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
- 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
- 40 Alzheimer’s Disease Neuroimaging Initiative
- Section 7 Funding and Financing Alzheimer’s Disease Drug Development
- Index
- References
40 - Alzheimer’s Disease Neuroimaging Initiative
from Section 6 - Public–Private Partnerships in Alzheimer’s Disease Drug Development
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
- 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
- 40 Alzheimer’s Disease Neuroimaging Initiative
- Section 7 Funding and Financing Alzheimer’s Disease Drug Development
- Index
- References
Summary
The Alzheimer’s Disease Neuroimaging Initiative (ADNI) is a longitudinal, observational study initiated in 2004 with the aim to develop and validate biomarkers for Alzheimer’s disease (AD) trials. From its inception, ADNI has been a model of a public–private partnership, with industry partners involved not only through financial support but in a guidance capacity. Through the development of standardized methods, ADNI has collected imaging and fluid biomarker data from cognitively normal, early and late mild cognitive impairment, and AD participants which is available to qualified researchers without embargo. Moreover, these methods have been incorporated into companion studies worldwide. The data that have been collected have provided important insights into the progression of AD pathology over time, assists in understanding which biomarkers may be most useful in clinical trials and have facilitated the design of studies of disease-modifying therapies.
Keywords
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- Chapter
- Information
- Alzheimer's Disease Drug DevelopmentResearch and Development Ecosystem, pp. 455 - 464Publisher: Cambridge University PressPrint publication year: 2022
References
Schneider, LS, Mangialasche, F, Andreasen, N, et al. Clinical trials and late-stage drug development for Alzheimer’s disease: an appraisal from 1984 to 2014. J Intern Med 2014; 275: 251–83.Google Scholar
Petersen, RC, Doody, R, Kurz, A, et al. Current concepts in mild cognitive impairment. Arch Neurol 2001; 58: 1985–92.Google Scholar
Becker, RE, Greig, NH. Alzheimer’s disease drug development in 2008 and beyond: problems and opportunities. Curr Alzheimer Res 2008; 5: 346–57.Google Scholar
Cummings, JL. Integrating ADNI results into Alzheimer’s disease drug development programs. Neurobiol Aging 2010; 31: 1481–92.CrossRefGoogle ScholarPubMed
Mueller, SG, Weiner, MW, Thal, LJ, et al. The Alzheimer’s Disease Neuroimaging Initiative. Neuroimaging Clin N Am 2005; 15: 869-xii.Google Scholar
Weiner, MW, Aisen, PS, Jack, CR, et al. The Alzheimer’s Disease Neuroimaging Initiative: progress report and future plans. Alzheimers Dement 2010; 6: 202–11.e7.Google Scholar
Weiner, MW, Veitch, DP, Aisen, PS, et al. 2014 Update of the Alzheimer’s Disease Neuroimaging Initiative: a review of papers published since its inception. Alzheimers Dement 2015; 11: e1–120.Google Scholar
Weiner, MW, Veitch, DP, Aisen, PS, et al. The Alzheimer’s Disease Neuroimaging Initiative 3: continued innovation for clinical trial improvement. Alzheimers Dement 2017; 13: 561–71.Google Scholar
Lee, S, Bozeman, B. The impact of research collaboration on scientific productivity. Soc Stud Sci 2005; 35: 673–702.Google Scholar
Jones-Davis, DM, Buckholtz, N. The impact of ADNI: what role do public–private partnerships have in pushing the boundaries of clinical and basic science research on Alzheimer’ s disease. Alzheimers Dement 2015; 11: 860–4.CrossRefGoogle ScholarPubMed
Aisen, PS, Petersen, RC, Donohue, MC, et al. Clinical Core of the Alzheimer’s Disease Neuroimaging Initiative: progress and plans. Alzheimers Dement 2010; 6: 239–46.Google Scholar
Jack, CR, Bernstein, MA, Borowski, BJ, et al. Update on the MRI core of the Alzheimer’s Disease Neuroimaging Initiative. Alzheimers Dement 2010; 6: 212–20.Google Scholar
Kang, J, Korecka, M, Figurski, MJ, et al. The Alzheimer’s Disease Neuroimaging Initiative 2 Biomarker Core: a review of progress and plans. Alzheimers Dement 2015; 11: 772–91.Google Scholar
Saykin, AJ, Shen, L, Yao, X, et al. Genetic studies of quantitative MCI and AD phenotypes in ADNI: progress, opportunities, and plans. Alzheimers Dement 2015; 11: 792–814.Google Scholar
Toga, AW, Crawford, KL. The Alzheimer’s Disease Neuroimaging Initiative Informatics Core: a decade in review. Alzheimers Dement 2015; 11: 832–9.Google Scholar
Carillo, MC, Bain, LJ, Frisoni, GB, Weiner, MW. Worldwide Alzheimer’s Disease Neuroimaging Initiative. Alzheimers Dement 2012; 8: 337–42.Google Scholar
Donohue, MC, Gamst, AC, Thomas, RG, et al. The relative efficiency of time-to-threshold and rate of change in longitudinal data. Contemp Clin Trials 2011; 32: 685–93.Google Scholar
Aisen, PS, Andrieu, S, Sampaio, C, et al. Report of the task force on designing clinical trials in early (predementia) AD. Neurology 2011; 76: 280–6.Google Scholar
Aisen, PS, Vellas, B, Hampel, H. Moving towards early clinical trials for amyloid-targeted therapy in Alzheimer’s disease. Nat Rev Drug Discov 2013; 12: 324.Google Scholar
Shaw, LM, Vanderstichele, H, Knapik-Czajka, M, et al. Cerebrospinal fluid biomarker signature in Alzheimer’s Disease Neuroimaging Initiative subjects. Ann Neurol 2009; 65: 403–13.Google Scholar
Jack, CR Jr., Lowe, VJ, Weigand, SD, et al. Serial PIB and MRI in normal, mild cognitive impairment and Alzheimer’s disease: implications for sequence of pathological events in Alzheimer’s disease. Brain 2009; 132: 1355–65.Google Scholar
Veitch, DP, Weiner, MW, Aisen, PS, et al. Understanding disease progression and improving Alzheimer’s disease clinical trials: recent highlights from the Alzheimer’s Disease Neuroimaging Initiative. Alzheimers Dement 2019; 15: 106–52.Google 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
Nelson, PT, Alafuzoff, I, Bigio, EH, et al. Correlation of Alzheimer disease neuropathologic changes with cognitive status: a review of the literature. J Neuropathol Exp Neurol 2012; 71: 362–8.CrossRefGoogle ScholarPubMed
Braak, H, Braak, E. Staging of Alzheimer’s disease-related neurofibrillary changes. Neurobiol Aging 1995; 16: 271–8.Google Scholar
Wang, J, Logovinsky, V, Hendrix, SB, et al. ADCOMS: a composite clinical outcome for prodromal Alzheimer’s disease trials. J Neurol Neurosurg Psychiatry 2016; 87: 993–9.Google Scholar
Wolz, R, Schwarz, AJ, Gray, KR, Yu, P, Hill, DL, Alzheimer’s Disease Neuroimaging Initiative. Enrichment of clinical trials in MCI due to AD using markers of amyloid and neurodegeneration. Neurology 2016; 87: 1235–41.Google Scholar
Jelic, V, Kivipelto, M, Winblad, B. Clinical trials in mild cognitive impairment: lessons for the future. J Neurol Neurosurg Psychiatry 2006; 77: 429–38.CrossRefGoogle ScholarPubMed
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