Trials · 2026
Advantage of cerebellar intermittent theta-burst stimulation in Alzheimer's disease (ACT-AD): study protocol for a multicenter, randomized, double-blind, sham-controlled trial.
СтатьяПротокол клинического исследованияНазвание и аннотация: Перевод пока не подготовлен
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Zhang Xin, Li Wen, Sun Zhongqing, Wang Xiaomu, Song Changgeng, Wang Xiaorui, Niu Yinuo, Wei Dong, Zhang Wei, Zhang Gejuan, Zhang Bei, Wang Ling, Liu Zhirong, Zhao Jingjing, Jiang Wen
Аннотация
INTRODUCTION: The cerebellum plays a crucial role in cognitive processing and thus presents a promising therapeutic target for Alzheimer's disease (AD). This trial aims to evaluate the efficacy and safety of long-term, neuronavigated cerebellar intermittent theta burst stimulation (iTBS) in patients with AD.
METHODS AND ANALYSIS: The ACT-AD trial is a multicenter, randomized, double-blind, sham-controlled study involving 100 participants with mild-to-moderate AD across 4 centers in China. Participants will be randomized to receive either cerebellar iTBS or sham stimulation for 4 weeks (daily sessions), followed by 8 weeks of weekly maintenance sessions. The primary outcome is the change in the Clinical Dementia Rating Scale Sum of Boxes (CDR-SB) score from baseline to week 12. Secondary outcomes include additional clinical scales. Exploratory outcomes include electroencephalogram (EEG), blood biomarkers and magnetic resonance imaging (MRI). Statistical analysis will follow intention-to-treat principles using mixed models for repeated measures (MMRM).
DISCUSSION: The ACT-AD trial will assess the efficacy and safety of long-term, neuronavigated cerebellar iTBS in treating patients with mild-to-moderate AD.
TRIAL REGISTRATION: ClinicalTrials.gov, NCT06669182. Registered on 31 October 2024.
METHODS AND ANALYSIS: The ACT-AD trial is a multicenter, randomized, double-blind, sham-controlled study involving 100 participants with mild-to-moderate AD across 4 centers in China. Participants will be randomized to receive either cerebellar iTBS or sham stimulation for 4 weeks (daily sessions), followed by 8 weeks of weekly maintenance sessions. The primary outcome is the change in the Clinical Dementia Rating Scale Sum of Boxes (CDR-SB) score from baseline to week 12. Secondary outcomes include additional clinical scales. Exploratory outcomes include electroencephalogram (EEG), blood biomarkers and magnetic resonance imaging (MRI). Statistical analysis will follow intention-to-treat principles using mixed models for repeated measures (MMRM).
DISCUSSION: The ACT-AD trial will assess the efficacy and safety of long-term, neuronavigated cerebellar iTBS in treating patients with mild-to-moderate AD.
TRIAL REGISTRATION: ClinicalTrials.gov, NCT06669182. Registered on 31 October 2024.