Substantial clinical and biomarker data from late-stage anti-amyloid programs signals a promising new era for AD drug development and provides compelling evidence for the prominent role of neurotoxic soluble amyloid oligomers in the pathogenesis of AD and as therapeutic targets. Considering the pressing need, regulators have shown increasing engagement with drug developers and potential flexibility with respect to conditions and criteria for drug approval. A recent draft guidance from the US FDA on demonstrating substantial evidence of effectiveness [52] seems to allow more flexibility in the evidentiary standards of efficacy.

Read PDF: Tolar (2020) First Wave of Effective DM Drugs for AD - Alzheimer's Research & Therapy 12 AUG 2020 PUBLISHED.pdf