Optimizing Effect Sizes in Mild Alzheimer’s Disease Clinical Trials (P2.227) (original) (raw)

Neurology, 2016

Abstract

Objective: To determine the effect of extended Alzheimer9s Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) and amyloid imaging standardized uptake value ratio (SUVR) thresholds on clinical trial effect size. Background: Recent clinical trials of anti-beta amyloid interventions have used extended versions of the ADAS-Cog as outcome measures and positive positron emission tomography (PET) imaging with a ligand specific for beta amyloid as inclusion criteria, in part, in an effort to increase the sensitivity to detect treatment effects in mild AD. The implications on trial statistical power, however, remain uncertain. Methods: We used data from mild AD participants (Mini-Mental Status Exam 20-26) in the Alzheimer’s Disease Neuroimaging Initiative (ADNI) to model trial effect sizes (Δμ/σ) for 12- and 24-month trials using the ADAS-Cog11, 12 and 13 as the primary outcome. The ADAS-Cog11 incorporates tests of memory and language in addition to other cognitive abilities. ADAS-Cog12 ...

Edmond Teng hasn't uploaded this paper.

Let Edmond know you want this paper to be uploaded.

Ask for this paper to be uploaded.