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

Jorge J. Llibre-Guerra, Department of Neurology, Washington University, School of Medicine, St. Louis, Missouri, USA.
Anika Heavener, Department of Global Health and Social Medicine, Harvard Medical School, St. Louis, Missouri, USA.
Sonia Maria Brucki, Cognitive and Behavioral Neurology Unit, Department of Neurology, University of Sao Paulo, São Paulo, Brazil.
Juan Pablo Marante, Department of Primary Care, Espirutu Santo, Brazil.
Maritza Pintado-Caipa, Instituto Peruano de Neurociencias, Lima, Peru.
Yaohua Chen, Department of Geriatrics, Lille Neurosciences & Cognition, University of Lille, Lille, France.
María Isabel Behrens, Departamento de Neurología y Neurocirugía, Hospital Clínico Universidad de Chile, Independencia, Santiago, Chile.
Angela Hardi, Becker Medical Library, Washington University School of Medicine, St. Louis, Missouri, USA.
Arianna Admirall-Sanchez, Centre of Public Health, Trinity College Dublin, Dublin, Ireland.
Rufus Akinyemi, Centre for Genomic and Precision Medicine, College of Medicine, University of Ibadan, Ibadan, Nigeria.
Suvarna Alladi, National Institute of Mental Health and Neuroscience, Bangalore, India.
Karen A. Dorsman, University of Texas Southwestern Medical Center, Dallas, Texas, USA.
Ana M. Rodriguez-Salgado, Global Brain Health Institute, San Francisco, California, USA.
Joel Solorzano, Department of Medicine, Hospital Antonio Luaces Iralola, Ciego de Avila, Cuba.
Ganesh M. Babulal, Department of Neurology, Washington University, School of Medicine, St. Louis, Missouri, USA.

Document Type

Journal Article

Publication Date

2-25-2023

Journal

Alzheimer's & dementia : the journal of the Alzheimer's Association

DOI

10.1002/alz.12995

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.

Department

Clinical Research and Leadership

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