P3‐423: Efficacy of the 13.3 mg/24 h rivastigmine patch on instrumental activities of daily living in the OPtimising Transdermal Exelon In Mild‐to‐moderate Alzheimer's disease (OPTIMA) study: Prospective subgroup analysis by disease severity and time‐to‐meet decline
Bibliographic record
Abstract
OPTIMA, a 48-week randomized, double-blind (DB) study, compared the efficacy and safety of 13.3 and 9.5 mg/24 h rivastigmine patches in patients with AD meeting functional and cognitive decline criteria during an initial open-label (IOL) phase with 9.5 mg/24 h patch. The current analysis investigated the efficacy of 13.3 mg/24 h patch on the autonomy in instrumental activities of daily living (IADL) in patients by disease severity and time-to-meet decline criteria. Patients receiving rivastigmine patch 9.5 mg/24 h, were assessed at Weeks 24, 36 and 48 of the IOL phase for functional (investigators' judgement) and cognitive decline (≥2-point decrease in Mini-Mental State Examination [MMSE] score from previous visit OR ≥3-point decrease from baseline). Decliners entered the randomized DB phase (9.5 or 13.3 mg/24 h). Co-primary outcomes included change from DB-baseline at Week 48 on the AD Cooperative Study (ADCS)-IADL scale. Prospective subgroup analyses were efficacy on ADCS-IADL by: disease severity at DB-baseline (moderate [MMSE ≥10 ≤ 18] versus moderate-to-severe [MMSE ≥3 ≤ 18]); and time-to-meet decline criteria (≤ 36 versus >36 weeks). The mean DB-baseline ADCS-IADL score was higher with 13.3 mg/24 h, compared with 9.5 mg/24 h patch, for patients with moderate (26.7 and 24.5, respectively) or moderate-to-severe disease (25.3 and 22.8, respectively). At all time points, regardless of disease severity, slower decline in ADCS-IADL score was observed with 13.3 versus 9.5 mg/24 h patch. The mean DB-baseline ADCS-IADL score was higher with 13.3 mg/24 h, compared with 9.5 mg/24 h patch, for patients meeting decline criteria ≤ 36 weeks (27.1 and 24.5, respectively), but comparable for patients meeting decline criteria >36 weeks. Regardless of time-to-meet decline criteria, decline in ADCS-IADL score was less with 13.3 mg/24 h patch during Weeks 16 to 48.The superiority of the 13.3 mg/24 h patch compared with the 9.5 mg/24 h patch was confirmed by statistical comparisons adjusted for the corresponding baseline value for the different subgroup analyses. High-dose (13.3 mg/24 h) rivastigmine patch demonstrates superior efficacy on functional outcomes and provides additional benefits to patients with AD, compared with 9.5 mg/24 h patch, regardless of their disease severity or time-to-meet decline criteria.
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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 | 0.001 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.003 | 0.003 |
| 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 | 0.001 | 0.002 |
| Insufficient payload (model declined to judge) | 0.003 | 0.001 |
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".