New findings suggest that an investigational device that combines transcranial magnetic stimulation (TMS) with cognitive training may improve cognitive performance in individuals with Alzheimer’s disease. The double-blind, placebo-controlled clinical study, explored the potential of the NeuroAD Therapy system (Neuronix) in 131 patients with mild to moderate Alzheimer’s disease. The study specifically evaluated the system’s safety and efficacy in comparison to placebo, following six weeks of treatment and additional six weeks of follow-up. In patients with milder disease, representing 85 percent of the enrolled population, researchers noted a statistically significant difference of -1.8 points in ADAS-Cog was noted between treatment group and placebo group, at the 12-week follow-up. In the entire cohort, including those with more severe disease at baseline based on the ADAS-Cog, results did not reach statistical significance. Additionally, CGI-C results in the overall population showed a trend toward improvement at 12 weeks, with a difference between treatment and placebo groups of -0.4 points. When analyzing the group of milder patients, as defined above, the difference between treatment and placebo groups reached -0.45. When measured on the CGI-C scale, only 16 percent of treated patients deteriorated, compared with 42 percent of patients in the placebo group.
The investigators also noted favorable safety outcomes, with no patients experiencing seizures or other persistent, serious adverse events. Patients also showed a high degree of adherence to the treatment, with few discontinuations and a high rate of treatment completion, according to the company.
The results were used to support a FDA de-novo application filed in November 2016, seeking regulatory clearance to market the neuroAD Therapy System for treatment of Alzheimer's disease. Previously, the neuroAD Therapy System was accepted for review under the Expedited Access Pathway (EAP) program. The system is currently approved for use in Europe (CE Marked 0482) and is commercially available in leading Alzheimer's centers in Europe and Asia.Next Story