Impacts of Informant Replacement in Industry‐Sponsored Alzheimer’s Disease Clinical Trials
Mikaela K Nishida, Michelle M Nuño, Joshua D Grill, Daniel L Gillen · 2025
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Description
Mikaela Nishida and three co-authors study what happens when a trial informant is replaced mid study in Alzheimer's trials in this 2025 paper. Participants enroll with a study partner who reports on daily function. Earlier academic trials showed that swapping that partner mid trial skews results. The team reanalyzed two industry trials of one drug, covering 2,642 participants. Seventy-two participants, about three percent, had at least one replacement. The outcome was a standard daily living score reported by the partner.
Visits after a swap swung more from visit to visit than visits with a steady partner. The average change did not shift, but its variability grew by a clear margin. Over seventy-six weeks, total change and its spread looked the same in both groups. The authors conclude that replacement adds noise rather than bias. Trial planners should still plan for it, since noise can mask drug effects.
Catalog record
| CREATOR | Mikaela K Nishida, Michelle M Nuño, Joshua D Grill, Daniel L Gillen |
|---|---|
| YEAR | 2025 |
| COLLECTION | PAPERS |
| FORMAT | TXT |
| FILE SIZE | 3 KB |
| VERSION | 1.0 |
| LICENSE | CC BY 4.0 |
| RIGHTS | CC BY |
| SOURCE | Europe PMC |