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

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

Volume: 19

Issue: 7

Year of Publication: 2023

Affiliated Institutions:  Department of Neurology, Washington University, School of Medicine, St. Louis, Missouri, USA. Department of Global Health and Social Medicine, Harvard Medical School, St. Louis, Missouri, USA. Cognitive and Behavioral Neurology Unit, Department of Neurology, University of Sao Paulo, São Paulo, Brazil. Department of Primary Care, Espirutu Santo, Brazil. Instituto Peruano de Neurociencias, Lima, Peru. Department of Geriatrics, Lille Neurosciences & Cognition, University of Lille, Lille, France. Departamento de Neurología y Neurocirugía, Hospital Clínico Universidad de Chile, Independencia, Santiago, Chile. Becker Medical Library, Washington University School of Medicine, St. Louis, Missouri, USA. Centre of Public Health, Trinity College Dublin, Dublin, Ireland. Centre for Genomic and Precision Medicine, College of Medicine, University of Ibadan, Ibadan, Nigeria. National Institute of Mental Health and Neuroscience, Bangalore, India. University of Texas Southwestern Medical Center, Dallas, Texas, USA. Global Brain Health Institute, San Francisco, California, USA. Department of Medicine, Hospital Antonio Luaces Iralola, Ciego de Avila, Cuba.

Abstract summary 

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.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.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.

Authors & Co-authors:  Llibre-Guerra Jorge J JJ Heavener Anika A Brucki Sonia Maria Dozzi SMD Marante Juan Pablo Díaz JPD Pintado-Caipa Maritza M Chen Yaohua Y Behrens María Isabel MI Hardi Angela A Admirall-Sanchez Arianna A Akinyemi Rufus R Alladi Suvarna S Dorsman Karen A KA Rodriguez-Salgado Ana M AM Solorzano Joel J Babulal Ganesh M GM

Study Outcome 

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Statistics
Citations :  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
Authors :  16
Identifiers
Doi : 10.1002/alz.12995
SSN : 1552-5279
Study Population
Male,Female
Mesh Terms
Humans
Other Terms
Study Design
Cross Sectional Study
Study Approach
Systemic Review
Country of Study
Publication Country
United States