P4‐225: A confirmatory phase 3 randomized, double‐blind, placebo‐controlled study of the safety and effectiveness of immune globulin intravenous (Human), 10% solution (GAMMAGARD LIQUID/KIOVIG) for the treatment of mild to moderate Alzheimer's disease
Bibliographic record
Abstract
Intravenous immunoglobulin (IVIg) has demonstrated promising results in the treatment of mild to moderate Alzheimer's disease (AD) in Phase 1 and Phase 2 trials. When compared to placebo, subjects treated with IVIg demonstrated improved cognitive performance, better global functioning, and less brain atrophy. In addition, IVIg use in clinical practice has been shown in retrospective analyses to be associated with a lower incidence of AD and related disorders. At present, a double-bind, placebo-controlled, parallel-group Phase 3 trial of gammagard liquid/kiovig (GAP study) in subjects with mild to moderate AD is ongoing in the United States and Canada. A confirmatory Phase 3 trial of gammagard liquid/kiovig in mild to moderate AD is planned to be initiated globally in 2011. Approximately 400 subjects will be randomized to receive either one of the 2 active dose arms (0.2 g/kg body weight [BW] or 0.4 g/kg BW) or placebo at matching volume every 2 weeks for 18 months. Primary endpoints will include ADAS-Cog and ADCS-ADL with secondary endpoints ADCS-CGIC, NPI, and volumetric MRI. Exploratory endpoints will include quality of life and pharmacoeconomic measures as well as time to skilled nursing facility placement. In addition, amyloid imaging will be studied in a subset of subjects, depending on the availability of the imaging agent. Based on results of the ongoing Phase 3 GAP study of IVIg, sample size and study duration adjustments may be made during the course of this confirmatory study accounting for the treatment effect size observed in the GAP study. Early Phase 1 and 2 studies have demonstrated that human immunoglobulin may have potential in the treatment of mild to moderate AD. However, these preliminary findings in small groups of subjects will need to be confirmed in large-scale, multi-center Phase 3 studies. One study with Gammagard Liquid/Kiovig is currently ongoing and a second is planned to begin in 2011.
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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) | 0.003 | 0.001 |
| Meta-epidemiology (broad) | 0.003 | 0.002 |
| Bibliometrics | 0.001 | 0.000 |
| Science and technology studies | 0.001 | 0.002 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.002 | 0.000 |
| Research integrity | 0.003 | 0.004 |
| Insufficient payload (model declined to judge) | 0.010 | 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".