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AD/PD 2022 | Improving clinical trials for Alzheimer’s disease therapies

Achieving the goal of finding disease-modifying therapies for Alzheimer’s disease by 2025 requires improvement of clinical trial efficiency. Historically, Phase II and III trials of anti-amyloid therapies used clinical diagnoses for enrolment, resulting in a proportion of the patient cohort lacking the targeted pathology. This led to amyloid positron emission tomography (PET) being used as a standard measure to ensure amyloid presence in the brain. Adam Fleisher, MD, MAS, Eli Lilly and Company, Indianapolis, IN, outlines how the use of biomarkers has since evolved, to identify the patients at the right stage of disease and most suitable for the drug. Tau PET is often also used, as tau is tightly linked to clinical progression and neurodegeneration. These techniques have been combined with fluid biomarkers. There are challenges associated with accessing spinal fluid, so plasma biomarkers have been developed for improved access and efficiency. This interview took place at the AD/PD™ 2022 Conference in Barcelona, Spain.


Dr Fleisher is a full time employee and shareholder of Eli Lilly and Co