Novel drug candidates targeting Alzheimer’s disease: ethical challenges with identifying the relevant patient population

Abstract

Intensive research is carried out to develop a disease-modifying drug for Alzheimer’s disease (AD). The development of drug candidates that reduce Aß or tau in the brain seems particularly promising. However, these drugs target people at risk for AD, who must be identified before they have any, or only moderate, symptoms associated with the disease. There are different strategies that may be used to identify these individuals (eg, population screening, cascade screening, etc). Each of these strategies raises different ethical challenges. In this paper, we analyse these challenges in relation to the risk stratification for AD necessary for using these drugs. We conclude that the new drugs must generate large health benefits for people at risk of developing AD to justify the ethical costs associated with current risk stratification methods, benefits much larger than current drug candidates have. This conclusion raises a new set of ethical questions that should be further discussed.

People get ready! A new generation of Alzheimer's therapies may require new ways to deliver and pay for healthcare

“…Patients in the early and milder disease stages may benefit the most in terms of outcomes; however, limiting treatment eligibility to this group challenges the traditional ethical principles of prioritizing patients with the greatest needs. Moreover, screening and early diagnostics increase the risk of treating ‘false positives’, which could cause unjustified anxiety, treatment burden and side effects in people who would never progress to clinical AD [58]. In this context, improved primary care capacity for assessments and generation of evidence is needed so that patients are given the opportunity of informed decisions.…”

Selecting the target population for new Alzheimer drugs: challenges and expectations

“…approach this question by addressing the benefits, harms and ethical issues encountered when using different modes of screening for 'preclinical' or early symptomatic Alzheimer disease (AD). 1 Their overall conclusion is clear-screening for high risk of developing AD dementia to select those who are eligible for treatment is ethically problematic, unless extremely effective treatment becomes available.…”

Commentary to ‘Novel drug candidates targeting Alzheimer’s disease: ethical challenges with identifying the relevant patient population’

“…Maria Eriksdotter 1,2 The article by Gustavsson et al 1 addresses the important question how to handle new medications with focus on drug candidates that reduce Aβ or tau in the brain, for individuals with Alzheimer's disease (AD), where the need for a diseasemodifying drug is enormous.…”