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.

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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

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article

Pragmatic trial design enhances diversity and retention among research participants with Lewy body diseases

Carolyn Paiz, Leila Saadatpour, Okeanis Vaou, Pablo Coss et al.
1 citations
npj Dementia
Ethics in Clinical Research
41.85
article

Pragmatic trial design enhances diversity and retention among research participants with Lewy body diseases

Carolyn Paiz, Leila Saadatpour, Okeanis Vaou, Pablo Coss, Chen Pin Wang, Diana Solis, Jessica Grimaldo, Sarah Horn, Sudha Seshadri, Sarah Erskine, Nghi Tran
article en
1 citations

Abstract

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.

npj DementiaVol. 2(1)
The University of Texas at San Antonio Health Science Center (US), Institute for Neurodegenerative Disorders (US)
Alzheimer's Association, National Institute on Aging
Openalex Percentile: Top 1%
Ethics in Clinical Research
41.85
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