ATRI-012, Longitudinal Follow-Up of Clinical Trial Participants for Brain Donation

Abstract The elements of this study (regular contact with prior ACTC study participants and study partners, collection of some cognitive testing information, autopsy neuropathologic evaluation and banking of tissue for future research purposes) are intended to enhance the information gained from clinical studies. The ongoing gathering of cognitive functional information is intended to bridge the gap regarding clinical status between the final visit of an ACTC or affiliated clinical trial and death, while allowing for logistical planning for eventual autopsy. The diagnostic aspects of the autopsy will be provided to the family and physicians involved in the care of the patient, with the goal of helping them understand the causative disease process. By providing comparable information to the trial, issues of diagnostic accuracy as well as biological actions of interventions will be able to be assessed. Finally, these tissues will become an important biospecimen resource for future studies, although access to the repository will be handled through separate research protocols.