Marwan Sabbagh1, Carl Sadowsky2, Babak Tousi3, Marc E Agronin4, Gustavo Alva5, Carmel Armon6, Charles Bernick7, Andrew P Keegan8, Stella Karantzoulis9, Eyal Baror10, Moran Ploznik10, Alvaro Pascual-Leone11,12. 1. Camille and Larry Ruvo Chair for Brain Health, Cleveland Clinic Lou Ruvo Center for Brain Health, Las Vegas, NV, USA. 2. Premier Research Institute and NOVA SE University, Fort Lauderdale, FL, USA. 3. Cleveland Clinic Lou Ruvo Center for Brain Health, Cleveland, OH, USA. 4. Behavioral Health and Clinical Research, Miami Jewish Health Systems, Miami, FL, USA. 5. ATP Clinical Research, Costa Mesa, CA, USA. 6. Department of Neurology, Tel Aviv University Sackler School of Medicine and Shamir (Assaf Harofeh) Medical Center, Be'er Ya'akov, Israel. 7. Cleveland Clinic Lou Ruvo Center for Brain Health, Las Vegas, NV, USA. 8. Roskamp Institute, Sarasota, FL, USA. 9. ModernBrain Center for Neuropsychological Services, New York, NY, USA. 10. Neuronix Ltd., Yoqneam, Israel. 11. Hinda and Arthur Marcus Institute for Aging Research and Center for Memory Health, Hebrew Senior Life Department of Neurology, Harvard Medical School, Boston, MA, USA. 12. Guttmann Brain Health Institut, Institut Gutmann, Universitat Autonoma, Barcelona, Spain.
Abstract
INTRODUCTION: This clinical trial evaluates the efficacy and safety of a 6-week course of daily neuroAD™ 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 (~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™ Therapy System provides a low-risk therapeutic benefit for patients with milder AD (baseline ADAS-Cog ≤30) beyond pharmacologic SOC.
RCT Entities:
INTRODUCTION: This clinical trial evaluates the efficacy and safety of a 6-week course of daily neuroAD™ 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 (~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™ Therapy System provides a low-risk therapeutic benefit for patients with milder AD (baseline ADAS-Cog ≤30) beyond pharmacologic SOC.
Authors: Marina Weiler; Perla Moreno-Castilla; Hannah M Starnes; Edward L R Melendez; Kevin C Stieger; Jeffrey M Long; Peter R Rapp Journal: Brain Stimul Date: 2021-08-13 Impact factor: 9.184
Authors: Arianna Menardi; Simone Rossi; Giacomo Koch; Harald Hampel; Andrea Vergallo; Michael A Nitsche; Yaakov Stern; Barbara Borroni; Stefano F Cappa; Maria Cotelli; Giulio Ruffini; Georges El-Fakhri; Paolo M Rossini; Brad Dickerson; Andrea Antal; Claudio Babiloni; Jean-Pascal Lefaucheur; Bruno Dubois; Gustavo Deco; Ulf Ziemann; Alvaro Pascual-Leone; Emiliano Santarnecchi Journal: Ageing Res Rev Date: 2021-12-30 Impact factor: 11.788