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Abstract: Our research has shown that the tolerance of Alzheimer's disease (AD) patients for
anti-dementia compounds is frequently higher but occasionally lower than the tolerance of healthy young
or elderly populations. Such differences can either pose safety problems in later efficacy studies if
patients cannot tolerate the dosages previously deemed 'safe' in healthy populations, or interfere with
determining efficacy if inadequate doses are employed. We recommend use of a 'bridging study', which
optimizes dosage early in development by determining the maximum tolerated dose of a compound in
patients. Consecutive panels of patients each receive higher doses of study drug until a minimum
intolerated dose is reached. The dose immediately below this one is then considered the maximum
tolerated dose. Careful subject selection, adequate facilities, and highly qualified, experienced personnel
are critical to the successful implementation of a bridging study. Correctly done, bridging can streamline
the overall drug development process while making Phase II and III trials safer for patients, and has
immense potential for accelerating the search for compounds that have efficacy in AD.
Subjects:
EMBASE® (Excerpta Medica)
© 1997 Elsevier Science B.V. All rights reserved.
Dialog® File Number 72 Accession Number 10249693