Bibliographic record
Abstract
<b>JAMA</b> <b>Effect of Tarenflurbil on Cognitive Decline and Activities of Daily Living in Patients With Mild Alzheimer Disease: A Randomized Controlled Trial</b> Robert C. Green, MD, MPH; Lon S. Schneider, MD; David A. Amato, PhD; Andrew P. Beelen, MD; Gordon Wilcock, MD; Edward A. Swabb, MD, PhD; Kenton H. Zavitz, PhD; for the Tarenflurbil Phase 3 Study Group <h3>Context: </h3> Amyloid-β peptide (Aβ<sub>42</sub>) has been implicated in the pathogenesis of Alzheimer disease (AD). Tarenflurbil, a selective Aβ<sub>42</sub>-lowering agent, demonstrated encouraging results on cognitive and functional outcomes among mildly affected patients in an earlier phase 2 trial. <h3>Objective: </h3> To determine the efficacy, safety, and tolerability of tarenflurbil. <h3>Design, Setting, and Patients: </h3> A multicenter, randomized, double-blind, placebo-controlled trial enrolling patients with mild AD was conducted at 133 trial sites in the United States between February 21, 2005, and April 30, 2008. Concomitant treatment with cholinesterase inhibitors or memantine was permitted. <h3>Intervention: </h3> Tarenflurbil, 800 mg, or placebo, administered twice a day. <h3>Main Outcome Measures: </h3> Co-primary efficacy end points were the change from baseline to month 18 in total score on the subscale of the Alzheimer Disease Assessment Scale–Cognitive Subscale (ADAS-Cog, 80-point version) and Alzheimer Disease Cooperative Studies–activities of daily living (ADCS-ADL) scale. Additional prespecified slope analyses explored the possibility of disease modification. <h3>Results: </h3> Of the 1684 participants randomized, 1649 were included in the analysis, and 1046 completed the trial. Tarenflurbil had no beneficial effect on the co-primary outcomes (difference in change from baseline to month 18 vs placebo, based on least squares means: 0.1 for ADAS-Cog; 95% CI, −0.9 to 1.1;<i>P</i> = .86 and −0.5 for ADCS-ADL; 95% CI, −1.9 to 0.9;<i>P</i> = .48) using an intent-to-treat analysis. No significant differences occurred in the secondary outcomes. The ADAS-Cog score decreased by 7.1 points over 18 months. The tarenflurbil group had a small increase in frequency of dizziness, anemia, and infections. <h3>Conclusion: </h3> Tarenflurbil did not slow cognitive decline or the loss of activities of daily living in patients with mild AD. <h3>Trial Registration: </h3> clinicaltrials.gov Identifier:NCT00105547 <i>JAMA. 2009;302(23):2557-2564.</i>
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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) | 0.001 | 0.000 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.001 | 0.004 |
| 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".