- 2025-09-02
- Stroke and vascular neurology 11(2)
- Mengyuan Zhou
- Yutian Gong
- Shangrong Han
- Meiping Wang
- Wenping Gu
- Hui-Sheng Chen
- Wenxu Zheng
- Kai Feng
- Dan Wang
- Hang Li
- Zhidong Zheng
- Yuesong Pan
- Weiqi Chen
- Yilong Wang
Study Design
- Type
- Randomized Controlled Trial (RCT)
- Sample size
- n = 114
- Population
- 114 patients with CSVD (57 in each group) with mild cognitive impairment (MoCA score ranging from 16 to 24) associated with CSVD
- Methods
- randomised double-blind, multicentre, placebo-controlled trial; participants randomised 1:1 to orally take 5 g of Cerebralcare pills or placebo twice a day for 6 months
- Blinding
- Double-blind
- Duration
- 6 months
- Funding
- Unclear
Rationale
Cerebral small vessel disease (CSVD) is responsible for 25% of ischaemic strokes and 45% of dementia cases. Currently, therapies targeting individual mechanisms have not shown significant efficacy. As CSVD involves multiple pathophysiological mechanisms, Cerebralcare pills, a traditional Chinese medicine with multiple pharmacological mechanisms, may be effective in treating cognitive dysfunction in CSVD.Aims
The objective of this study was to assess the efficacy of Cerebralcare pills in improving cognitive dysfunction (measured by Montreal Cognitive Assessment (MoCA)) in patients with CSVD.Sample size estimates
A sample size of 114 patients with CSVD (57 in each group) will allow 2.74 points (with an SE of 0.56 points) difference between two groups on the MoCA score with 5% significance, 80% power and assuming a 10% dropout rate.Methods and design
This is a randomised double-blind, multicentre, placebo-controlled trial involving individuals with mild cognitive impairment (MoCA score ranging from 16 to 24) associated with CSVD. CSVD was defined by the presence of white matter hyperintensities consistent with lacunar infarcts or the presence of more than two vascular risk factors. Participants were randomised 1:1 to orally take 5 g of Cerebralcare pills or placebo twice a day for 6 months.Study outcomes
The primary outcome measure is the change in MoCA score at 6 months. Secondary outcome measures include the assessment of clinical manifestations, cognitive performance, conventional MRI markers, blood-brain barrier permeability and proteomics over a follow-up period of 6 months and 12 months.Discussion
The objective of this trial is to evaluate the efficacy of Cerebralcare pills in improving cognitive dysfunction associated with CSVD. Additionally, the trial aims to provide insights into the pathological processes involved in this condition.Trial registration number
NCT05578521.