Project Abstract Millions of patients with Alzheimer’s disease (AD) suffer from sleep disturbances that significantly degrade their quality of life and amplifies the heavy emotional burden on caregivers. Restless Legs Syndrome (RLS) is likely a factor for the sleep disturbance in these patients, however, RLS is currently difficult to diagnose, particularly in patients with AD. The diagnosis is made clinically with subjective, patient reports and the symptoms themselves are variable across individuals. Thus, patients with AD who may already have difficulty with verbal expression are especially vulnerable to being misdiagnosed. Furthermore, recent studies suggest that nighttime agitations (a particularly troublesome symptom of AD that leads to early institutionalization) may be a manifestation of undiagnosed and therefore unmanaged RLS. RestEaze is an ankle-worn wearable technology and mobile application developed by Tanzen Medical Inc to measure leg movements during sleep that are highly related to RLS and can serve as an objective biomarker of the condition. The device is industrially designed to be comfortably worn by the patient and washable to permit extended, nightly use. The mobile application is easy to use by the patient (or caregiver) to interact with and store data from the device. The read-out provided to the clinician provides clear, actionable information that quantifies the patients’ leg movements during sleep in reference to American Academy of Sleep Medicine standards. In sum, RestEaze directly addresses a significant unmet medical need by providing a technology that can substantially improve the diagnosis and subsequent management of RLS in patients with AD. The use of this technology is expected to improve the quality of life for patients with AD and their caregivers by directly addressing their sleep disturbance and preventing the need for early institutionalization or other ancillary medical services.

Project Narrative Restless Legs Syndrome (RLS) is a significant contributor to sleep problems in patients with Alzheimer’s disease (AD). Unfortunately, current medical practice results in a significant underdiagnosis of RLS in patients with AD, leaving them untreated or worse, treated for the wrong condition. The RestEaze technology developed in this proposal will address this gap by providing clinicians information on a patient’s leg movements during sleep which they can then use to help accurately diagnose and treat patients with AD who are suffering from RLS.