OBJECTIVES : Family caregivers are intimately involved in the treatment of patients with Alzheimer’s disease (AD) and other dementias, providing long hours of assistance with essential daily activities. Caregivers experience a high level of strain, with physical, emotional, social, and financial impacts. Interventions that reduce strains of caregiving can augment caregivers’ quality of life and their capacity to provide high-quality care. This review examined how caregiver-reported outcomes (CgROs) were captured in clinical trials of pharmacologic therapies in AD and other dementias in the past decade.

METHODS : A targeted PubMed review was performed to identify CgRO data reported in publications of randomized clinical trials of pharmacologic therapies in AD and other dementias. Criteria for exclusion included: non-pharmacologic therapies and nutritional supplements, study designs other than interventional randomized clinical trials, and publications reporting on trial design. Results were limited to English-language publications from 2011-2020.

RESULTS : In >400 clinical trial publications screened in AD, Parkinson’s disease dementia, dementia with Lewy Bodies, and vascular dementia, 29 reported CgRO data. Donepezil was the most common intervention (n=8), followed by memantine (n=7). The most common CgRO instrument was the Zarit Burden Interview (n=15), followed by the Neuropsychiatric Inventory caregiver distress scale (n=7). CgROs mirrored clinical efficacy endpoints; in studies reporting cognitive function benefits or reduction in neuropsychiatric symptoms, caregiver burden and distress were generally decreased. Other outcomes reported included caregiving time commitments (n=2), caregiver depression (n=2), caregiver quality of life (n=2), and caregiver-reported treatment adherence (n=2).

CONCLUSIONS : CgRO evidence complements clinical efficacy measures in evaluating the potential value of pharmacologic therapies in AD and other dementias. Over the past decade, few clinical trial publications have reported outcomes related to caregiving strain and caregiver quality of life. There is an opportunity to recognize CgROs as a distinct form of information in medical product development and promote their collection with validated assessments.