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12 - The Importance of Phase 2 in Drug Development for Alzheimer’s Disease

from Section 3 - Alzheimer’s Disease Clinical Trials

Published online by Cambridge University Press:  03 March 2022

By
Philip Scheltens ,
Willem de Haan ,
Roos J. Jutten ,
Everhard Vijverberg ,
Arno de Wilde  and
Niels Prins
Edited by
Jeffrey Cummings ,
Jefferson Kinney  and
Howard Fillit
Jeffrey Cummings
Affiliation:
University of Nevada, Las Vegas
Jefferson Kinney
Affiliation:
University of Nevada, Las Vegas
Howard Fillit
Affiliation:
Alzheimer’s Drug Discovery Foundation
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Summary

Phase 2 in drug development is a crucial phase that can make or break success. The goals in Phase 2 are to determine safety, dosage and efficacy. In this chapter elements of planning, design, biomarker use and clinical outcomes are highlighted and some good and bad examples are given, emphasizing the importance of conducting a proper Phase 2.

Keywords

Alzheimer’s diseaseclinical trialsPhase 2biomarkersEEGbrain imagingcognitive assessment
Type
Chapter
Information
Alzheimer's Disease Drug Development
Research and Development Ecosystem
 , pp. 150 - 161
Publisher: Cambridge University Press
Print publication year: 2022

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