TY - JOUR
T1 - Effects of a combined transcranial magnetic stimulation (TMS) and cognitive training intervention in patients with Alzheimer's disease
AU - Sabbagh, Marwan
AU - Sadowsky, Carl
AU - Tousi, Babak
AU - Agronin, Marc E.
AU - Alva, Gustavo
AU - Armon, Carmel
AU - Bernick, Charles
AU - Keegan, Andrew P.
AU - Karantzoulis, Stella
AU - Baror, Eyal
AU - Ploznik, Moran
AU - Pascual-Leone, Alvaro
N1 - Publisher Copyright:
© 2020 the Alzheimer's Association
PY - 2020/4/1
Y1 - 2020/4/1
N2 - 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.
AB - 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.
KW - ADAS-Cog
KW - Alzheimer's disease therapeutics
KW - CGI-C
KW - NeuroAD™
KW - TMS
UR - http://www.scopus.com/inward/record.url?scp=85076854169&partnerID=8YFLogxK
U2 - 10.1016/j.jalz.2019.08.197
DO - 10.1016/j.jalz.2019.08.197
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C2 - 31879235
AN - SCOPUS:85076854169
SN - 1552-5260
VL - 16
SP - 641
EP - 650
JO - Alzheimer's and Dementia
JF - Alzheimer's and Dementia
IS - 4
ER -