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

AI Article Synopsis

  • Alzheimer's disease and related dementia (ADRD) significantly affect low-middle-income countries (LMICs), but these regions are underrepresented in clinical trials for treatment.
  • A study analyzed the distribution of ADRD clinical trials globally and found that only 11.6% of trials for disease-modifying therapies occurred in emerging economies, with only 2.0% in low-middle-income nations.
  • Key barriers to conducting trials in LMICs include financial limitations, insufficient industry support, regulatory challenges, and operational issues, highlighting a significant health equity gap that needs to be addressed.

Article 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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Source
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC10450094PMC
http://dx.doi.org/10.1002/alz.12995DOI Listing

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