The Food and Drug Administration (FDA) Neurologic Devices Advisory Panel voted unanimously (14-0) not to recommend approval of transcranial magnetic stimulation (TMS) plus cognitive training exercises (NeuroAD; Neuronis, Washington, DC) for treatment of Alzheimer’s disease (AD). The application for approval was through the FDA Expedited Access Pathway (EAP) program, reserved for potentially breakthrough and novel devices that could meet a life-threating or irreversibly disabling unmet medical need.
The device is approved and available to patients in Europe, Australia, and Israel. The treatment combines TMS to brain areas affected in AD with individually tailored computer-based cognitive exercises. The stimulated brain areas include Broca’s and Wernicke’s areas involved in language; the dorsolateral prefrontal cortex involved in judgment, executive functions and long-term memory; and the parietal somatosensory association cortex involved in orientation and praxis.
The panel’s reasoning for not recommending approval was primarily based on FDA reviewers’ concerns that in the pivotal trial, treatment with the device resulted in lower gains in cognition assessment scores compared with sham treatment. The FDA reviewers also expressed concerns to the panel regarding study methodology and data analysis, which including pooled clinical data from studies in Israel and the US. The panel did not have any concerns regarding safety of the device.
Eyal Baror, Neuronix CEO and President said, "We appreciate the thoughtful consideration of the neuroAD data as well as the needs of the Alzheimer's disease community of patients and caregivers. We are pleased that the committee recognized the safety of the device, but we are disappointed that the panel's feedback on our clinical studies and data analysis may result in neuroAD not being available in the US in the foreseeable future."