Acupuncture for amnestic mild cognitive impairment (aMCI): study protocol for a pilot multicenter, randomized, parallel controlled trial
Bibliographic record
Abstract
Abstract Background: Patients with amnesic mild cognitive impairment (aMCI) are more likely to develop Alzheimer's disease (AD) than corresponding age normal population. Because AD is irreversible, early intervention for aMCI patients seems important and urgent. We have designed a pilot multicenter, randomized, parallel controlled trial to assess the efficacy and safety of acupuncture on aMCI, and explore the feasibility of acupuncture in the treatment of aMCI, so as to provide a reference for large-sample clinical trials in the next stage. Method: We designed a pilot multicenter, randomized, parallel controlled trial. This trial aims to test the feasibility of carrying out a large-sample clinical trial. In this trial, 50 eligible patients with aMCI will be included and allocated to acupuncture group (n = 25) or sham acupuncture group (n = 25) at random. Subjects will accept treatment 2 times a week for 12 weeks continuously, with a total of 24 treatment sessions. We will select six acupoints (GV20, GV14, bilateral BL18 , bilateral BL23). For the clinical outcomes, the primary outcome is Montreal cognitive assessment (MoCA), which will be assessed from baseline to the end of this trial. And the secondary outcomes are Mini-mental State Examination (MMSE), Delayed Story Recall (DSR), Clinical Dementia Rating scale (CDR), Global Deterioration Scale (GDS), Activity of Daily Life (ADL), Alzheimer's Disease Assessment Scale-Cognitive Section (ADAS-cog), brain Magnetic Resonance Imaging (MRI) , brain functional Magnetic Resonance Imaging (fMRI) and Event-related potential (ERP) P300, which will be assessed before and after treatment. In addition, we will asses the safety outcomes from baseline to the end of this trial and feasibility outcome after treatment. We will evaluate neuropsychological assessment scale (MoCA, MMSE, ADAS-cog) at 3 months and 6months after treatment. Discussion: This pilot trial aims to explore the feasibility of the trial, and verify essential information of its efficacy and safety. This pilot study will provide a preliminary basis for carrying out a larger clinical trial of acupuncture on aMCI in near future. Trial registration: Chinese Clinical Trial Registry , ChiCTR1900021557. Registered on 27 February 2019, http://www.chictr.org.cn/showproj.aspx?proj=35460. Keywords: amnestic Mild Cognitive Impairment , Acupuncture, Clinical trial
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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 | 0.040 | 0.087 |
| Meta-epidemiology (narrow) | 0.004 | 0.002 |
| Meta-epidemiology (broad) | 0.012 | 0.005 |
| Bibliometrics | 0.004 | 0.002 |
| Science and technology studies | 0.003 | 0.004 |
| Scholarly communication | 0.001 | 0.000 |
| Open science | 0.002 | 0.006 |
| Research integrity | 0.001 | 0.010 |
| Insufficient payload (model declined to judge) | 0.001 | 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; both teacher heads agree on what is shown here.
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".