Pragmatic trial design enhances diversity and retention among research participants with Lewy body diseases
An ongoing pragmatic, randomized, unblinded clinical trial compares pimavanserin and quetiapine for psychosis in Lewy body diseases over 6 months (<i>n</i> = 60). Relative to local explanatory clinical trials, retention is higher (93% vs 40%, <i>p</i> < 0.001) and Hispanic enrollment greater (38% vs 21%, <i>p</i> = 0.043), reflecting the clinic demographics. Embedding pragmatic trials within routine care can enhance retention and diversity, thereby improving representativeness and real-world applicability of clinical research. Registry: ClinicalTrials.gov, TRN: NCT05590637; Registration Date: 18 October 2022.
Authors
- Carolyn Paiz
- Leila Saadatpour (ORCID: https://orcid.org/0000-0002-3707-819X)
- Okeanis Vaou (ORCID: https://orcid.org/0000-0003-0453-3077)
- Pablo Coss
- Chen Pin Wang
- Diana Solis
- Jessica Grimaldo
- Sarah Horn
- Sudha Seshadri
- Sarah Erskine
- Nghi Tran
Institutions
- The University of Texas at San Antonio Health Science Center (US)
- Institute for Neurodegenerative Disorders (US)
Publication Details
- Journal
- npj Dementia
- Published
- 2026-02-02
- DOI
- https://doi.org/10.1038/s44400-026-00059-x
- Citations
- 1
- Primary Topic
- Ethics in Clinical Research
- Type
- article
- Field-Weighted Citation Impact
- 41.85
Funders
- Alzheimer's Association
- National Institute on Aging