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

Alzheimer's & Dementia - Tập 16 Số 4 - Trang 641-650 - 2020
Marwan N. Sabbagh1, Carl Sadowsky2, Babak Tousi3, Marc Agronin4, Gustavo Alva5, Carmel Armon6, Charles Bernick7, Andrew P. Keegan8, Stella Karantzoulis9, Eyal Baror10, Moran Ploznik10, Álvaro Pascual‐Leone11,12
1Camille and Larry Ruvo Chair for Brain Health, Cleveland Clinic Lou Ruvo Center for Brain Health, Las Vegas, NV, USA
2Premier Research Institute and NOVA SE University, Fort Lauderdale, FL, USA
3Cleveland Clinic Lou Ruvo Center for Brain Health, Cleveland, OH, USA
4Behavioral Health and Clinical Research, Miami Jewish Health Systems, Miami, FL, USA
5ATP Clinical Research, Costa Mesa, CA, USA
6Department of Neurology, Tel Aviv University Sackler School of Medicine and Shamir (Assaf Harofeh) Medical Center, Be'er Ya'akov, Israel
7Cleveland Clinic Lou Ruvo Center for Brain Health, Las Vegas, NV, USA.
8Roskamp Institute, Sarasota, FL, USA
9ModernBrain Center for Neuropsychological Services, New York, NY, USA
10Neuronix Ltd., Yoqneam, Israel
11Guttmann Brain Health Institut, Institut Gutmann, Universitat Autonoma, Barcelona, Spain
12Hinda and Arthur Marcus Institute for Aging Research and Center for Memory Health, Hebrew Senior Life Department of Neurology, Harvard Medical School, Boston, MA, USA

Tóm tắt

AbstractIntroductionThis clinical trial evaluates the efficacy and safety of a 6‐week course of daily neuroAD™ therapy.Methods131 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.ResultsSubjects 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.DiscussionneuroAD™ Therapy System provides a low‐risk therapeutic benefit for patients with milder AD (baseline ADAS‐Cog ≤30) beyond pharmacologic SOC.

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Alzheimer's & Dementia

Tập 16 Số 4

641-650

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