‘Huddle Up for Alzheimer’s’ Campaign Encourages Clinical Trial Participation

A National Football League broadcaster and former NFL player is urging Americans to “Huddle Up for New Alzheimer’s Treatments” by participating in clinical trials testing new drugs that may potentially treat the degenerative brain disease. The new educational and awareness-raising campaign teams Solomon Wilcots with Axovant Sciences, Ltd., and patient advocacy groups in support of late-stage research such as the Mindset study.

The Phase 3 study, led by Axovant, is evaluating the oral drug RVT-101 in combination with donepezil, a standard therapy, in mild-to-moderate Alzheimer’s disease patients. A control group of patients will receive donepezil treatment alone. This six-month, double-blind Mindset study will be followed by a 12-month open-label extension study, and trial results may be make the drug eligible for approval by the U.S. Food and Drug Administration. The clinical trial (NCT02585934) is currently recruiting and hopes to enroll up to 1,150 Alzheimer’s patients. Its anticipated completion date is October 2017.

RVT-101 has already been included in 13 previous clinical trials and administered to more than 1,250 patients, who tolerated the drug well, the company reports.

“Bringing new Alzheimer’s treatments to market requires the help of patients and caregivers who participate in late-stage clinical research studies,” said the study’s lead researcher, Ilise Lombardo, MD, in a press release.  “Education and teamwork are critical to helping the medical community get potential treatments over the goal line.”

No new drug have been approved in over a decade to treat Alzheimer’s, a disease that affects an estimated 5 million people in the U.S. alone.

The campaign’s launch is timed to pair with activities surrounding Super Bowl 50, set for Feb. 7 in the San Francisco, California, area. The “Huddle Up” video also encourages Alzheimer’s patients and caregivers to confer with their doctors about participating in clinical studies.

http://youtu.be/pgaJT0Q-Hjc%20

In addition to the video, the campaign will include:

• Media and press appearances by Wilcots and the study’s physicians on numerous U.S. news/talk radio and television sports programs during Super Bowl 50 week;
• Former NFL players serving as role models for clinical research participation, with MINDSET physicians conducting Alzheimer’s “lunch and learn” sessions and memory screenings with these players. The first session will be in San Francisco during Super Bowl week;
• Grassroots’ activities through a collaboration with African Americans Against Alzheimer’s, to reach a community poorly represented in late-stage clinical trials. Starting in Miami, Florida, these activities will include productions of “Forget me Not,” Garrett Davis’ play about an African-American family coping with Alzheimer’s.

“African Americans are at least two times more likely to develop Alzheimer’s disease than non-Hispanic, white Americans but have been underrepresented in clinical research studies,” said Stephanie Monroe, executive director of African Americans Against Alzheimer’s. “We need to band together to increase participation in clinical trials of all demographics and encourage African American participation in particular to ensure the development of new safe and effective treatments for patients in all communities. We are excited about playing an important role in this campaign and working to find new treatments for this dreadful disease.”

Wilcots was an NFL defensive back for six seasons, playing for the Pittsburgh Steelers, Cincinnati Bengals (including a Super Bowl appearance) and the Minnesota Vikings, before working as a sports broadcaster.

“Alzheimer’s disease is one of the most tragic health crises of our time and touches all of us through those we know and love,” Wilcots said. “Fortunately, there are several potential treatments in the latest stages of development. With these important clinical trials underway, it’s appropriate to name participants and their caregivers the MVPs in Alzheimer’s drug development.”

He added, “We need to encourage more of them to get and stay involved. The participation of retired NFL players in our campaign provides a model of leadership for the general population who tend to look to us and other professional athletes as sources of guidance and inspiration, including for health and rehabilitation.”

More information about the Mindset clinical trial, including how to participate, is available through this link.