A NOVEL STUDY PARADIGM FOR LONG-TERM PREVENTION TRIALS IN ALZHEIMER DISEASE: THE PLACEBO GROUP SIMULATION APPROACH (PGSA). APPLICATION TO MCI DATA FROM THE NACC DATABASEM. Berres, W.A. Kukull, A.R. Miserez, A.U. Monsch, S.E. Monsell & R. Spiegel (For The Alzheimer’s Disease Neuroimaging Initiative)
INTRODUCTION: The PGSA (Placebo Group Simulation Approach) aims at avoiding problems of sample representativeness and ethical issues typical of placebo-controlled secondary prevention trials with MCI patients. The PGSA uses mathematical modeling to forecast the distribution of quantified outcomes of MCI patient groups based on their own baseline data established at the outset of clinical trials. These forecasted distributions are then compared with the distribution of actual outcomes observed on candidate treatments, thus substituting for a...
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