title: Protocols to demonstrate slowing of Alzheimer disease progression. Position paper from the International Working Group on Harmonization of Dementia Drug Guidelines. The Disease Progression Sub-Group.
abstract: 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.
authors.affiliation: Eli Lilly & Co., Indianapolis, Indiana, USA.
authors.forename: N
authors.initials: N
authors.lastname: Bodick
authors.forename: F
authors.initials: F
authors.lastname: Forette
authors.forename: D
authors.initials: D
authors.lastname: Hadler
authors.forename: R J
authors.initials: RJ
authors.lastname: Harvey
authors.forename: P
authors.initials: P
authors.lastname: Leber
authors.forename: I G
authors.initials: IG
authors.lastname: McKeith
authors.forename: P J
authors.initials: PJ
authors.lastname: Riekkinen
authors.forename: M N
authors.initials: MN
authors.lastname: Rossor
authors.forename: P
authors.initials: P
authors.lastname: Scheltens
authors.forename: S
authors.initials: S
authors.lastname: Shimohama
authors.forename: R
authors.initials: R
authors.lastname: Spiegel
authors.forename: S
authors.initials: S
authors.lastname: Tanaka
authors.forename: L J
authors.initials: LJ
authors.lastname: Thal
authors.forename: Y
authors.initials: Y
authors.lastname: Urata
authors.forename: P
authors.initials: P
authors.lastname: Whitehouse
authors.forename: G
authors.initials: G
authors.lastname: Wilcock
mesh_terms: D000368:Aged; D000544:Alzheimer Disease / Q000145:classification / Q000175:diagnosis*; D004992:Ethics, Medical; D005260:Female; D015577:Geriatric Assessment / Q000706:statistics & numerical data*; D006801:Humans; D007391:International Cooperation; D008297:Male; D018697:Nootropic Agents / Q000627:therapeutic use*; D017410:Practice Guidelines as Topic; D011594:Psychometrics; D016032:Randomized Controlled Trials as Topic
chemical_list: D018697:Nootropic Agents