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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

Lookup NU author(s): Professor Ian McKeith


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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.

Publication metadata

Author(s): McKeith IG; Bodick N; Forette F; Hadler D; Harvey RJ; Leber P; Riekkinen PJ; Rossor MN; Scheltens P; Shimohama S; Spiegel R; Tanaka S; Thal LJ; Urata Y; Whitehouse P; Wilcock G

Publication type: Article

Publication status: Published

Journal: Alzheimer Disease and Associated Disorders

Year: 1997

Volume: 11

Pages: 50-53

Print publication date: 01/01/1997

ISSN (print): 0893-0341

ISSN (electronic): 1546-4156

Publisher: Lippincott Williams & Wilkins