Promoting diversity in clinical trials: insights from planning the ALUMNI AD study in historically underrepresented US populations with early symptomatic Alzheimer's disease.

Unlabelled: Clinical trial participation across disease areas, including Alzheimer's disease (AD), has been biased towards White participants of European ancestry. To support clinical decision-making across diverse populations, we must recognize and address barriers to trial participation. To inform the design of ALUMNI AD, a trial focused on historically underrepresented AD populations, we held advice-seeking fora with key stakeholders to understand barriers and identify potential solutions to maximize trial participation of underrepresented racial and ethnic groups in the US.

Trends in Healthcare Resource Use Preceding Diagnosis of Alzheimer's Disease Dementia.

Introduction: An Alzheimer's disease (AD) dementia diagnosis is often preceded by an extended period of cognitive decline. Few studies have examined healthcare resource use (HRU) during an extended period before AD dementia diagnosis.

Methods: In a historical claims-based cohort study, propensity score-matched cohorts of patients with and without AD dementia were observed for a 5-year prediagnosis period and a 1-year postdiagnosis period.

Meaningful benefits: a framework to assess disease-modifying therapies in preclinical and early Alzheimer's disease.

Background: The need for preventive therapies that interrupt the progression of Alzheimer's disease (AD) before the onset of symptoms or when symptoms are emerging is urgent and has spurred the ongoing development of disease-modifying therapies (DMTs) in preclinical and early AD (mild cognitive impairment [MCI] to mild dementia). Assessing the meaningfulness of what are likely small initial treatment effects in these earlier stages of the AD patho-clinical disease continuum is a major challenge and warrants further consideration. BODY: To accommodate a shift towards earlier intervention in AD, we propose meaningful benefits as a new umbrella concept that encapsulates the spectrum of potentially desirable outcomes that may be demonstrated in clinical trials and other studies across the AD continuum, with an emphasis on preclinical AD and early AD (i.