Aducanumab Approval and Alzheimer Disease Research

This set of flashcards covers key vocabulary related to the controversy surrounding the approval of aducanumab for Alzheimer disease, emphasizing issues of race, representation, and health equity.

Aducanumab

A medication recently approved by the FDA for treating Alzheimer disease, though its efficacy evidence was deemed inadequate.

FDA

The US Food and Drug Administration, which provided accelerated approval for aducanumab to treat Alzheimer's disease.

Efficacy

The ability of a medication to produce the desired beneficial effects.

Systemic Racism

Systematic and pervasive inequities rooted in societal norms and policies that adversely affect racial and ethnic groups.

ARIA

Amyloid-related imaging abnormalities, common adverse events attributed to aducanumab involving microhemorrhages and vasogenic edema.

Inclusion

The necessity of involving diverse populations in clinical trials to ensure research reflects the demographics affected by diseases.

APOE e4 allele

A genetic variant associated with a higher risk of Alzheimer disease, particularly prevalent among Black individuals.

Health Inequities

Disparities in health outcomes and access to healthcare experienced by marginalized groups.

Montreal Cognitive Assessment (MoCA)

A cognitive screening test that has been criticized for misclassifying cognitive impairment among Black individuals.

Medicare Coverage

Health insurance for people 65 and older in the U.S., which may face financial strain due to high costs of medications like aducanumab.

Equity in Neuroscience and Alzheimer Clinical Trials (ENACT) Act

Legislation aimed at improving diversity in representation within Alzheimer clinical trials.