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- W2005472328 abstract "Future clinical trials in prodromal AD are expected to rely on CDR as an important efficacy endpoint. Sensitivity of the CDR in the prodromal population is favorable compared to other common clinical endpoints. Statistical models for the longitudinal progression of CDR scores provide a basis for more insightful analysis of clinical trial data, as well as a basis for better prospective understanding of the operating characteristics of candidate trial designs through simulating from the model. Models that describe CDR progression as a function of demographic and biomarker covariates may be used to evaluate the likely impact of various trial enrichment strategies through simulation. Simulation-based trial design has already been successfully applied in the context of mild-to-moderate AD, and our current effort seeks to enable similar approaches for prodromal AD. The CDR is comprised of 6 subscores, but analysis of the CDR often focuses on an aggregate score, the sum of boxes, that weights each item equally. Recent approaches improve upon this using item response theory (IRT), and we extended the IRT approach to include longitudinal and covariate data. Patient subscores were modeled using a graded-response IRT model, where progression was captured as change in the latent disease status over time, controlled by baseline covariates. Modeling the joint progression of individual item responses allowed for better understanding of the item sensitivity in different subpopulations, at different stages of the disease. To illustrate, Figure 1 shows the progression of the probability of a subscore being greater than zero for a patient with baseline MMSE of 29 with (in order of increasing sensitivity): personal care, community affairs, home and hobbies, orientation, judgement and problem solving, and memory. The longitudinal aspect of the model facilitated quantification of progression rates to later stages of dementia, and the covariate model allowed further quantification within subpopulations." @default.
- W2005472328 created "2016-06-24" @default.
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- W2005472328 date "2013-07-01" @default.
- W2005472328 modified "2023-09-27" @default.
- W2005472328 title "P3-301: Clinical dementia rating modeling and simulation: Modeling and simulation of CDR progression in the ADNI cohort based on item response theory" @default.
- W2005472328 doi "https://doi.org/10.1016/j.jalz.2013.05.1376" @default.
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