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

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

Alzheimers Dement. 2023 Feb 25. doi: 10.1002/alz.12995. Online ahead of print.


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.

PMID:36840622 | DOI:10.1002/alz.12995


Jorge J Llibre-Guerra
Anika Heavener
Sonia Maria Dozzi Brucki
Juan Pablo Díaz Marante
Maritza Pintado-Caipa
Yaohua Chen
María Isabel Behrens
Angela Hardi
Arianna Admirall-Sanchez
Rufus Akinyemi
Suvarna Alladi
Karen A Dorsman
Ana M Rodriguez-Salgado
Joel Solorzano
Ganesh M Babulal
Diversity and Disparity Professional Interest Area Increasing Sustained Diversity in Clinical Trials Working Group