December 2008

A Look Back on 2008

As 2008 draws to a close, it is an appropriate time to reflect on the work of ACT-AD and recognize some key steps that were taken this year to help facilitate patient access to interventional Alzheimer’s treatments.

In March, Alzheimer’s researchers, FDA officials, ACT-AD members, and other stakeholders came together in Rockville, MD to advance the discussion around clinical meaningfulness in new Alzheimer’s therapies. The meeting was the first of its kind and a success in that it challenged FDA’s current standard for defining clinical meaningfulness in Alzheimer’s disease and called attention to the need for further examination of this issue as new Alzheimer’s therapies are being developed to intervene earlier in the disease course.

The 11th Annual International Conference on Alzheimer’s Disease (ICAD) took place in Chicago, IL this past July. For the first time ACT-AD had a presence at the conference, hosting a gathering for prominent Alzheimer’s disease experts. The focus of this discussion was how best to improve the development and evaluation of Alzheimer’s treatments. ACT-AD significantly expanded its reach within the scientific community as a result of this event.

In September, 21 prominent clinicians, including Dr. John Morris of Washington University St. Louis and Dr. Dennis Selkoe of Harvard Medical School, sent a letter to the FDA on the topic of biomarker use in Alzheimer’s clinical trials. They said that several neuro-imaging and biochemical biomarkers are ready for accelerated validation and use. Like the members of ACT-AD, these clinicians believe that by playing a more proactive role in developing consensus around the use of biomarkers, FDA can encourage wider use of these tools which have the potential to improve many aspects of AD clinical trials.

Finally, ACT-AD joined with more than 80 advocacy groups in urging Congress to increase funding for FDA this year. With a continuing resolution signed by the President and a fiscal year 2008 budget surplus, FDA will see an overall budget increase of $300 million. We hope that some of this funding will be applied to activities, infrastructure, and additional neurology expertise that could enhance Alzheimer’s therapy review at FDA.

ACT-AD and others in the Alzheimer’s community have had a positive year. We look forward to 2009 and hope for continued success in fulfilling our mission of ensuring that more effective treatments and a cure for Alzheimer’s disease are made available to patients and their. We could not do this with out the support of our coalition members. We thank you all for your efforts.