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Literature DB >> 25669145

The future is now: model-based clinical trial design for Alzheimer's disease.

K Romero¹, K Ito, J A Rogers, D Polhamus, R Qiu, D Stephenson, R Mohs, R Lalonde, V Sinha, Y Wang, D Brown, M Isaac, S Vamvakas, R Hemmings, L Pani, L J Bain, B Corrigan.

Abstract

Failures in trials for Alzheimer's disease (AD) may be attributable to inadequate dosing, population selection, drug inefficacy, or insufficient design optimization. The Coalition Against Major Diseases (CAMD) was formed in 2008 to develop drug development tools (DDT) to expedite drug development for AD and Parkinson's disease. CAMD led a process that successfully advanced a clinical trial simulation (CTS) tool for AD through the formal regulatory review process at the US Food and Drug Administration (FDA) and European Medicines Agency (EMA).

Entities: Chemical Disease Gene Species

Mesh：

Year: 2014 PMID： 25669145 PMCID： PMC6463482 DOI： 10.1002/cpt.16

Source DB: PubMed Journal: Clin Pharmacol Ther ISSN： 0009-9236 Impact factor: 6.875

5 in total

1. An improved model for disease progression in patients from the Alzheimer's disease neuroimaging initiative.

Authors: Mahesh N Samtani; Michael Farnum; Victor Lobanov; Eric Yang; Nandini Raghavan; Allitia Dibernardo; Vaibhav Narayan
Journal: J Clin Pharmacol Date: 2011-06-09 Impact factor: 3.126

2. Combining patient-level and summary-level data for Alzheimer's disease modeling and simulation: a β regression meta-analysis.

Authors: James A Rogers; Daniel Polhamus; William R Gillespie; Kaori Ito; Klaus Romero; Ruolun Qiu; Diane Stephenson; Marc R Gastonguay; Brian Corrigan
Journal: J Pharmacokinet Pharmacodyn Date: 2012-07-21 Impact factor: 2.745

3. A double-blind, delayed-start trial of rasagiline in Parkinson's disease (the ADAGIO study): prespecified and post-hoc analyses of the need for additional therapies, changes in UPDRS scores, and non-motor outcomes.

Authors: Olivier Rascol; Cheryl J Fitzer-Attas; Robert Hauser; Joseph Jankovic; Anthony Lang; J William Langston; Eldad Melamed; Werner Poewe; Fabrizio Stocchi; Eduardo Tolosa; Eli Eyal; Yoni M Weiss; C Warren Olanow
Journal: Lancet Neurol Date: 2011-04-07 Impact factor: 44.182

4. The Coalition Against Major Diseases: developing tools for an integrated drug development process for Alzheimer's and Parkinson's diseases.

Authors: K Romero; M de Mars; D Frank; M Anthony; J Neville; L Kirby; K Smith; R L Woosley
Journal: Clin Pharmacol Ther Date: 2009-10 Impact factor: 6.875

5. Methodologic aspects of a population pharmacodynamic model for cognitive effects in Alzheimer patients treated with tacrine.

Authors: N H Holford; K E Peace
Journal: Proc Natl Acad Sci U S A Date: 1992-12-01 Impact factor: 11.205

5 in total

28 in total

1. Penalized nonlinear mixed effects model to identify biomarkers that predict disease progression.

Authors: Huaihou Chen; Donglin Zeng; Yuanjia Wang
Journal: Biometrics Date: 2017-02-09 Impact factor: 2.571

2. Towards regulatory endorsement of drug development tools to promote the application of model-informed drug development in Duchenne muscular dystrophy.

Authors: Daniela J Conrado; Jane Larkindale; Alexander Berg; Micki Hill; Jackson Burton; Keith R Abrams; Richard T Abresch; Abby Bronson; Douglass Chapman; Michael Crowther; Tina Duong; Heather Gordish-Dressman; Lutz Harnisch; Erik Henricson; Sarah Kim; Craig M McDonald; Stephan Schmidt; Camille Vong; Xiaoxing Wang; Brenda L Wong; Florence Yong; Klaus Romero
Journal: J Pharmacokinet Pharmacodyn Date: 2019-05-24 Impact factor: 2.745

3. The Traumatic Brain Injury Endpoints Development (TED) Initiative: Progress on a Public-Private Regulatory Collaboration To Accelerate Diagnosis and Treatment of Traumatic Brain Injury.

Authors: Geoffrey T Manley; Christine L Mac Donald; Amy J Markowitz; Diane Stephenson; Ann Robbins; Raquel C Gardner; Ethan Winkler; Yelena G Bodien; Sabrina R Taylor; John K Yue; Lakshmi Kannan; Allison Kumar; Michael A McCrea; Kevin K Wang
Journal: J Neurotrauma Date: 2017-06-27 Impact factor: 5.269

4. Disease Progression Modeling: Key Concepts and Recent Developments.

Authors: Sarah F Cook; Robert R Bies
Journal: Curr Pharmacol Rep Date: 2016-08-15

Review 5. The impact of the Alzheimer's Disease Neuroimaging Initiative 2: What role do public-private partnerships have in pushing the boundaries of clinical and basic science research on Alzheimer's disease?

Authors: Dorothy M Jones-Davis; Neil Buckholtz
Journal: Alzheimers Dement Date: 2015-07 Impact factor: 21.566

Review 6. A review of disease progression models of Parkinson's disease and applications in clinical trials.

Authors: Charles S Venuto; Nicholas B Potter; E Ray Dorsey; Karl Kieburtz
Journal: Mov Disord Date: 2016-05-26 Impact factor: 10.338

Review 7. Innovative Approaches for Slowing Disease Progression in Parkinson's Disease: Takeaways from the 14th Annual International Society for Central Nervous System Clinical Trials and Methodology Scientific Meeting.

Authors: Monica Javidnia; Mark Frasier; Ira Shoulson; Ibrahim Turkoz; Kumar Budur
Journal: Innov Clin Neurosci Date: 2020-01-01

Review 8. New Frontiers in Parkinson's Disease: From Genetics to the Clinic.

Authors: Lamya S Shihabuddin; Patrik Brundin; J Timothy Greenamyre; Diane Stephenson; S Pablo Sardi
Journal: J Neurosci Date: 2018-10-31 Impact factor: 6.167

Review 9. Mild Cognitive Impairment.

Authors: Ronald C Petersen
Journal: Continuum (Minneap Minn) Date: 2016-04

10. Exploring the feasibility of using real-world data from a large clinical data research network to simulate clinical trials of Alzheimer's disease.

Authors: Zhaoyi Chen; Hansi Zhang; Yi Guo; Thomas J George; Mattia Prosperi; William R Hogan; Zhe He; Elizabeth A Shenkman; Fei Wang; Jiang Bian
Journal: NPJ Digit Med Date: 2021-05-14