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Randomized Controlled Trial
. 2020 Apr;16(4):641-650.
doi: 10.1016/j.jalz.2019.08.197. Epub 2020 Jan 16.

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

Marwan Sabbagh  1 , Carl Sadowsky  2 , Babak Tousi  3 , Marc E Agronin  4 , Gustavo Alva  5 , Carmel Armon  6 , Charles Bernick  7 , Andrew P Keegan  8 , Stella Karantzoulis  9 , Eyal Baror  10 , Moran Ploznik  10 , Alvaro Pascual-Leone  11   12
Affiliations
Randomized Controlled Trial

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

Marwan Sabbagh et al. Alzheimers Dement. 2020 Apr.

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.

Keywords: ADAS-Cog; Alzheimer's disease therapeutics; CGI-C; NeuroAD™; TMS.

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References

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