P3‐026: Trial of S‐Equol in Alzheimer’s Disease (SEAD)
Bibliographic record
Abstract
Mitochondrial dysfunction has been observed in Alzheimer’s disease (AD) patients. Specifically, cytochrome oxidase (COX, a mitochondrial electron transport chain enzyme) activity is reduced in both brain and platelet mitochondria from AD patients. S-equol is an estrogen receptor beta (ER-beta) agonist. ERbeta are localized within mitochondria, and activation stimulates mitochondrial function and mitochondrial biogenesis. Based on these observations we hypothesized S-equol may benefit AD subjects. 15 female AD participants (CDR 0.5 or 1) were enrolled into this 6-week, single-blind trial. The trial was designed to assess the primary outcome of platelet COX activity at baseline, in response to S-equol, and after a washout period. Participants were treated with twice a day placebo for two weeks, followed by 10mg twice a day S-equol for two weeks followed by a 2 week washout period. Phlebotomy, vitals, safety assessments, and a brief cognitive assessment (Montreal Cognitive Assessment exam (MoCA)) were completed at baseline, 2 weeks, 4 weeks, and 6 weeks. 15 participants were enrolled and 14 have completed the study. One subject dropped out prior to initiating the study due to non-study related reasons. In order to be considered a “responder” (i.e. increasing COX activity in response to treatment) the individual change (slope) between visits 2 and 3 had to be greater than the change (slope) between visits 3 and 4. When normalized to citrate synthase (CS) activity and protein concentration, 10 of the participants were considered responders, while 4 were considered non-responders. Of the 4 non-responders, one subject did show an increase in COX activity (normalized to protein and CS), but the visit 3 to 4 slope was greater than the visit 2 to 3 slope. S-equol was well-tolerated by and appeared safe in these AD participants. The study currently plans to enroll at least one additional subject, and upon completion of the study all endpoints will be analyzed. Our data suggest S-equol may increase platelet COX activity, warranting further testing in AD participants.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.001 | 0.000 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.002 | 0.001 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.000 |
| Research integrity | 0.002 | 0.002 |
| Insufficient payload (model declined to judge) | 0.009 | 0.002 |
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 source (direct Gemma or distilled Codex), 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".