The Alzheimer’s Association Research Roundtable Workgroup has published its findings and conclusions in the current issue of Alzheimer’s & Dementia, including recommendations for conducting clinical trials of amyloid-lowering agents. The group was convened in July 2010 to review publicly available trial data in response to advice from the Food and Drug Administration (FDA) to sponsors conducting clinical trials with amyloid-lowering agents for treating Alzheimer’s. The FDA raised concerns about potential adverse events, specifically cerebral microhemorrhage and vasogenic edema, and recommended discontinuation in patients with any microhemorrhages during the study, advice that appeared stringent and limiting to many researchers.
Prior to publication, the workgroup report was sent to the FDA for review, and the FDA subsequently revised and updated its original advice to sponsors in a manner consistent with the report.
