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TRanscranial AlterNating current Stimulation FOR patients with Mild Alzheimer's Disease (TRANSFORM-AD study): Protocol for a randomized controlled clinical trial.

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机构: [1]Innovation Center for Neurological Disorders Department of Neurology, Xuanwu Hospital Capital Medical University National Clinical Research Center for Geriatric Diseases Beijing China. [2]Key Laboratory of Neurodegenerative Diseases Ministry of Education of the People's Republic of China Beijing China. [3]Department of Neurosurgery Xuanwu Hospital Capital Medical University Beijing China. [4]Department of Radiology Xuanwu Hospital Capital Medical University Beijing China.
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Recently, transcranial alternating current stimulation (tACS), which can interact with ongoing neuronal activity, has emerged as a potentially effective and promising treatment for Alzheimer's disease (AD), and the 40 Hz gamma frequency was suggested as a suitable stimulation frequency for AD. The TRANSFORM-AD study is a double-blind, randomized-controlled trial that will include 40 individuals with mild AD. Eligible patients need to have amyloid β (Aβ) loads examined by Pittsburgh compound B (PiB) positron emission tomography (PET) or decreased Aβ level in cerebrospinal fluid. Participants will be randomized into either a 40 Hz tACS group or a sham stimulation group. Both groups will undergo 30 one-hour sessions across 3 weeks (21 days). The outcome measures will be assessed at baseline, at the end of the intervention, and 3 months after the first session. The primary outcome is global cognitive function, assessed by the 11-item cognitive subscale of the Alzheimer's Disease Assessment Scale (ADAS-Cog), and the secondary outcomes include changes in other neuropsychological assessments and in PiB-PET, structural magnetic resonance imaging (MRI), resting electroencephalography (EEG), and simultaneous EEG-functional MRI (EEG-fMRI) results. The trial is currently ongoing, and it is anticipated that recruitment will be completed in June 2021. This trial will evaluate the efficacy and safety of 40 Hz tACS in patients with AD, and further explore the potential mechanisms by analyzing amyloid deposits using PiB-PET, brain volume and white matter integrity by structural MRI, and neural activity by EEG and EEG-fMRI. © 2020 The Authors. Alzheimer's & Dementia: Translational Research & Clinical Interventions published by Wiley Periodicals, Inc. on behalf of Alzheimer's Association.

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第一作者机构: [1]Innovation Center for Neurological Disorders Department of Neurology, Xuanwu Hospital Capital Medical University National Clinical Research Center for Geriatric Diseases Beijing China. [2]Key Laboratory of Neurodegenerative Diseases Ministry of Education of the People's Republic of China Beijing China.
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通讯机构: [*1]Department of Neurology & Innovation Center for Neurological Disorders, Xuanwu Hospital, CapitalMedical University, 45 Changchun Street, Beijing 100053, China.
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