Abstract
The field of Alzheimer's disease therapeutic research seems poised to bring to clinic the next generation of treatments, moving beyond symptomatic benefits to modification of the underlying neurobiology of the disease. But a series of recent trials has had disappointingly negative results that raise questions about our drug development strategies. Consideration of ongoing programs demonstrates difficult pitfalls. But a clear path forward is emerging. Successful strategies will utilize newly available tools to reconsider issues of diagnosis, assessment and analysis, facilitating the study of new treatments at early stages in the disease process at which they are most likely to yield major clinical benefits.
Highlights
Alzheimer’s disease (AD) was described just over 100 years ago as an uncommon devastating dementia affecting people in middle age
In the 1970s, Dr Robert Katzman demonstrated that AD is an epidemic of enormous proportions, affecting a substantial segment of the aging population [1]
While a phase II study did suggest a reduction in cerebrospinal fluid Aβ in AD subjects treated with tramiprosate [10], it was unknown whether the degree of reduction would be sufficient to translate into clinical benefit
Summary
Alzheimer’s disease (AD) was described just over 100 years ago as an uncommon devastating dementia affecting people in middle age. The small and brief phase II program was not designed to demonstrate clinically a disease-slowing effect; as expected, subjects in the 12 week treatment trial treated with placebo showed no decline, and, there was no possibility of showing reduced decline with treatment.
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