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Why has therapy development for dementia failed in the last two decades?
Author(s) -
Gauthier Serge,
Albert Marilyn,
Fox Nick,
Goedert Michel,
Kivipelto Miia,
MestreFerrandiz Jorge,
Middleton Lefkos T.
Publication year - 2016
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.2015.12.003
Subject(s) - dementia , drug development , medicine , intensive care medicine , underpinning , disease , nosology , psychiatry , drug , pathology , engineering , civil engineering
The success rate of the pharmaceutical research and development (R&D) for dementia drugs has been abysmally low, in the last two decades. Also low has been the number of pipeline drugs in development, compared to other therapy areas. However, the rationale of early terminations has not been reported in the majority of trials. These are key findings of the recently published pharmaceutical pipeline analysis by the UK‐based Office of Health Economics (OHE). Our understanding of main challenges include (1) the significant gaps of knowledge in the nosology and complexity of the underpinning biological mechanisms of the commonest, not familial, forms of late onset dementias; (2) low signal‐to‐noise ratio, notwithstanding the lack of validated biomarkers as entry and/or end‐point criteria; (3) recruitment and retention, particularly in the asymptomatic and early disease stages. A number of current and future strategies aimed at ameliorating drug development are outlined and discussed.