March 2013

NIH to Hold Alzheimer’s Disease-Related Dementias Research Conference

The National Institute of Neurological Disorders and Stroke (NINDS) will host a conference on May 1-2, 2013 titled Alzheimer’s Disease-Related Dementias: Research Challenges and Opportunities. At the conference leading neuroscientists, physicians, and public and private stakeholders will solicit input and develop recommendations on special research priorities and timelines for addressing Alzheimer’s disease-related dementias. Organized by the NINDS in collaboration with the National Institute on Aging (NIA) the conference is convened under the 2012 National Plan to Address Alzheimer’s Disease to develop recommendations on research priorities in the areas of frontotemporal, Lewy body, mixed, and vascular dementias, and is complementary to NIA’s Alzheimer’s Disease Research Summit 2012.

ACT-AD is a sponsor of the May conference, and encourages all members to attend. The conference will be held at the Natcher Conference Center on the National Institute of Health’s Bethesda, MD campus.

For more information and to register online, click here.

FDA Clarifies Guidance on Early Stage Alzheimer’s Therapy Approval

This month Russell Katz, M.D. and Nicholas Kozauer, M.D. of the FDA’s Division of Neurology Products published an article in the New England Journal of Medicine (NEJM), clarifying the agency’s proposed guidance to industry for designing and conducting clinical trials involving patients with early Alzheimer’s disease.

The draft guidance opens the door to the use of a single scale combining assessments of both cognition and function for those in trials at the earliest stages of Alzheimer’s disease. The proposal also suggests that approval of a therapy based on such outcomes alone could conceivably be achieved through the FDA’s accelerated approval pathway.

Drs. Katz and Kozauer stated that the accelerated pathway, “may hold promise” for those therapies that show efficacy in early stages of the disease, and may be of the greatest benefit to the steadily increasing number of people with, and at risk for, the devastating disease. Drs. Katz and Kozauer were subsequently featured in a webinar organized by the FDA’s Office of Medical Policy on March 28, where they further reviewed the guidance.

ACT-AD will be submitting comments on the draft guidance. Comments are due on April 9, 2013.

To read the NEJM article, click here.

For the full draft guidance, click here.

SAVE THE DATE: May 28-30, 2013 ACT-AD Expert Consensus Retreat on Combination Therapies

On November 29, ACT-AD hosted its fifth working meeting with senior representatives from the U.S. Food and Drug Administration (FDA), leading scientists, drug developers, and Alzheimer’s advocates to address critical issues affecting the development and review of new Alzheimer’s disease therapies. The meeting, co-hosted by the Critical Path Institute (C-Path), focused on how to foster more robust pre-competitive collaboration in Alzheimer’s disease in order to encourage the development of combination therapies and bring new treatments to market. The meeting explored the challenges of these collaboration and potential opportunities for future partnership.

There was emerging consensus at the meeting that now is the time for pursuing combination therapy development for Alzheimer’s disease. Collaboration will be essential for achieving combination development and while challenges to collaboration among industry partners are formidable, they are not insurmountable. The group decided that the next step for the field is to come together through an intensive, consensus-building process for achieving the shared vision of treating and preventing Alzheimer’s disease.

Based on the meeting recommendations, ACT-AD is organizing a follow-on retreat to generate a roadmap for how this shared vision can become a reality through combination therapy. The meeting will take place on May 28-30 at the Grand Hyatt in Washington, DC. Additional information will be available in the April issue of the Alzheimer’s Advocate and on www.act-ad.org.

The final report from the November 29 ACT-AD/C-Path meeting can be found here.