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Peer-reviewedCC BY 4.0Trials

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

3 more authors

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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BibTeX
@article{zhang2026advantage,
  title = {{Advantage of cerebellar intermittent theta-burst stimulation in Alzheimer's disease (ACT-AD): study protocol for a multicenter, randomized, double-blind, sham-controlled trial}},
  author = {Xin Zhang and Wen Li and Zhongqing Sun and Xiaomu Wang and Changgeng Song and Xiaorui Wang and Yinuo Niu and Dong Wei and Wei Zhang and Gejuan Zhang and Bei Zhang and Ling Wang and Zhirong Liu and Jingjing Zhao and Wen Jiang},
  journal = {Trials},
  year = {2026},
  month = oct,
  doi = {10.1186/s13063-026-10009-w},
  url = {https://link.springer.com/10.1186/s13063-026-10009-w},
  note = {CC BY 4.0},
}
RIS
TY  - JOUR
TI  - Advantage of cerebellar intermittent theta-burst stimulation in Alzheimer's disease (ACT-AD): study protocol for a multicenter, randomized, double-blind, sham-controlled trial
AU  - Xin Zhang
AU  - Wen Li
AU  - Zhongqing Sun
AU  - Xiaomu Wang
AU  - Changgeng Song
AU  - Xiaorui Wang
AU  - Yinuo Niu
AU  - Dong Wei
AU  - Wei Zhang
AU  - Gejuan Zhang
AU  - Bei Zhang
AU  - Ling Wang
AU  - Zhirong Liu
AU  - Jingjing Zhao
AU  - Wen Jiang
PY  - 2026
DA  - 2026/10/09
JO  - Trials
DO  - 10.1186/s13063-026-10009-w
UR  - https://link.springer.com/10.1186/s13063-026-10009-w
AB  - 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.
SN  - 1745-6215
ER  -