Disease-modifying trials in Alzheimerʹs disease: a European task force consensus

Summary After symptomatic treatments, the new target for therapeutic approaches in Alzheimerʹs disease is the development of disease-modifying drugs. The concept of disease modification in Alzheimerʹs disease is controversial and the design of these trials raises many questions. Which populations should be studied? For how long? With which principal and secondary endpoints? Are surrogate markers available? Here, we present a European consensus on disease-modifying trials in Alzheimerʹs disease, agreed under the auspices of the European Alzheimerʹs Disease Consortium and based on the European perspective of the concept of disease modification, study designs, the role for biomarkers, risk benefit, and pharmacoeconomic issues.