Cleveland Clinic Opens Alzheimer Prevention Center, Avalglucosidase Alfa Meets End Point, FDA Grants Breakthrough to MedRhythms

This week's Neurology News Network covered Cleveland Clinic's new Women's Alzheimer's Movement Prevention Center, results of avalglucosidase alfa in patients with late-onset Pompe disease, and the FDA granted MedRhythms with breakthrough device designation.

Welcome to this special edition of Neurology News Network. I’m Marco Meglio. Please excuse our appearance this week as a majority of the US workforce, including the NeurologyLive team, moves to working remote as we come together to help reduce the spread of the novel coronavirus.

In conjunction with the Women's Alzheimer's Movement, or WAM, Cleveland Clinic has announced they have opened The Women's Alzheimer's Movement Prevention Center, the first Alzheimer's prevention clinic designed just for women. Building on peer-reviewed science indicating that up to one-third of all Alzheimer’s cases might be preventable through risk-reduction strategies, The Women’s Alzheimer’s Prevention Center is the first medical clinic in the nation to offer a women-specific center for Alzheimer’s disease prevention, research and caregiving support. Maria Shriver, founder of WAM, is the visionary behind The Women’s Alzheimer’s Prevention Center, which is located within Cleveland Clinic Lou Ruvo Center for Brain Health in Las Vegas, Nev. The Women’s Alzheimer’s Prevention Center is for women of all ages who may have a risk for Alzheimer’s disease due to family history or are concerned about their risk and want to minimize it.

Sanofi has announced that its investigational enzyme replacement therapy, avalglucosidase alfa, was associated with clinically meaningful improvements in respiratory impairment and decreased mobility in patients with late-onset Pompe disease. The company noted that these data will be the basis for global regulatory submissions, including to the FDA, in the second half of 2020. The data, from the phase 3 COMET trial, show that avalglucosidase alfa met the primary end point of the study in demonstrating non-inferiority in improving respiratory function compared to standard of care with alglucosidase alfa.

The FDA has granted a breakthrough device designation to MedRhythms for its patented digital therapeutic to treat walking deficits associated with chronic stroke. The impact of the device is currently being assessed in a randomized controlled trial at 5 rehabilitation sites in the US. MedRhythms’ device is a sensor-automated, music-based, rhythmic locomotor training platform designed to monitor cadence and promote progress to higher speeds through systematic increases in the tempo of music (in headphones) based on the patient’s ability to match their cadence to the rhythmic music stimuli. The intervention serves as a digitized version of a therapy known as rhythmic auditory stimulation.

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