August 2014

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ACT-AD FDA/AD Allies Meeting Proceedings to Be Featured inExpert Review of Neurotherapeutics

ACT-AD is pleased to report that the proceedings of our 2012 and 2013 Annual FDA/AD Allies meetings on combination therapy development for Alzheimer’s disease have been accepted for publication in Expert Review of Neurotherapeutics. The titles below will appear in a special issue of the journal dedicated to therapeutic targets for Alzheimer’s disease. We would like to thank the FDA, Critical Path Institute and the Alzheimer’s Association for their help in making these trail-blazing events possible!

Stephenson D, Perry D, Bens C, Bain L, Berry B, Krams M, Sperling R, Dilts D, Luthman J, Hanna D, McKew J, Temple R, Fox A, Fields F, Salloway S, Katz R. “Charting a path toward combination therapy for Alzheimer’s disease, Exp Rev Neurotherapeutics,” in press.

Perry D, Sperling R, Katz R, Berry D, Dilts D, Hanna D, Salloway S, Trojanowski J, Bountra C, Krams M, Luthman J, Potkin S, Gribkoff V, Temple R, Wang Y, Carrillo M, Stephenson D, Snyder H, Liu E, Ware T, McKew J, Fox A, Fields F, Bain L, Bens C. “Building a roadmap for developing combination therapies for Alzheimer’s disease. Exp Rev Neurotherapeutics,” in press.

FDA PDUFA V Plan on Demographic Data Released

On August 20, the FDA released its PDUFA V-mandated action plan to enhance the collection and availability of demographic subgroup (age, sex, race and ethnicity) data in applications for FDA-regulated medical products. The action plan was developed after an extensive FDA assessment of applications for recently-approved drugs, biologics and medical devices. The agency subsequently engaged in robust interaction with patient groups, provider organizations and industry to determine how participants in clinical trials could better reflect the real-world population and how analysis of subgroup data from clinical trials could yield more information about medical products for the public.

The 27 action items in the plan are intended to address three overarching priorities: to improve the completeness and quality of demographic subgroup data collection, reporting and analysis; to identify barriers to subgroup enrollment in clinical trials and employ strategies to encourage greater participation; and to make demographic subgroup data more available and transparent. The plan is available here. The FDA intends to make additional opportunities for comment available as the plan is implemented.

AFA Caregiver Conference Set for September 12

he Alzheimer’s Foundation of America (AFA) invites you to its third annual free educational conference for family caregivers, health care professionals and individuals with dementia to be held on September 12 in New York City. It includes expert presentations, an exhibit hall, memory screenings and a display of the AFA Quilt to Remember. For more information, please call 866-232-8484 or send an email.

Alzheimer’s Prevention Registry Adds 40,000th Volunteer

We send our congratulations to the Alzheimer’s Prevention Registry. It has achieved a significant milestone as it enrolled its 40,000th volunteer this month. This online registry seeks to “accelerate research by connecting healthy individuals who are committed to preventing Alzheimer’s with scientists carrying out the studies.” If you would like to join the Registry, we encourage you to visit its website and be sure to tell others about it.

AARP and ReACT Host Caregiver Event, September 29

On September 29, AARP and ReACT will host an event called the “Launch of the Caregiver Journey” that will raise awareness about the impact of caregiving. It is at AARP headquarters in Washington, D.C. For more info, go here.

Study Shows Link between DNA Methylation and Alzheimer’s

A study led by researchers at Brigham and Women’s Hospital in Boston, Mass., and Rush University Medical Center in Chicago, Ill., has shown how DNA methylation, the biochemical alternations of the building blocks of DNA, in the brain may play a role in the onset of Alzheimer’s disease. The researchers noted the findings may “help us to better understand the biological impact of environmental risk factors and life experiences on Alzheimer’s disease.” The study was published in Nature Neuroscience.

Researchers Find Area in Brain Associated with Contextual Memories

Researchers at Dartmouth have released a new study in the Journal of Neuroscience that found the region in the brain known as the retrosplenial cortex is a vital area for forming contextual memories. These memories help us recall events and where we were at a certain time. These findings will aid in better understanding how diseases such as Alzheimer’s affect the brain. Learn more here.

7th Annual FDA/Alzheimer’s Disease Allies Meeting Set for November 6th

Make sure you mark November 6, 2014 on your calendars. ACT-AD will host its 7th Annual FDA/Alzheimer’s Disease Allies Meeting for patient groups, regulators, researchers and industry at the Bethesda North Marriott Hotel & Conference Center (5701 Marinelli Rd., Bethesda, MD 20852). This meeting will explore challenges related to clinical meaningfulness in therapeutic development for early Alzheimer’s disease. Check out this page for updates.