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Principal Investigator  
Principal Investigator's Name: Aline Pichon
Institution: Roche
Department: PVSD
Proposed Analysis: In the context of potential safety exploratory analyses in Alzheimer Disease, in collaboration with Roche LeAD team, Andres Schneider, Flavia Brunstein and Yingjia Chen, using the pooled data curated to SDTMv version 3.1.2 from the following Roche internal AD clinical trials and external curated dataset: - ABBY (abe4869g or GN00761) (Crenezumab) - BLAZE (abe4955g or GN00762) (Crenezumab) - Scarlet RoAD double-blind (WN25203) (Gantenerumab) - Marguerite RoAD double-blind (WN28745)(Gantenerumab) - BN29552 (CreAD) (Crenezumab) - BN29553 (CreAD2) (Crenezumab) - ADNI I would like to request access to the latest version of the ADNI dataset Outline of research questions of interest - safety / adverse events angle: Direct and indirect impact through the use antipsychotics in AD subjects and severe adverse events (AEs): - How do severe psychiatric AEs present in the course of AD? - What is the natural history and expected timeline for starting continuous antipsychotic drugs (atypical and conventional) due to severe psychiatric AEs in AD? - What’s the independent effect of these AEs, the continuous use of antipsychotic drugs, the interactions between the two on AD progression in P2M AD population? - What is the mediating effect of continuous use of antipsychotics on the causal pathway of AD diagnosis and AE outcomes? Develop prognostic model with emphasis on AE outcomes in AD (eg., pneumonia or death) while adjusting for other confounding factors (e.g., use of antipsychotics, safety MRI measures) Construct balanced cohorts comparable to those in clinical trials with Gant and Semo between AD patients with and without treatment for background rates estimates of specific AEs (e.g., MRI abnormalities) using propensity score matching or other modeling techniques.
Additional Investigators