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. 2023 Jul;19(7):3210-3221.
doi: 10.1002/alz.12995. Epub 2023 Feb 25.

A call for clinical trial globalization in Alzheimer's disease and related dementia

Jorge J Llibre-Guerra  1   2   3 , Anika Heavener  4 , Sonia Maria Dozzi Brucki  5 , Juan Pablo Díaz Marante  6 , Maritza Pintado-Caipa  7 , Yaohua Chen  8 , María Isabel Behrens  9 , Angela Hardi  10 , Arianna Admirall-Sanchez  11 , Rufus Akinyemi  12 , Suvarna Alladi  13 , Karen A Dorsman  14 , Ana M Rodriguez-Salgado  15 , Joel Solorzano  16 , Ganesh M Babulal  1   3   17   18 ; Diversity and Disparity Professional Interest Area Increasing Sustained Diversity in Clinical Trials Working Group
Affiliations

A call for clinical trial globalization in Alzheimer's disease and related dementia

Jorge J Llibre-Guerra et al. Alzheimers Dement. 2023 Jul.

Abstract

Background: The burden of Alzheimer's disease and related dementia (ADRD) is projected to disproportionally impact low-middle-income countries (LMICs). However, there is a systematic under-representation of LMICs in ADRD clinical trial platforms.

Methods: We aimed to determine the global distribution of ADRD clinical trials and identify existing barriers for conducting clinical trials in LMICs. Primary data sources to identify trial distribution in LMICs included ClinicalTrials.gov and the International Trials Registry Platform. An additional systematic review and expert consensus interviews were conducted to identify barriers for conducting clinical trials in LMICs.

Findings: Among 1237 disease-modifying therapies tested in ADRD clinical trials, only 11.6% have been or are conducted in emerging economies (upper-middle income [9.6%] and low-middle income [2.0%]). We identified several limitations for trial implementation including a lack of financial resources, low industry presence, regulatory obstacles, and operational barriers INTERPRETATION: Although LMICs bear the greatest burden of ADRD globally, substantial development of clinical trial platforms to address this inequity and health disparity is lacking.

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Conflict of interest statement

CONFLICT OF INTEREST STATEMENT

The authors report no disclosures relevant to this manuscript. Author disclosures are available in the supporting information.

Figures

FIGURE 1
FIGURE 1
PRISMA 2009 flow diagram for study selection. Panel A. Indicates sources and steps to determine global distribution of dementia clinical trials. Panel B. Indicates sources and steps to identifying barriers for conducting dementia clinical trials in LMICs.
FIGURE 2
FIGURE 2
Total number of registered clinical trial growth by economic development status and region, 2000–2021. Represent the absolute trial number without taking into consideration the number of countries represented in each category. North America included the United States and Canada (Mexico is included as part of Latin America).
FIGURE 3
FIGURE 3
Clinical trial density by region relative to the number of people with dementia, 2000–2021. Trial site year density was the number of registered clinical trial per years divided by regional dementia prevalence. Dementia estimates for each country were obtained from the 2019 Global Burden of Disease Study.
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References

    1. Norton S, Matthews FE, Barnes DE, Yaffe K, Brayne C. Potential for primary prevention of Alzheimer’s disease: an analysis of population-based data. Lancet Neurol. 2014;13:788–794. doi:10.1016/S1474-4422(14)70136-X - DOI - PubMed
    1. Wortmann M. Dementia: a global health priority - highlights from an ADI and World Health Organization report. Alzheimers Res Ther. 2012;4:1–3. doi:10.1186/alzrt143 - DOI - PMC - PubMed
    1. Cummings J, Lee G, Zhong K, Fonseca J, Taghva K. Alzheimer’s disease drug development pipeline: 2021. Alzheimers Dement (N Y). 2021;7:e12179. doi:10.1002/TRC2.12179 - DOI - PMC - PubMed
    1. Cummings J, Reiber C, Kumar P. The price of progress: funding and financing Alzheimer’s disease drug development. Alzheimers Dement (N Y). 2018;4:330–343. doi:10.1016/j.trci.2018.04.008 - DOI - PMC - PubMed
    1. Franzen S, Smith JE, van den Berg E, et al. Diversity in Alzheimer’s disease drug trials: the importance of eligibility criteria. Alzheimer’s Dement. 2021;18(4):810–823. doi:10.1002/ALZ.12433 - DOI - PMC - PubMed

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