Advantage of cerebellar intermittent theta-burst stimulation in Alzheimer's disease (ACT-AD): study protocol for a multicenter, randomized, double-blind, sham-controlled trial.

IF 2.1 4区医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL

Trials Pub Date : 2026-10-09 DOI:10.1186/s13063-026-10009-w

Xin Zhang, Wen Li, Zhongqing Sun, Xiaomu Wang, Changgeng Song, Xiaorui Wang, Yinuo Niu, Dong Wei, Wei Zhang, Gejuan Zhang, Bei Zhang, Ling Wang, Zhirong Liu, Jingjing Zhao, Wen Jiang

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引用次数: 0

Abstract

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.

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小脑间歇性爆发刺激治疗阿尔茨海默病（ACT-AD）的优势：一项多中心、随机、双盲、假对照试验的研究方案

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来源期刊

Trials 医学-医学：研究与实验

CiteScore

3.80

自引率

4.00%

发文量

966

审稿时长

6 months

期刊介绍： Trials is an open access, peer-reviewed, online journal that will encompass all aspects of the performance and findings of randomized controlled trials. Trials will experiment with, and then refine, innovative approaches to improving communication about trials. We are keen to move beyond publishing traditional trial results articles (although these will be included). We believe this represents an exciting opportunity to advance the science and reporting of trials. Prior to 2006, Trials was published as Current Controlled Trials in Cardiovascular Medicine (CCTCVM). All published CCTCVM articles are available via the Trials website and citations to CCTCVM article URLs will continue to be supported.