Cooperative Agreement U01FD008429

Award Date 9/15/24
Completion Date 8/31/26
Dollars Obligated $1.1M
Federal Grant Program
93.103
Assistance Type
Cooperative Agreement
Place of Performance
Rochester, NY 14611, USA

The University of Rochester received a $1,100,000 Cooperative Agreement award from the U.S. Food and Drug Administration (FDA) under the FDA Research program (CFDA 93.103) to measure digital clinical endpoints in Huntington's disease (HD). The project, titled "MEASURING DIGITAL CLINICAL ENDPOINTS IN HUNTINGTON'S DISEASE (MEND-HD)," aims to demonstrate the reliability, validity, and meaningfulness of two key digital measures - daily living mobility (gait) and chorea - captured remotely and continuously using wearable sensors in individuals with early-stage HD. The study will also explore other digital measures such as daily physical activity, heart rate variability, and sleep quality. This cross-sectional study will involve 40 individuals with early HD and 20 control participants, with the long-term objective of establishing these digital measures as drug development tools and treatment response endpoints in early HD. The University of Rochester has also awarded a sub-grant to Teachers College Columbia University to support this project.

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