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Challenges, solutions, and recommendations for Alzheimer's disease combination therapy
Author(s) -
Hendrix James A.,
Bateman Randall J.,
Brashear H. Robert,
Duggan Cynthia,
Carrillo Maria C.,
Bain Lisa J.,
DeMattos Ronald,
Katz Russell G.,
Ostrowitzki Susanne,
Siemers Eric,
Sperling Reisa,
Vitolo Ottavio V.
Publication year - 2016
Publication title -
alzheimer's and dementia
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 6.713
H-Index - 118
eISSN - 1552-5279
pISSN - 1552-5260
DOI - 10.1016/j.jalz.2016.02.007
Subject(s) - disease , medicine , alzheimer's disease , intensive care medicine
Given the complex neuropathology Alzheimer's disease (AD), combination therapy may be necessary for effective treatment. However, scientific, pragmatic, regulatory, and business challenges need to be addressed before combination therapy for AD can become a reality. Leaders from academia and industry, along with a former member of the Food and Drug Administration and the Alzheimer's Association, have explored these challenges and here propose a strategy to facilitate proof‐of‐concept combination therapy trials in the near future. First, a more integrated understanding of the complex pathophysiology and progression of AD is needed to identify the appropriate pathways and the disease stage to target. Once drug candidates are identified, novel clinical trial designs and selection of appropriate outcome assessments will be needed to enable definition and evaluation of the appropriate dose and dosing regimen and determination of efficacy. Success in addressing this urgent problem will only be achieved through collaboration among multiple stakeholders.