磁刺激
美金刚
痴呆
医学
临床试验
临床痴呆评级
随机对照试验
人口
临床全球印象
评定量表
疾病
物理疗法
刺激
心理学
内科学
病理
发展心理学
替代医学
环境卫生
安慰剂
作者
Marwan N. Sabbagh,Carl Sadowsky,Babak Tousi,Marc Agronin,Gustavo Alva,Carmel Armon,Charles Bernick,Andrew P. Keegan,Stella Karantzoulis,Eyal Baror,Moran Ploznik,Álvaro Pascual‐Leone
标识
DOI:10.1016/j.jalz.2019.08.197
摘要
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.
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