December 2014

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​ACT-AD Submits Comments on FDA PDUFA V Initiative

ACT-AD has submitted comments to the U.S. Food and Drug Administration on a proposed list of disease areas for patient-focused drug development meetings during fiscal years 2016-2017. The patient-focused drug development meetings held to date covered aspects of diseases that are most important to those living with them and resulted in valuable publicly-available resources written in the voice of patients to help inform new endpoint development, outcome measure selection in clinical trials, and benefit/risk decision making by the FDA. The comments urge the FDA to add Alzheimer’s to the list of nominated diseases and ask the organization to prioritize a meeting on the condition in early FY 2016. (Read More)

 ACT-AD Offers Insights on Aging Well in 21st Century

ACT-AD has sent a letter to the National Institute on Aging (NIA) about its draft strategic directions document, Aging Well in the 21st Century. The letter thanked the NIA’s director for the priority he has placed on advancing Alzheimer’s disease research and the commitment the NIA has shown to collaborating with other partners to more quickly translate research findings into new treatment options for people living with Alzheimer’s disease. ACT-AD encouraged the NIA to include greater emphasis on research to develop improved tools for measuring cognition and function in early stage AD and on advancing combination drug therapy for the condition in the Institute’s final strategic plan. (Read More)

ACT-AD Science Advisory Board Member Gives Keynote Address at CTAD Conference

CT-AD Science Advisory Board member Russell “Rusty” Katz, M.D., delivered a memorable keynote speech at the Clinical Trials in Alzheimer’s Disease (CTAD) conference in late November that drew widespread acclaim from attendees. Dr. Katz called on researchers to focus more on achieving large therapeutic effects through combination trials and less emphasis on disease modification. (Read More)

Psoriasis Drug Could Stimulate Alzheimer’s-Fighting Enzyme

Researchers at the University Medical Center of Johannes Gutenberg University Mainz (JGU) have recently discovered a drug that is used to treat psoriasis also stimulates activity of the ADAM10 enzyme in the brains of Alzheimer’s patients. There is evidence that this enzyme could suppress the effect of Alzheimer’s. The findings were published in the journal Neurology(Read More)

NIH Issues Draft Policy Promoting IRBs

The National Institutes of Health has released a draft policy that promotes use of single institutional review boards (IRBs) for clinical research studies being conducted in multiple sites. According to the NIH, “Wider use of single IRB review in multi-site studies will help achieve greater efficiencies in the initiation of studies across NIH’s entire clinical research portfolio.”

Study: Midlife Diabetes Accelerates Rate of Cognitive Decline

A study from the Johns Hopkins Bloomberg School of Public Health reveals those who develop diabetes in midlife, and control it poorly, may encounter an increased rate of cognitive decline over the next 20 years. Researchers found study participants with diabetes in midlife were 19 percent more likely to experience decline than those the same age and without the condition. It was published in the Annals of Internal Medicine. (Read More)

Keeping Microglia ‘On the Job’ Could Ward Off Alzheimer’s

Microglia, brain cells that act much like immune cells, play a role in combating Alzheimer’s, according to experts at Stanford University School of Medicine. They found “that blocking the action of a single molecule on the surface of microglia restored the cells’ ability to get the job done and reversed memory loss and myriad other Alzheimer’s-like features in the animals.” The study was published in The Journal of Clinical Investigation. (Read More)