To date (2013), we have witnessed over 100 years of research on Alzheimer’s disease (AD). In the past century, this gave new and deep insights into its pathophysiology. However, no new treatment with an innovative mode of action has found its way to the patients since the first targeted therapies with cholinergic drugs like Tacrin. So far A-beta and related targets have shown negative results in pivotal Phase III studies, after showing promising trends in Phase II. Thus the question arises as to whether A-beta is the wrong target for disease-modifying treatments, or whether other substantial changes to clinical development plans need to be made, e.g. including patients at risk of developing AD instead of those already experiencing symptoms. Alternative targets and study design options like enrichment strategies, however, do not evolve as an easy alternative solution.
To date (2013), we have witnessed over 100 years of research on Alzheimer’s disease (AD). In the past century, this gave new and deep insights into its pathophysiology. However, no new treatment with an innovative mode of action has found its way to the patients since the first targeted therapies with cholinergic drugs like Tacrin. So far A-beta and related targets have shown negative results in pivotal Phase III studies, after showing promising trends in Phase II. Thus the question arises as to whether A-beta is the wrong target for disease-modifying treatments, or whether other substantial changes to clinical development plans need to be made, e.g. including patients at risk of developing AD instead of those already experiencing symptoms. Alternative targets and study design options like enrichment strategies, however, do not evolve as an easy alternative solution.
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