|Friday, February 21|
|PS2 Poster Session II & Refreshments||
Fri, Feb 21, 4:45 PM - 6:15 PM
Developing a Composite Score Sensitive to Clinical Progression in Mild Cognitive Impairment Population Using Partial Least Squares Regression (302785)Shobha Dhadda, Eisai Inc.
Suzanne B Hendrix, Pentara Corporation
Veronika Logovinsky, Eisai Inc.
Carlos Perdomo, Eisai Inc.
Andy Satlin, Eisai Inc.
*Jinping Wang, Eisai Inc
Lu Xu, Eisai Inc.
Keywords: Partial least squares (PLS), Alzheimer’s disease, MCI, mild Alzheimer’s dementia, composite score, clinical efficacy outcome measure, clinical progression, treatment effect
Objectives: No standard clinical trial endpoints exist that are sensitive to change in Mild Cognitive Impairment (MCI) populations. We have developed a composite score with enhanced responsiveness to clinical progression and have further evaluated this score's responsiveness to treatment effects.
Methods: A partial least squares (PLS) regression model used placebo data from 4 MCI studies to select the combination of cognitive and functional items most sensitive to change over 12 months. PLS regression coefficients from the model were used to form a weighted composite score. The composite score was compared with the original scales for responsiveness to progression and sensitivity to treatment effects.
Results: The new composite score consists of 4 ADAS-Cog items, 2 MMSE items and all 6 CDR-SB items. The composite score demonstrates improvements in sensitivity to clinical decline (as measured using standardized change from baseline) of 113%, 89%, and 18% over ADAS-cog, MMSE, and CDR-SB, respectively. CDR-SB demonstrated sensitivity to clinical progression but not to treatment effect. The composite score demonstrated sensitivity to both clinical progression and treatment effect.