The need for thorough phase II studies in medicines development for Alzheimer's disease.

Instead the decision to move to phase III has at times been made based on positive data on effects on biomarkers rather than clinical endpoints: an example here is that of solanezumab [ 2 ], where after entering phase III studies based on biomarker and safety data in phase II, the first phase III results did not reach statistical significance (though the study led to design of the further ongoing phase III study in mild patients).

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