Taxifolin for prevention of COGnitive impairment (T-COG trial): a study protocol for a randomized, double-blind, placebo-controlled trial
Bibliographic record
Abstract
Introduction Anti-β-amyloid antibody therapy, recanemab and donanemab, have been approved for mild cognitive impairment and mild dementia in several countries. However, these therapies merely slow cognitive decline rather than improve cognitive function, despite successfully eliminating accumulated β-amyloid. This suggests that elimination of β-amyloid is insufficient for cognitive improvement. Therefore, novel treatments with pleiotropic neuroprotective effects are warranted. Taxifolin, bioactive flavonoid, shows pleiotropic effects, such as inhibition of amyloid-β aggregation and oligomerization, and hippocampal neuroinflammation, and stimulation brain lymphatic vessel formation in our experimental studies. However, clinical evidence remains limited. Methods Before the start of the Taxifolin for prevention of COGnitive impairment (T-COG) trial, our preliminary observational study without placebo shows oral taxifolin intake is associated with cognitive improvement using Montreal Cognitive Assessment among patients with mild cognitive impairment or mild dementia. No adverse events were observed. Results Based on the findings in our preliminary study, we will conduct T-COG trial that is a single-center, placebo-controlled, randomized, double-blind, placebo-controlled, crossover trial involving patients with mild cognitive disfunction or mild dementia. We will include patients with mild cognitive impairment or mild dementia (a Clinical dementia rating global score of 0.5 or 1.0) who are aged ≥ 40 years or, <90 years. All participants will be randomly assigned in a 1:1 ratio to either receive taxifolin 100mg/day or matching placebo daily for the first 12 weeks. This treatment will be followed by a 6-week washout period, then a second 12-week treatment period with the alternative therapy. Patients will be given 100 mg taxifolin capsules orally once a day or will be given placebo capsules orally once a day. The primary objective is whether taxifolin improves cognitive impairment, evaluated by Montreal Cognitive Assessment. We will recruit 60 patients in total. Conclusions The T-COG trial may provide valuable insights into new therapeutic approaches because taxifolin has multitarget neuroprotection that could potentially improve cognitive function, along with highly safe profile, and inexpensive costs.
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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 | 0.002 | 0.001 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| Bibliometrics | 0.001 | 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".