Drug Development

Area of Science:

• Neurology
• Clinical Trials
• Health Disparities

Background:

• Alzheimer's disease (AD) prevalence differs across racial and ethnic groups.
• Phase III clinical trials are crucial for establishing the safety and efficacy of new AD therapies.
• Accurate demographic representation in trials is essential to reflect the population at risk.

Purpose of the Study:

• To assess the demographic representation of racial groups in Phase III anti-amyloid therapy trials for Alzheimer's disease.
• To compare trial participant demographics with US disease prevalence data.

Main Methods:

• Cross-sectional analysis of completed Phase III anti-amyloid monoclonal antibody trials for AD.
• Extraction of trial demographic data.
• Comparison of trial data with US disease prevalence to calculate Enrollment Incidence Ratios (EIR).

Main Results:

• 18 of 19 trials (19,613 patients) analyzed, focusing on anti-amyloid monoclonal antibodies.
• Caucasian individuals were overrepresented (EIR = 1.10), while Black (EIR = 0.10) and Hispanic (EIR = 0.66) individuals were significantly underrepresented.
• No significant change in the proportion of Asian, Black, or Hispanic participants over time.

Conclusions:

• Phase III anti-amyloid trials for AD have historically overrepresented Caucasian individuals and underrepresented Black and Hispanic individuals.
• The current evidence base for AD anti-amyloid therapies does not proportionally reflect the racial and ethnic demographics of the disease.
• Future trials must prioritize proactive recruitment from underrepresented groups to ensure treatment safety and efficacy across diverse populations.