FDA position statement “Early Alzheimer's disease: Developing drugs for treatment, Guidance for Industry”

Alzheimer's and Dementia: Translational Research and Clinical Interventions - Tập 5 - Trang 13-19 - 2019
Marwan N. Sabbagh1, Suzanne Hendrix2, John E. Harrison3,4,5
1Cleveland Clinic Lou Ruvo Center for Brain Health, Las Vegas, NV, USA.
2Pentara, Salt Lake City UT, USA
3Principal Consultant at Metis Cognition Ltd, Kilmington, UK
4Associate Professor at the Alzheimer Center, VUmc, Amsterdam, The Netherlands
5Visiting Professor Department of Psychological Medicine, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London

Tóm tắt

AbstractDespite billions of dollars invested in clinical trials to develop novel therapeutics for Alzheimer's disease, no approved treatments have been developed in the past 15 years. In that span, new classes of drugs have been developed and tested, including monoclonal antibodies, γ‐secretase modulators, γ‐secretase inhibitors, BACE inhibitors, RAGE inhibitors, nicotinic agonists, 5HT6 antagonists, and others. The one constant for all of these clinical trials programs is the use of the ADAS‐cog as the primary scale to determine efficacy. The question that needs to be considered is whether it is the target engagement of the drug or the clinical trial measure testing the efficacy. The FDA put out a new position statement in 2018 informing the field on possible considerations for demonstrating efficacy to open the path for approval. Here, we propose and comment on a variety of approaches that are alternatives to the ADAS for FDA‐specified stage 3 and 4 Alzheimer's disease. These novel outcomes are being validated in current clinical trials and could be used as efficacy measures moving forward.

Tài liệu tham khảo

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Alzheimer's and Dementia: Translational Research and Clinical Interventions

Tập 5

13-19

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