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Abstract
After intense scientific exploration and more than a decade of failed trials, Alzheimer’s disease (AD) remains a fatal global epidemic. A traditional research and drug development paradigm continues to target heterogeneous late-stage clinically phenotyped patients with single 'magic bullet' drugs. Here, we propose that it is time for a paradigm shift towards the implementation of precision medicine (PM) for enhanced risk screening, detection, treatment, and prevention of AD. The overarching structure of how PM for AD can be achieved will be provided through the convergence of breakthrough technological advances, including big data science, systems biology, genomic sequencing, blood-based biomarkers, integrated disease modeling and P4 medicine. It is hypothesized that deconstructing AD into multiple genetic and biological subsets existing within this heterogeneous target population will provide an effective PM strategy for treating individual patients with the specific agent(s) that are likely to work best based on the specific individual biological make-up.
The Alzheimer’s Precision Medicine Initiative (APMI) is an international collaboration of leading interdisciplinary clinicians and scientists devoted towards the implementation of PM in Neurology, Psychiatry and Neuroscience. It is hypothesized that successful realization of PM in AD and other neurodegenerative diseases will result in breakthrough therapies, such as in oncology, with optimized safety profiles, better responder rates and treatment responses, particularly through biomarker-guided early preclinical disease-stage clinical trials.
Conflict of interest
H. H. declares no competing financial interests related to the present article. He serves as Senior Associate Editor for the journal Alzheimer’s & Dementia®; he has been a scientific consultant and/or speaker and/or attended scientific advisory boards of Axovant, Anavex, Eli Lilly and company, GE Healthcare, Cytox, Jung Diagnostics, Roche, Biogen Idec, Takeda-Zinfandel, Oryzon Genomics; and receives research support from the Association for Alzheimer Research (Paris), Pierre and Marie Curie University (Paris), Pfizer & Avid (paid to institution); and has patents as co-inventor, but received no royalties: A patent in vitro multiparameter determination method for the Diagnosis and early diagnosis of neurodegenerative disorders. Patent number: 8916388 Issued. A patent in vitro procedure for diagnosis and early diagnosis of neurodegenerative diseases. Patent number: 8298784 Issued. A patent Neurodegenerative Markers for Psychiatric Conditions. Publication number: 20120196300 Issued. A patent In vitro multiparameter determination method for the diagnosis and early diagnosis of neurodegenerative disorders. Publication number: 20100062463 Issued. A patent In vitro method for the diagnosis and early diagnosis of neurodegenerative disorders. Publication number: 20100035286 Issued. A patent In vitro Procedure for Diagnosis and Early Diagnosis of Neurodegenerative Diseases. Publication number: 20090263822 Issued. A patent in vitro method for the diagnosis of neurodegenerative diseases. Patent number: 7547553 Issued. A patent CSF diagnostic in vitro method for diagnosis of dementias and neuroinflammatory diseases. Publication number: 20080206797 Issued. A patent in vitro method for the diagnosis of neurodegenerative diseases. Publication number: 20080199966 Issued. A patent Neurodegenerative markers for psychiatric conditions. Publication number: 20080131921 Issued. S. E. O. has the following patents pending related to precision medicine: PCT/US2011/036496 and PCT/US2014/067562 (additional patent filed). He has served on an advisory board for and received honoraria from Roche and has equity in Cx Precision Medicine, Inc. V. E. P. reports personal fees from Cytox Ltd. J. C. C. declares no competing financial interests related to the present article. He has been scientific consultant for BMS, Zambon, Pfizer, Abbvie, Ipsen, Clevexel, Amarantus, and received research grants from the Michael J Fox Foundation, French Ministry of Health, French Ministry of Research. He owns stock options from B&A Therapeutics. B. D. reports personal fees from Eli Lilly. S. L. has received lecture honoraria from Roche. E. Y., S. D., K. R. and K. B. reports no conflicts of interest.
Source of funding
H. H. and J. C. C. are supported by the AXA Research Fund, the Fondation Université Pierre et Marie Curie and the Fondation pour la Recherche sur Alzheimer, Paris, France. The research leading to these results has received funding from the program ‘Investissements d’avenir’ ANR-10-IAIHU-06 (H. H., J. C. C.).
S. E. O. is supported by the National Institute on Aging of the National Institutes of Health under Award Numbers R01AG051848 and R56AG054073. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.
S. D. is funded by the European Research Council (ERC) under grant agreement No 678304, European Union’s Horizon 2020 research and innovation program under grant agreement No 666992, and the program ‘Investissements d’avenir’ ANR-10-IAIHU-06.