July 2016


ICYMI: ACT-AD Webinar on Clinical Meaningfulness Available Online

On July 19, ACT-AD presented an expert webinar on clinical meaningfulness. It included Russell “Rusty” Katz, M.D., Cristina Sampaio, M.D., Ph.D., and Yaakov Stern, Ph.D., who discussed the history of co-primary outcomes for demonstrating clinical meaningfulness in overt dementia and the complexity of applying the co-primary endpoint paradigm in patient populations at earlier stages of the disease. The program was moderated by ACT-AD Executive Director Cynthia Bens. In case you missed it, you can watch it here.

FDA Releases Commitment Letter for PDUFA Reauthorization

This month the U.S. Food and Drug Administration (FDA) released its Prescription Drug User Fee Act Reauthorization Performance Goals and Procedures, Fiscal Years 2018-2022 document, commonly called the PDUFA commitment letter. The commitment letter includes areas of agreement between the FDA and industry on enhancements to the user fee program in its sixth reauthorization. Some areas of importance to patients include a greater focus on methods for advancing patient-focused drug development, exploring the use of real world evidence in regulatory decision making, and adding resources to continue the breakthrough therapy pathway. There are elements that ACT-AD has supported through participation in monthly stakeholder meetings with the FDA on PDUFA VI. The FDA will hold a large public meeting on August 16 to seek further input. ACT-AD’s Executive Director Cynthia Bens was invited to speak on a panel during this meeting. To read the entire document, please go here. Information on FDA’s public meeting and how to submit comments can be found here.

Recent Study Says Specialized Brain Training May Forestall Alzheimer’s Disease

The results of a clinical trial have led researchers to conclude that brain-training exercises could cut the risk of cognitive decline or dementia in half. The findings are the result of a 10-year study, funded by the National Institute on Aging, that compared the effects of multiple forms of brain training among “2,802 cognitively healthy seniors.” Learn more here.

Get Highlights from AAIC Conference

The Alzheimer’s Association International Conference® 2016 was held on July 22-28 in Toronto, Canada. It drew experts, students, care providers, and others from more than 70 countries worldwide. ACT-AD was represented at the conference. Presentations during the conference included members of ACT-AD’s Science Advisory Board involved in Alzheimer’s disease prevention studies, as well as many ACT-AD sponsors who are conducting Alzheimer’s treatment trials. If you weren’t able to make it to this year’s conference, you can learn what happened at the conference’s media highlights webpage.

Save the Date for ACT-AD’s Ninth Annual FDA/AD Allies Meeting/November 16

Mark your calendars! ACT-AD’s Ninth Annual FDA/AD Allies Meeting is set for Wednesday, November 16, 2016, at the Bethesda North Marriott Hotel and Conference Center (5701 Marinelli Road, North Bethesda, Maryland, 20852) Get more information here.