FDA to ease AD trial restrictions

The Alzheimer's Association said FDA accepted a working group's recommendations that ease restrictions on the enrollment of patients who have MRI-detected brain abnormalities in trials of Alzheimer's disease candidates targeting beta amyloid. The recommendations include increasing the number of pre-existing microhemorrhages patients may have prior to enrollment to four from two and allowing patients who develop microhemorrhages during a trial to continue receiving treatment, provided that their symptoms do not worsen. Previously, FDA required discontinuation of treatment for any patients who developed abnormalities. In patients who do develop amyloid-related imaging abnormalities, the new recommendations suggest reducing the dose of the study drug. ...