Title

Translational Scoring of Candidate Treatments for Alzheimer’s Disease: A Systematic Approach

Document Type

Article

Publication Date

6-8-2020

Publication Title

Dementia and Geriatric Cognitive Disorders

First page number:

1

Last page number:

16

Abstract

Background: There are many failures in treatment development for Alzheimer’s disease (AD). Some of these failures are the result of development programs that lacked critical information about candidate drugs as these were advanced from one phase of development to the next. Translational scoring (TS) has been proposed as a means of increasing the rigor with which treatment development programs are executed. Previously, these approaches were not specific to AD or to the phase of drug development. Detailed information on the characteristics needed to advance a candidate agent from one phase to the next is the basis for success in subsequent phases. Summary: The TS approach is presented with a score range of 0–25 for agents entering phases 1, 2, and 3 of development and those that have completed phase 3 and are being considered for regulatory review. Each phase has 5 essential categories scored from 0–5 indicating the completeness of the data available when the agent is being considered for promotion to the next phase. Lower scores suggest that the development program should be reexamined for missing information while higher scores increase the confidence that the agent has the potential to succeed in the next phase. Scoring guidelines are provided and examples of scores for drugs in recent development programs are provided to illustrate the principles of TS. Key Messages: Successful development of drugs for AD treatment requires disciplined informed decision-making at each phase of development. TS is a methodology for more rigorous drug development to help ensure that inadequately characterized drugs are not advanced and that the development platform at each phase is optimal to support success at the next phase.

Keywords

Alzheimer’s disease; Clinical trials; Drug development; Translational scoring; Biomarkers; Target product profile; Toxicity

Disciplines

Cognitive Neuroscience | Medical Neurobiology

Language

English

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