MODERATO, a randomized, double-blind, placebo-controlled study to assess the effect of rasagiline on mild cognitive impairment in patients with Parkinson’s disease: An ongoing study (P3.027)
Bibliographic record
Abstract
Objectives: To determine the effect of 24 weeks of treatment with rasagiline 1 mg/day on cognitive abilities in Parkinson’s disease patients with mild cognitive impairment (PD-MCI) compared with placebo, as assessed by the Scales for Outcomes of Parkinson's Disease-Cognition (SCOPA-COG). Background: Although MCI is reported to affect up to a third of PD patients, surveys indicate that it is only rarely diagnosed or treated. Rasagiline is a selective irreversible MAO-B inhibitor indicated for the treatment of signs and symptoms of PD. Preliminary results from a small randomized, double-blind, placebo-controlled study suggest that rasagiline 1 mg/day may exert beneficial effects on attention and executive abilities in PD patients with MCI. Methods: MODERATO is an ongoing randomized, double-blind, placebo-controlled, study in patients (45-80 years) with PD-MCI (MDS Taskforce criteria) and a Montreal Cognitive Assessment (MoCA) rating scale score 20-25. Patients are randomized (1:1) to receive rasagiline 1 mg/day or placebo in addition to their current stable dopaminergic therapy. Baseline PD medications remain unchanged through the study. Primary endpoint is the mean change from baseline to Week 24 in SCOPA-COG summary score. Key secondary measures include: Unified Parkinson’s Disease Rating Scale (UPDRS) motor and activities of daily living (ADL) scores, MoCA scores and Functional Independence Index (FII). Results: Enrollment is now complete. We present here verified baseline data from the first 124 randomized patients. Baseline characteristics (mean): age 67.8 years, total UPDRS score 29.3, MoCA score 23.4, SCOPA-COG score 23.8 and FII score 28.7. Conclusion: The management of MCI represents a significant unmet need in PD. MODERATO is the largest trial to date to assess the efficacy of rasagiline 1 mg/day in a PD-MCI population. Study supported by Teva Pharmaceuticals
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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 | 0.002 | 0.001 |
| Meta-epidemiology (narrow) | 0.002 | 0.001 |
| Meta-epidemiology (broad) | 0.004 | 0.002 |
| Bibliometrics | 0.001 | 0.000 |
| Science and technology studies | 0.001 | 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) | 0.008 | 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".