CerebrAlcare Pills on CereBral Small VesseL DiseasE (CABLE) trial: rationale and design
Bibliographic record
Abstract
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.
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How this classification was reachedexpand
Full frame distilled prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.000 | 0.000 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.000 | 0.000 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.000 |
| Insufficient payload (model declined to judge) | 0.000 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one teacher head, not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".