Effects of a combined transcranial magnetic stimulation (TMS) and cognitive training intervention in patients with Alzheimer's disease

Introduction: This clinical trial evaluates the efficacy and safety of a 6-week course of daily neuroAD (TM) therapy. Methods: 131 subjects between 60 and 90 years old, unmedicated for Alzheimer's disease (AD), or on stable doses of an acetylcholinesterase inhibitor and/or memantine, with Mini-Mental State Examination scores between 18 and 26, clinical dementia rating scale scores of 1 or 2, enrolled for a prospective, randomized, double-blind, sham-controlled, multicenter clinical trial. Structural brain MRIs were obtained for transcranial magnetic stimulation targeting. Baseline Alzheimer's disease assessment scale-cognitive (ADAS-Cog) and Clinical Global Impression of Change were assessed. 129 participants were randomized to active treatment plus standard of care (SOC) or sham treatments plus SOC. Results: Subjects with baseline ADAS-Cog <= 30 (similar to 85% of study population) showed a statistically significant benefit favoring active over sham. Responder analysis showed 31.7% participants in the active group with <= -4 point improvement on ADAS-Cog versus 15.4% in the sham group. Discussion: neuroAD (TM) Therapy System provides a low-risk therapeutic benefit for patients with milder AD (baseline ADAS-Cog <= 30) beyond pharmacologic SOC.