Fig. 4: Illustration of the prognostic enrichment procedure in a clinical trial.
From: Forecasting individual progression trajectories in Alzheimer’s disease
Participants are selected first using standard inclusion criteria and undergo a series of exams. A disease progression model, such as AD Course Map, then forecasts the progression of each participant’s data and predicts if the participant is likely to progress significantly during the trial, as measured by the predicted outcome change, which is the mini-mental state examination (MMSE) in this example. The treatment effect (e.g., a 25% reduction of the change of the MMSE during trial) leads to a greater effect size, and therefore a smaller sample size, on the group of predicted fast progressors compared to the group of predicted slow progressors or the two groups combined. As a result, one may demonstrate the treatment efficacy with fewer participants by monitoring only the group of predicted fast progressors.
