Protocols to demonstrate slowing of Alzheimer disease progression - Position paper from the International Working Group on Harmonization of Dementia Drug Guidelines

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 de...

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Main Authors: Bodick, N, Forette, F, Hadler, D, Harvey, R, Leber, P, McKeith, I, Riekkinen, P, Rossor, M, Scheltens, P, Shimohama, S, Spiegel, R, Tanaka, S, Thal, L, Urata, Y, Whitehouse, P, Wilcock, G
Format: Journal article
Published: 1997
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author Bodick, N
Forette, F
Hadler, D
Harvey, R
Leber, P
McKeith, I
Riekkinen, P
Rossor, M
Scheltens, P
Shimohama, S
Spiegel, R
Tanaka, S
Thal, L
Urata, Y
Whitehouse, P
Wilcock, G
author_facet Bodick, N
Forette, F
Hadler, D
Harvey, R
Leber, P
McKeith, I
Riekkinen, P
Rossor, M
Scheltens, P
Shimohama, S
Spiegel, R
Tanaka, S
Thal, L
Urata, Y
Whitehouse, P
Wilcock, G
author_sort Bodick, N
collection OXFORD
description 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. © 1997 Lippincott-Raven Publishers.
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spelling oxford-uuid:42b9fc7e-922c-455d-9e8c-d395fc9ecca62022-03-26T14:51:12ZProtocols to demonstrate slowing of Alzheimer disease progression - Position paper from the International Working Group on Harmonization of Dementia Drug GuidelinesJournal articlehttp://purl.org/coar/resource_type/c_dcae04bcuuid:42b9fc7e-922c-455d-9e8c-d395fc9ecca6Symplectic Elements at Oxford1997Bodick, NForette, FHadler, DHarvey, RLeber, PMcKeith, IRiekkinen, PRossor, MScheltens, PShimohama, SSpiegel, RTanaka, SThal, LUrata, YWhitehouse, PWilcock, GTwo 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. © 1997 Lippincott-Raven Publishers.
spellingShingle Bodick, N
Forette, F
Hadler, D
Harvey, R
Leber, P
McKeith, I
Riekkinen, P
Rossor, M
Scheltens, P
Shimohama, S
Spiegel, R
Tanaka, S
Thal, L
Urata, Y
Whitehouse, P
Wilcock, G
Protocols to demonstrate slowing of Alzheimer disease progression - Position paper from the International Working Group on Harmonization of Dementia Drug Guidelines
title Protocols to demonstrate slowing of Alzheimer disease progression - Position paper from the International Working Group on Harmonization of Dementia Drug Guidelines
title_full Protocols to demonstrate slowing of Alzheimer disease progression - Position paper from the International Working Group on Harmonization of Dementia Drug Guidelines
title_fullStr Protocols to demonstrate slowing of Alzheimer disease progression - Position paper from the International Working Group on Harmonization of Dementia Drug Guidelines
title_full_unstemmed Protocols to demonstrate slowing of Alzheimer disease progression - Position paper from the International Working Group on Harmonization of Dementia Drug Guidelines
title_short Protocols to demonstrate slowing of Alzheimer disease progression - Position paper from the International Working Group on Harmonization of Dementia Drug Guidelines
title_sort protocols to demonstrate slowing of alzheimer disease progression position paper from the international working group on harmonization of dementia drug guidelines
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