November 2011

ACT-AD to Hold Annual FDA/AD Allies Meeting on Phase II Trials

ACT-AD will offer another opportunity for patient groups, researchers and industry to interact with the FDA on methods for improving the efficiency of clinical trials for Alzheimer’s disease therapies. The increasing length and size of clinical trials for Alzheimer’s products is impeding patient access to new treatments. This meeting will explore the challenges of Alzheimer’s drug development and potential avenues to improve this process. Individuals involved in current and recent Alzheimer’s trials will reflect upon their experiences designing a Phase II study. These presentations will be followed by a panel discussion.

The meeting is a public event that is co-hosted by The Cure Alzheimer’s Fund and Leaders Engaged on Alzheimer ’s Disease. It will be held on December 9, 2011 from 7:30 a.m. to 2:00 p.m. at the Hilton Rockville Executive Meeting Center in Rockville, MD. There is no fee to attend and all ACT-AD members are encouraged to participate.

For details on how to RSVP for the meeting, click here.

ACT-AD and the Clinical Trials on Alzheimer’s Disease Conference

The 4th Annual Clinical Trials on Alzheimer’s Disease Conference took place in San Diego, California from November 3-November 5, 2011. At this conference, Alzheimer’s leaders involved in clinical trials from around the world gathered to discuss the full spectrum of Alzheimer’s disease from the asymptomatic stage through dementia, the development of the next generation of Alzheimer’s disease treatments and learn to harmonize various neuroimaging techniques and their analyses. The ACT-AD Coalition had a presence in San Diego during the conference.

On November 4, ACT-AD sponsored an informal meeting of leading Alzheimer’s experts attending the conference from the U.S., Europe and Asia. The meeting provided an opportunity for these experts to share their insights into how the development and evaluation of novel AD therapies could be improved. ACT-AD and its members were recognized during this meeting for the work they do to help move the Alzheimer’s field forward on scientific issues that affect the way new therapies are developed and reviewed, as well as to provide forums where thought leaders can present possible solutions to regulators.

ACT-AD Member Releases New Study on Caregiver Health

On November 21, the National Alliance for Caregiving announced the release of its most recent study of family caregivers of people with Alzheimer’s disease. The study, titled Caregiving Costs: Declining Health in the Alzheimer’s Caregiver as Dementia Increases in the Care Recipient, shows a significant decrease in family caregiver health over time as their care recipient’s dementia increases.

While there are existing studies that indicate that the health of family caregivers may be adversely affected, this study specifically examines the use of formal health services in a large sample of Alzheimer’s disease caregivers. The study was conducted by Richard Schulz, PhD, and Thomas Cook, PhD, MPH from the University Center for Social and Urban Research, Department of Psychiatry, University of Pittsburgh in collaboration with the National Alliance for Caregiving.

To view the study, click here.

Congress Acts to Increase Funding for FDA

On November 18, the House and Senate approved a $50 million increase for Food and Drug Administration for Fiscal Year 2012. There was the potential risk of FDA receiving a $285 million decrease that had passed the House of Representatives in June, but they were granted an increase in conference. While this increase is smaller than those the FDA had received in previous appropriations cycles, it was one of only a small number of agencies to do so.

In the back of all FDA advocates minds is the recent failure of the Congressional “Supercommittee” to develop a proposal that would avoid deep and damaging cuts to discretionary programs. FDA falls into this category and under a formula contained in the Budget Control Act (BCA) passed this summer may see budget cuts anywhere between $150 to $250 million (6% to 10%) in FY 2013.

It is essential that ACT-AD and its members continue to press Members of Congress to work toward a bipartisan deficit reduction deal that would make across the board cuts to discretionary programs unnecessary. Given the unique role the FDA plays in promoting and protecting the public’s health, it is critical that we ensure that they have the capacity to continue this important work even in times of budget austerity.

To view the bill that provides the FY 2012 increase, click here.