The PRagmatic EValuation of evENTs And Benefits of Lipid‐lowering in oldEr adults (PREVENTABLE) trial: Study design and procedures for cognitive assessment and adjudication
Bibliographic record
Abstract
Abstract Background No existing therapies for Alzheimer’s disease and related dementias fundamentally alter the trajectory of the disease. While observational data suggests statins may reduce cognitive and functional decline in older adults, randomized evidence is lacking. Method The PRagmatic EValuation of evENTs And Benefits of Lipid‐lowering in oldEr adults (PREVENTABLE) trial is funded by the National Institute on Aging, National Heart, Lung, and Blood Institute, and supported by the Alzheimer’s Association. The trial will test the primary hypothesis that randomization to atorvastatin 40 mg versus placebo results in superior survival free of incident dementia or persistent physical disability over 5 years. The development of mild cognitive impairment (MCI) is a secondary endpoint. The target sample size is 20,000 participants ≥75 years without dementia recruited from 90 sites across the US from the National Patient‐Centered Clinical Research Network and the Veterans Affairs system. The trial will use a pragmatic, standardized telephone‐based cognitive battery, centrally administered annually, which includes a cognitive screener, the Telephone Interview for Cognitive Status‐modified (TICSm). Based on TICSm scoring, an extended phone cognitive battery will be performed that includes measures of attention/executive function, verbal memory, language, and mood. In addition, the Functional Activities Questionnaire will be administered to a trusted contact. A telephone assessment of physical and functional status will also be administered annually. Cognitive and functional data will be adjudicated by a panel of experts, blinded to treatment assignment, to determine the occurrence of MCI (and subtype) or probable dementia. Result PREVENTABLE will utilize pragmatic data sources (electronic health records and administrative claims) to obtain relevant medical data; however, these mechanisms are unreliable at identifying incident dementia and MCI. The pandemic required modification of cognitive testing, embracing a purely telephonic approach at baseline, which will nonetheless permit cognitive adjudication of participants. Recruitment will be ongoing through April 2023 with results available in 2026. Conclusion PREVENTABLE represents the largest randomized pragmatic trial examining cognitive outcomes associated with statin use in older adults. Launching during the pandemic required adaptation to remote assessment, which will facilitate progress towards efficient and novel methods for pragmatic clinical trials aimed at preventing dementia.
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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 | 0.024 | 0.030 |
| Meta-epidemiology (narrow) | 0.004 | 0.001 |
| Meta-epidemiology (broad) | 0.007 | 0.005 |
| Bibliometrics | 0.001 | 0.002 |
| Science and technology studies | 0.001 | 0.002 |
| Scholarly communication | 0.002 | 0.002 |
| Open science | 0.002 | 0.002 |
| Research integrity | 0.004 | 0.003 |
| Insufficient payload (model declined to judge) | 0.015 | 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".