December 2015


Congress Passes FY 2016 Appropriations Bill, Good News for Alzheimer’s Disease Research

After protracted dispute and prolonged negotiation, Congress reached a deal on a $1.1 trillion omnibus spending bill for FY 2016. The bill is a positive step for regulators and Alzheimer’s disease researchers. The National Institute on Aging (NIA) receives a $400 million boost for FY 2016 from its FY 2015 level. Of this total, $350 million is directed for Alzheimer’s disease and related dementias research. Overall, Alzheimer’s-directed funding jumps nearly 60 percent from FY 2015. In addition, the U.S. Food and Drug Administration receives $2.7 billion, an increase of $133 million over FY 2015 levels. Read the bill here.

Stakeholder Consultation on FDA User Fee Reauthorization Continues, ACT-AD Represented

The U.S. Food and Drug Administration (FDA) held two meetings this month with representatives from patient and consumer advocacy organizations to discuss progress in its negotiations with industry on the sixth reauthorization of the prescription drug user fee program and the fourth reauthorization of the medical device user fee program. Cynthia Bens and Ryne Carney represented ACT-AD at both of these meetings. In prepared remarks, Bens called for the expansion of existing mechanisms at FDA’s Center for Drug Evaluation and Research to encourage greater patient and caregiver input into endpoint development as part of PDUFA VI.  Bens also focused on the need for additional staff at the Center for Devices and Radiological Health through MDUFA IV to evaluate patient-reported outcome data and other patient preference information. These prepared remarks can be found here for PDUFA and here for MDUFA.

ACT-AD Executive Director Joins Panel on FDA and Patient Centeredness

On December 15, ACT-AD’s Executive Director, Cynthia Bens, spoke on a panel titled “FDA and Patient Centeredness: A Work in Progress” at the FDA/CMS Summit for Biopharma Executives in Washington, D.C. She was joined by representatives from Parent Project Muscular Dystrophy, the National Alliance for Caregiving, the National Health Council, and Bristol-Myers Squibb. Bens offered insights from ACT-AD’s decade of experience working with FDA on Alzheimer’s disease therapeutic development issues and shared her perspective on how FDA can expand its Patient-Focused Drug Development Initiative to incorporate innovative activities being led by patient advocacy organizations and industry. You can learn more about the conference here. 

NIA Releases Alzheimer’s Disease Progress Report

The National Institute on Aging (NIA) released its 2014-2015 “Alzheimer’s Disease Progress Report: Advancing Research Toward a Cure.” It offers an update on the latest NIH-supported Alzheimer’s disease research initiatives, objectives, and advances from 2014 and early 2015. The report also includes scientific content found in the first-ever “NIH Bypass Budget Proposal for Fiscal Year 2017,” which estimates the additional funding needed to reach the U.S. national goal to effectively treat and prevent Alzheimer’s and related dementias by 2025. You can access the progress report here.

New Study Finds Anti-Androgen Drugs Could Be Linked to Increased Alzheimer’s Disease Risk

A new study published in the Journal of Clinical Oncology warns about a possible link between the use of anti-androgen drugs to treat prostate cancer and Alzheimer’s disease. The study notes, “Results support an association between the use of ADT in the treatment of prostate cancer and an increased risk of Alzheimer’s disease in a general population cohort.” Learn more here.

Experts Examine Connection between Gait Speed and Alzheimer’s Disease

Experts have found that there may be a connection between gait speed and Alzheimer’s disease. In an article published in the journal Neurology, researchers say that slower walking speeds among older adults are associated with higher levels of amyloid plaques in the brain. A total of 128 older adults considered at high risk for memory problems, but without a formal dementia diagnosis, were examined by the experts. Read more here.

Negative Beliefs about Aging Could Contribute to Development of Alzheimer’s Disease, Say Yale Experts

Those who have negative impressions about aging could be more susceptible to changes in the brain connected to Alzheimer’s disease. These are the findings of a study conducted by experts from Yale University and published online in the journal Psychology and Aging.  “We believe it is the stress generated by the negative beliefs about aging that individuals sometimes internalize from society that can result in pathological brain changes,” says lead study author Dr. Becca Levy. “Although the findings are concerning, it is encouraging to realize that these negative beliefs about aging can be mitigated and positive beliefs about aging can be reinforced, so that the adverse impact is not inevitable.” Read more here.