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Commentary on “A roadmap for the prevention of dementia: The inaugural Leon Thal Symposium.” An impending prevention clinical trial for Alzheimer's disease: Roadmaps and realities
Author(s) -
Roses Allen D.
Publication year - 2008
Publication title -
alzheimer's and dementia
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 6.713
H-Index - 118
eISSN - 1552-5279
pISSN - 1552-5260
DOI - 10.1016/j.jalz.2008.03.007
Subject(s) - citation , library science , medicine , gerontology , computer science
I have been invited to briefly comment on “A Roadmap to Prevention of Dementia.” Leon Thal and I last met at an Arizona ADRC Advisory Committee in April 2006, and we initiated a conversation regarding what an Alzheimer’s disease prevention study for an oral drug or nutrichemical might look like. The rosiglitazone–Alzheimer’s disease (AD) Phase III program was just underway, with several 48-week trials based on a pharmacogenetic design: randomization by APOE genotype in thousands of patients. I had sought his advice, knowing his interest and his propensity for straightforward discussion. We left each other that weekend when he flew home, after he demonstrated the filing of a flight plan on his computer. We had plenty of time to talk because the rosiglitazone trials would not end soon— last patient in, last patient out— until late 2008. Tragically we were wrong about our remaining time. From 1997 through 2007 I participated in drug discovery and drug development priority decisions as a member of the GSK Research and Development Executive Committee. With the perspective of living in a world in which priority setting and incentives are powerful elements of choices, I was struggling with the design of a possible AD prevention trial and the need for exclusivity incentives to encourage the company to consider prioritizing such a trial. Although folks like to wax poetic about possible scenarios, I was dealing with some realistic constraints, intimately tied to regulatory issues and return on investment considerations. Discussions with regulators had begun, the jury of the Phase III trials was still out, but preplanning might accelerate action immediately on the heels of drug approval. Leon Thal, for me, was a friend from outside of that world who had an understanding of the influences of cost, regulatory interactions, incentives, risks, and competition, all of which are intimately involved in any expensive prevention undertaking.