying Trial Populations
- 21 The Role of Online Registries in Accelerating Alzheimer’s Disease Drug Development
- 22 Data Safety Monitoring Boards in Alzheimer’s Disease Trials
- 23 Globalization of Alzheimer’s Disease Clinical Trials
- 24 The Use and Development of Clinical Measures of Alzheimer’s Disease Trials
- 25 Tele-Trials, Remote Monitoring, and Trial Technology for Alzheimer’s Disease Clinical Trials
- 26 Expanded Access and Compassionate Use in Alzheimer’s Disease Drug Development
- 27 The Role of the Contract Research Organization in Alzheimer’s Disease: The Vital Link in the Clinical Drug-Development Program
- 28 The Role of Regulatory Agencies in Alzheimer’s Disease Drug Development
- 29 Alzheimer’s Disease Clinical Trial Study Partners
- 30 From Trials to Practice: Are We Ready for a Disease-Modifying Treatment?
- 31 Best Practices for Clinical Trials during COVID-19
- Section 4 Imaging and Biomarker Development in Alzheimer’s Disease Drug Discovery
- Section 5 Academic Drug-Development Programs
- Section 6 Public–Private Partnerships in Alzheimer’s Disease Drug Development
- Section 7 Funding and Financing Alzheimer’s Disease Drug Development
- Index
- References
23 - Globalization of Alzheimer’s Disease Clinical Trials
from Section 3 - Alzheimer’s Disease Clinical Trials
Published online by Cambridge University Press: 03 March 2022
Book contents
- Alzheimer’s Disease Drug Development
- Alzheimer’s Disease Drug Development
- Copyright page
- Dedication
- Contents
- Contributors
- Foreword
- Acknowledgments
- Section 1 Advancing Alzheimer’s Disease Therapies in a Collaborative Science Ecosystem
- Section 2 Non-clinical Assessment of Alzheimer’s Disease Candidate Drugs
- Section 3 Alzheimer’s Disease Clinical Trials
- 11 Phase 1 Trials in Alzheimer’s Disease Drug Development
- 12 The Importance of Phase 2 in Drug Development for Alzheimer’s Disease
- 13 Alzheimer’s Disease Drug Development in Pharmaceutical Companies
- 14 Trial Site Infrastructure and Management: Importance to Alzheimer’s Disease Drug Development
- 15 ATRI and ACTC: Academic Programs to Accelerate Alzheimer’s Disease Drug Development
- 16 The European Prevention of Alzheimer’s Disease Program: A Public–Private Partnership to Facilitate the Secondary Prevention of Alzheimer’s Disease Dementia
- 17 The Global Alzheimer’s Platform Foundation®: Delivering New Medicines Faster by Accelerating Clinical Trials
- 18 Clinical Trial Development in Frontotemporal Lobar Degeneration
- 19 Statistical Considerations in the Design and Analysis of Alzheimer’s Disease Clinical Trials
- 20 Alzheimer’s Disease Trial Recruitment and Diversifying Trial Populations
- 21 The Role of Online Registries in Accelerating Alzheimer’s Disease Drug Development
- 22 Data Safety Monitoring Boards in Alzheimer’s Disease Trials
- 23 Globalization of Alzheimer’s Disease Clinical Trials
- 24 The Use and Development of Clinical Measures of Alzheimer’s Disease Trials
- 25 Tele-Trials, Remote Monitoring, and Trial Technology for Alzheimer’s Disease Clinical Trials
- 26 Expanded Access and Compassionate Use in Alzheimer’s Disease Drug Development
- 27 The Role of the Contract Research Organization in Alzheimer’s Disease: The Vital Link in the Clinical Drug-Development Program
- 28 The Role of Regulatory Agencies in Alzheimer’s Disease Drug Development
- 29 Alzheimer’s Disease Clinical Trial Study Partners
- 30 From Trials to Practice: Are We Ready for a Disease-Modifying Treatment?
- 31 Best Practices for Clinical Trials during COVID-19
- Section 4 Imaging and Biomarker Development in Alzheimer’s Disease Drug Discovery
- Section 5 Academic Drug-Development Programs
- Section 6 Public–Private Partnerships in Alzheimer’s Disease Drug Development
- Section 7 Funding and Financing Alzheimer’s Disease Drug Development
- Index
- References
Summary
Globalization in clinical trials for Alzheimer’s disease (AD) drug development has increased rapidly. It would substantially support persons with dementia to access novel therapeutics in a coordinated and efficient manner. In this chapter, we overview the significant drives of globalization in AD drug development: the growth of the world’s AD population, the need for a larger sample in trials to secure enrollment in the required timeframe, and the ethnographic and ethnobiological contributors. We also discuss the major issues relevant to global trials: the geographic variation across trial sites, the differences in study participants, and the lack of harmonized global regulatory mechanisms. In the end, this chapter recommends that improving site performance, enhancing infrastructure development, and promoting universal regulatory mechanism should be prioritized to maximize the contribution of globalization to the AD drug development ecosystem.
- Type
- Chapter
- Information
- Alzheimer's Disease Drug DevelopmentResearch and Development Ecosystem, pp. 275 - 280Publisher: Cambridge University PressPrint publication year: 2022
References
Wimo, A. The worldwide costs of dementia 2015 and comparisons with 2010. Alzheimers Dement 2017; 13: 1–7.CrossRefGoogle ScholarPubMed
Gustavsson, A, Green, C, Jones, RW, et al. Current issues and future research priorities for health economic modelling across the full continuum of Alzheimer’s disease. Alzheimers Dement 2017; 13: 312–21.Google Scholar
Prince, M, Ali, G, Guerchet, M, et al. Recent global trends in the prevalence and incidence of dementia, and survival with dementia. Alzheimers Res Ther 2016; 8: 23.CrossRefGoogle ScholarPubMed
Thiers, FA, Sinskey, AJ, Berndt, ER. Trends in the globalization of clinical trials. Nat Rev Drug Discov 2008; 7: 13–14.CrossRefGoogle Scholar
Cummings, J, Lee, G, Ritter, A, Sabbagh, M, Zhong, K. Alzheimer’s disease drug-development pipeline: 2020. Alzheimers Dement (N Y) 2020; 6: e12050.CrossRefGoogle ScholarPubMed
Nichols, E, Szoeke, CEI, Vollset, SE, et al. Global, regional, and national burden of Alzheimer’s disease and other dementias, 1990–2016: a systematic analysis for the Global Burden of Disease Study 2016. Lancet Neurol 2019; 18: 88–106.Google Scholar
Qiao, Y, Alexander, GC, Moore, TJ. Globalization of clinical trials: variation in estimated regional costs of pivotal trials, 2015–2016. Clin Trials 2019; 16: 329–33.CrossRefGoogle ScholarPubMed
Alzheimer’s Disease International. Dementia statistics. Available at: www.alzint.org/about/dementia-facts-figures/dementia-statistics/ (accessed June 29, 2021).Google Scholar
Jia, L, Du, Y, Chu, L, et al. Prevalence, risk factors, and management of dementia and mild cognitive impairment in adults aged 60 years or older in China: a cross-sectional study. Lancet Public Health 2020; 5: e661–71.Google Scholar
Jia, L, Quan, M, Fu, Y, et al. Dementia in China: epidemiology, clinical management, and research advances. Lancet Neurol 2019; 4422: 1–12.Google Scholar
Jones, CW, Handler, L, Crowell, KE, et al. Non-publication of large randomized clinical trials: cross sectional analysis. BMJ 2013; 347: 1–9.Google Scholar
Gauthier, S, Albert, M, Fox, N, et al. Why has therapy development for dementia failed in the last two decades? Alzheimers Dement 2016; 12: 60–4.CrossRefGoogle ScholarPubMed
Goldman, DP, Fillit, H, Neumann, P. Accelerating Alzheimer’s disease drug innovations from the research pipeline to patients. Alzheimers Dement 2018; 14: 833–6.Google Scholar
Jia, J, Zuo, X, Jia, XF, et al. Diagnosis and treatment of dementia in neurology outpatient departments of general hospitals in China. Alzheimers Dement 2016; 12: 446–53.CrossRefGoogle ScholarPubMed
Wang, H, Xie, H, Qu, Q, et al. The continuum of care for dementia: needs, resources and practice in China. J Glob Health 2019; 9: 020321.CrossRefGoogle ScholarPubMed
Long, JM, Holtzman, DM. Alzheimer disease: an update on pathobiology and treatment strategies. Cell 2019; 179: 312–39.Google Scholar
Wang, X, Wang, H, Li, H, Li, T, Yu, X. Frequency of the apolipoprotein E ε4 allele in a memory clinic cohort in Beijing: a naturalistic descriptive study. PLoS One 2014; 9: e99130.CrossRefGoogle Scholar
Zhang, M, Wang, H, Li, T, Yu, X. Prevalence of neuropsychiatric symptoms across the declining memory continuum: an observational study in a memory clinic setting. Dement Geriatr Cogn Dis Extra 2012; 2: 200–8.CrossRefGoogle Scholar
Petersen, RC, Thomas, RG, Aisen, PS, et al. Randomized controlled trials in mild cognitive impairment: sources of variability. Neurology 2017; 88: 1751–8.CrossRefGoogle ScholarPubMed
Zhao, M, Lv, X, Tuerxun, M, et al. Delayed help seeking behavior in dementia care: preliminary findings from the Clinical Pathway for Alzheimer’s Disease in China (CPAD) study. Int Psychogeriatr 2016; 28: 211–19.Google Scholar
Paulino Ramirez, Diaz S, Gil Gregório, P, Manuel Ribera Casado, J, et al. The need for a consensus in the use of assessment tools for Alzheimer’s disease: the Feasibility Study (assessment tools for dementia in Alzheimer centres across Europe), a European Alzheimer’s Disease Consortium’s (EADC) survey. Int J Geriatr Psychiatry 2005; 20: 744–8.Google Scholar
Shen, JHQ, Shen, Q, Yu, H, et al. Validation of an Alzheimer’s disease assessment battery in Asian participants with mild to moderate Alzheimer’s disease. Am J Neurodegener Dis 2014; 3: 158–69.Google Scholar
Pocock, S, Calvo, G, Marrugat, J, et al. International differences in treatment effect: do they really exist and why? Eur Heart J 2013; 34: 1846–52.Google Scholar
Mentz, RJ, Kaski, J-C, Dan, G-A, et al. Implications of geographical variation on clinical outcomes of cardiovascular trials. Am Heart J 2012; 164: 303–12.Google Scholar
Kristensen, SL, Martinez, F, Jhund, PS, et al. Geographic variations in the PARADIGM-HF heart failure trial. Eur Heart J 2016; 37: 3167–74.Google Scholar
Cummings, JL, Atri, A, Ballard, C, et al. Insights into globalization: comparison of patient characteristics and disease progression among geographic regions in a multinational Alzheimer’s disease clinical program. Alzheimers Res Ther 2018; 10: 116.CrossRefGoogle Scholar
Cummings, J, Reynders, R, Zhong, K. Globalization of Alzheimer’s disease clinical trials. Alzheimers Res Ther 2011; 3: 24.Google Scholar
Wang, H. Nexus between cognitive reserve and modifiable risk factors of dementia. Int Psychogeriatr 2020; 32: 559–62.CrossRefGoogle Scholar
Wang, J, Gu, Y, Dong, W, et al. Lower small-worldness of intrinsic brain networks facilitates the cognitive protection of intellectual engagement in elderly people without dementia: a near-infrared spectroscopy study. Am J Geriatr Psychiatry 2020; 28: 722–31.CrossRefGoogle ScholarPubMed
Henley, DB, Dowsett, SA, Chen, YF, et al. Alzheimer’s disease progression by geographical region in a clinical trial setting. Alzheimers Res Ther 2015; 7: 43.CrossRefGoogle Scholar
Jack, CR, Bennett, DA, Blennow, K, et al. NIA–AA Research Framework: toward a biological definition of Alzheimer’s disease. Alzheimers Dement 2018; 14: 535–62.CrossRefGoogle Scholar
Hampel, H, Vergallo, A, Flores Aguilar, L, et al. Precision pharmacology for Alzheimer’s disease for the Alzheimer Precision Medicine Initiative (APMI). Pharmacol Res 2018; 130: 331–65.CrossRefGoogle Scholar
Wang, X, Sun, G, Feng, T, et al. Sodium oligomannate therapeutically remodels gut microbiota and suppresses gut bacterial amino acids shaped neuroinflammation to inhibit Alzheimer’s disease progression. Cell Res 2019; 29: 787–803.CrossRefGoogle ScholarPubMed
Xiao, S, Chan, P, Wang, T, et al. A 36-week multicenter, randomized, double-blind, placebo-controlled, parallel-group, Phase 3 clinical trial of sodium oligomannate for mild-to-moderate Alzheimer’s dementia. Alzheimers Res Ther 2021; 13: 62.Google Scholar
Editorial. Alzheimer’s disease research enterprise in the era of COVID-19/SARS-CoV-2. Alzheimers Dement 2020; 16: 587–8.Google Scholar