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
18 - Clinical Trial Development in Frontotemporal Lobar Degeneration
from Section 3 - Alzheimer’s Disease Clinical Trials
Published online by Cambridge University Press: 03 March 2022
- 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
Frontotemporal lobar degeneration (FTLD), a major cause of dementia worldwide, is an unrelenting and ultimately fatal set of pathological processes without any approved disease-modifying therapies. Clinical trial development in FTLD has previously been challenging, due to its pathological heterogeneity aand the clinical heterogeneity of frontotemporal dementia (FTD) and other clinical syndromes that arise from FTLD. Advances in FTLD basic science research have recently translated into a growing field of FTLD clinical trial development, with a particular focus on therapies tailored to distinct clinical syndromes with the highest specificity for particular FTLD pathophysiologies. The expansion of FTLD clinical programs has been fostered by a variety of advocacy groups and a number of large multi-site clinical research consortia, the latter of which have advanced the investigation of fluid biomarkers and clinical and neuroimaging measures for use in future clinical trials. This chapter covers the unique considerations of clinical trials in patients with FTLD pathology and review previous and current clinical trial programs investigating disease-modifying therapies targeting FTLD.
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- Alzheimer's Disease Drug DevelopmentResearch and Development Ecosystem, pp. 216 - 231Publisher: Cambridge University PressPrint publication year: 2022