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Guidance Offers IDE Tips For Devices Targeting Brain Disease Progression

FDA issued a draft guidance to help device-makers conduct clinical trials for products designed to slow the progress of neurological conditions. One challenge highlighted by the agency is that changes to biomarkers measured in a study may not line up easily with disease progression.

Clinical trials of devices designed to slow the progression of neurological conditions such as Alzheimer’s disease shouldn’t conflate symptom improvement with biomarker changes, FDA underscores in a March 7 draft guidance.

The draft addresses investigational device exemption clinical considerations for devices targeting the cause or progression, rather than the symptoms, of diseases including Alzheimer's, Parkinson's and primary dystonia. It is intended...

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