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Protocols to demonstrate slowing of Alzheimer Disease progression: position paper from the International Working Group on Harmonization of Dementia Drug Guidelines

journal contribution
posted on 1997-01-01, 00:00 authored by N Bodick, F Forette, D Hadler, Richard HarveyRichard Harvey, P Leber, I G McKeith, P J Riekkinen, M N Rossor, P Scheltens, S Shimohama, R Spiegel, S Tanaka, L J Thal, Y Urata, P Whitehouse, G Wilcock
Two suggested clinical trial designs for assessing progression of Alzheimer disease are the randomized withdrawal design and the randomized start design. The most promising of these, the randomized start design, has the potential to demonstrate a delay in progression, but there remain problematic design, ethical, and statistical issues to be solved before the protocol can be used in a clinical trial. The development of biological markers of the disease process using neuroimaging or other measures also may provide a robust method of measuring disease progression and demonstrating the biological effect of a drug on the disease process.

History

Journal

Alzheimer disease and associated disorders

Volume

11

Issue

Suppl 3

Pagination

50 - 53

Publisher

Wolters Kluwer

Location

Philadelphia, Pa.

ISSN

0893-0341

Language

eng

Publication classification

C1.1 Refereed article in a scholarly journal

Copyright notice

1997, Lippincott-Raven Publishers

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