Diversity in Alzheimer's disease drug trials: The importance of eligibility criteria

Sanne Franzen; Jade Emily Smith; Esther van den Berg; Monica Rivera Mindt; Rozemarijn L. van Bruchem-Visser; Erin L. Abner; Lon S. Schneider; Niels D. Prins; Ganesh M. Babulal; Janne M. Papma

doi:10.1002/alz.12433

Diversity in Alzheimer's disease drug trials: The importance of eligibility criteria

Sanne Franzen^*, Jade Emily Smith, Esther van den Berg, Monica Rivera Mindt, Rozemarijn L. van Bruchem-Visser, Erin L. Abner, Lon S. Schneider, Niels D. Prins, Ganesh M. Babulal, Janne M. Papma

^*Corresponding author for this work

Research output: Contribution to journal › Review article › Academic › peer-review

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Abstract

Introduction To generalize safety and efficacy findings, it is essential that diverse populations are well represented in Alzheimer's disease (AD) drug trials. In this review, we aimed to investigate participant diversity in disease-modifying AD trials over time, and the frequencies of participant eligibility criteria. Methods A systematic review was performed using Medline, Embase, the Cochrane Library, and Clinicaltrials.gov, identifying 2247 records. Results In the 101 included AD trials, participants were predominantly White (median percentage: 94.7%, interquartile range: 81.0-96.7%); and this percentage showed no significant increase or decrease over time (2001-2019). Eligibility criteria such as exclusion of persons with psychiatric illness (78.2%), cardiovascular disease (71.3%) and cerebrovascular disease (68.3%), obligated caregiver attendance (80.2%), and specific Mini-Mental State Examination scores (90.1%; no significant increase/decrease over time) may have led to a disproportionate exclusion of ethnoracially diverse individuals. Discussion Ethnoracially diverse participants continue to be underrepresented in AD clinical trials. Several recommendations are provided to broaden eligibility criteria.

Original language	English
Pages (from-to)	810-823
Number of pages	14
Journal	Alzheimers & Dementia
Volume	18
Issue number	4
DOIs	https://doi.org/10.1002/alz.12433
Publication status	Published - Apr 2022

Bibliographical note

Funding Information:
SF and JMP report a grant from The Netherlands Organisation for Health Research and Development/Alzheimer Nederland (ZonMw Memorabel; grant number 733050834). JES reports a personal James B. Reynolds scholarship for foreign study. LSS reports a grant from NIH (P30 AG066530). GMB reports grants from NIH/NIA (R01AG068183, R01AG067428, A2021142S) and the BrightFocus Foundation (A2021142S). MRM is supported by grants from the NIA/NIH (R13 AG071313‐01, R01AG065110‐01A1, NIH/NIA 5U19AG024904‐14, NIH/NIA R01AG066471‐01A1), NIH/NIMH (U24MH100931‐03), NIH/NIA (5R24AG065163), National Science Foundation, the Genentech Health Equity 2020 Fund (G‐89294), and the Alzheimer's Association (AARGD‐16‐446038).

Funding Information:
The authors would like to thank Wichor Bramer from the Erasmus MC University Medical Center Rotterdam for his help in developing the search strategy and Jolien Franzen for her contribution to the results section. We also acknowledge the ABOARD consortium for supporting the work on diversity in primary and secondary prevention of Alzheimer’s disease in the Netherlands.

Publisher Copyright:
© 2021 The Authors. Alzheimer's & Dementia published by Wiley Periodicals LLC on behalf of Alzheimer's Association.

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Cite this

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title = "Diversity in Alzheimer's disease drug trials: The importance of eligibility criteria",

abstract = "Introduction To generalize safety and efficacy findings, it is essential that diverse populations are well represented in Alzheimer's disease (AD) drug trials. In this review, we aimed to investigate participant diversity in disease-modifying AD trials over time, and the frequencies of participant eligibility criteria. Methods A systematic review was performed using Medline, Embase, the Cochrane Library, and Clinicaltrials.gov, identifying 2247 records. Results In the 101 included AD trials, participants were predominantly White (median percentage: 94.7%, interquartile range: 81.0-96.7%); and this percentage showed no significant increase or decrease over time (2001-2019). Eligibility criteria such as exclusion of persons with psychiatric illness (78.2%), cardiovascular disease (71.3%) and cerebrovascular disease (68.3%), obligated caregiver attendance (80.2%), and specific Mini-Mental State Examination scores (90.1%; no significant increase/decrease over time) may have led to a disproportionate exclusion of ethnoracially diverse individuals. Discussion Ethnoracially diverse participants continue to be underrepresented in AD clinical trials. Several recommendations are provided to broaden eligibility criteria.",

author = "Sanne Franzen and Smith, {Jade Emily} and {van den Berg}, Esther and {Rivera Mindt}, Monica and {van Bruchem-Visser}, {Rozemarijn L.} and Abner, {Erin L.} and Schneider, {Lon S.} and Prins, {Niels D.} and Babulal, {Ganesh M.} and Papma, {Janne M.}",

note = "Funding Information: SF and JMP report a grant from The Netherlands Organisation for Health Research and Development/Alzheimer Nederland (ZonMw Memorabel; grant number 733050834). JES reports a personal James B. Reynolds scholarship for foreign study. LSS reports a grant from NIH (P30 AG066530). GMB reports grants from NIH/NIA (R01AG068183, R01AG067428, A2021142S) and the BrightFocus Foundation (A2021142S). MRM is supported by grants from the NIA/NIH (R13 AG071313‐01, R01AG065110‐01A1, NIH/NIA 5U19AG024904‐14, NIH/NIA R01AG066471‐01A1), NIH/NIMH (U24MH100931‐03), NIH/NIA (5R24AG065163), National Science Foundation, the Genentech Health Equity 2020 Fund (G‐89294), and the Alzheimer's Association (AARGD‐16‐446038). Funding Information: The authors would like to thank Wichor Bramer from the Erasmus MC University Medical Center Rotterdam for his help in developing the search strategy and Jolien Franzen for her contribution to the results section. We also acknowledge the ABOARD consortium for supporting the work on diversity in primary and secondary prevention of Alzheimer{\textquoteright}s disease in the Netherlands. Publisher Copyright: {\textcopyright} 2021 The Authors. Alzheimer's & Dementia published by Wiley Periodicals LLC on behalf of Alzheimer's Association.",

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AU - Franzen, Sanne

AU - Smith, Jade Emily

AU - van den Berg, Esther

AU - Rivera Mindt, Monica

AU - van Bruchem-Visser, Rozemarijn L.

AU - Abner, Erin L.

AU - Schneider, Lon S.

AU - Prins, Niels D.

AU - Babulal, Ganesh M.

AU - Papma, Janne M.

N1 - Funding Information: SF and JMP report a grant from The Netherlands Organisation for Health Research and Development/Alzheimer Nederland (ZonMw Memorabel; grant number 733050834). JES reports a personal James B. Reynolds scholarship for foreign study. LSS reports a grant from NIH (P30 AG066530). GMB reports grants from NIH/NIA (R01AG068183, R01AG067428, A2021142S) and the BrightFocus Foundation (A2021142S). MRM is supported by grants from the NIA/NIH (R13 AG071313‐01, R01AG065110‐01A1, NIH/NIA 5U19AG024904‐14, NIH/NIA R01AG066471‐01A1), NIH/NIMH (U24MH100931‐03), NIH/NIA (5R24AG065163), National Science Foundation, the Genentech Health Equity 2020 Fund (G‐89294), and the Alzheimer's Association (AARGD‐16‐446038). Funding Information: The authors would like to thank Wichor Bramer from the Erasmus MC University Medical Center Rotterdam for his help in developing the search strategy and Jolien Franzen for her contribution to the results section. We also acknowledge the ABOARD consortium for supporting the work on diversity in primary and secondary prevention of Alzheimer’s disease in the Netherlands. Publisher Copyright: © 2021 The Authors. Alzheimer's & Dementia published by Wiley Periodicals LLC on behalf of Alzheimer's Association.

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N2 - Introduction To generalize safety and efficacy findings, it is essential that diverse populations are well represented in Alzheimer's disease (AD) drug trials. In this review, we aimed to investigate participant diversity in disease-modifying AD trials over time, and the frequencies of participant eligibility criteria. Methods A systematic review was performed using Medline, Embase, the Cochrane Library, and Clinicaltrials.gov, identifying 2247 records. Results In the 101 included AD trials, participants were predominantly White (median percentage: 94.7%, interquartile range: 81.0-96.7%); and this percentage showed no significant increase or decrease over time (2001-2019). Eligibility criteria such as exclusion of persons with psychiatric illness (78.2%), cardiovascular disease (71.3%) and cerebrovascular disease (68.3%), obligated caregiver attendance (80.2%), and specific Mini-Mental State Examination scores (90.1%; no significant increase/decrease over time) may have led to a disproportionate exclusion of ethnoracially diverse individuals. Discussion Ethnoracially diverse participants continue to be underrepresented in AD clinical trials. Several recommendations are provided to broaden eligibility criteria.

AB - Introduction To generalize safety and efficacy findings, it is essential that diverse populations are well represented in Alzheimer's disease (AD) drug trials. In this review, we aimed to investigate participant diversity in disease-modifying AD trials over time, and the frequencies of participant eligibility criteria. Methods A systematic review was performed using Medline, Embase, the Cochrane Library, and Clinicaltrials.gov, identifying 2247 records. Results In the 101 included AD trials, participants were predominantly White (median percentage: 94.7%, interquartile range: 81.0-96.7%); and this percentage showed no significant increase or decrease over time (2001-2019). Eligibility criteria such as exclusion of persons with psychiatric illness (78.2%), cardiovascular disease (71.3%) and cerebrovascular disease (68.3%), obligated caregiver attendance (80.2%), and specific Mini-Mental State Examination scores (90.1%; no significant increase/decrease over time) may have led to a disproportionate exclusion of ethnoracially diverse individuals. Discussion Ethnoracially diverse participants continue to be underrepresented in AD clinical trials. Several recommendations are provided to broaden eligibility criteria.

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JO - Alzheimers & Dementia

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Diversity in Alzheimer's disease drug trials: The importance of eligibility criteria

Abstract

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