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Background: Clinical outcome assessments (COAs) that measure functional capacities are key tools to evaluate efficacy in Alzheimer's disease (AD) clinical trials. The Alzheimer's Disease Cooperative Study Activities of Daily Living (ADCS-ADL) scale is frequently used to assess changes in both basic and instrumental activities of daily living, but there is no clear consensus on what magnitude of change on this scale may be considered clinically meaningful. To address this question, we conducted anchor-based analyses (as recommended by the FDA) to explore meaningful within-patient/participant change thresholds on the ADCS-ADL.
View Article and Find Full Text PDFDrug Development.
Alzheimers Dement
December 2024
Critical Path for Alzheimer's Disease (CPAD) Consortium, Critical Path institute, Tucson, AZ, USA.
Background: To help improve the Alzheimer's disease (AD) therapeutics research and development process, the Critical Path for Alzheimer's Disease (CPAD) Consortium at the Critical Path Institute (C-Path) provides a neutral framework for the drug development industry, regulatory agencies, academia, and patient advocacy organizations to collaborate. CPAD's extensive track record of developing regulatory-grade quantitative drug development tools motivates sponsors to share patient-level data and neuroimages from clinical trials. CPAD leverages these data and uses C-Path's core competencies in data management and standardization, quantitative modeling, and regulatory science to develop tools that help de-risk decision making in AD drug development.
View Article and Find Full Text PDFDementia Care Research and Psychosocial Factors.
Alzheimers Dement
December 2024
University College London, London, United Kingdom.
Background: The progressive nature of dementia and the complex needs means that people living with dementia require tailored approaches to address their changing care needs over time. These include physical multimorbidity, psychological, behavioural, and cognitive symptoms and possible risks arising from these and helping family caregivers. However, provision of these interventions is highly variable between and within countries, partly due to uncertainty about their efficacy and scarce resources.
View Article and Find Full Text PDFDementia Care Research and Psychosocial Factors.
Alzheimers Dement
December 2024
Newcastle University, Newcastle, Newcastle Upon Tyne, United Kingdom.
Background: HIV-associated neurocognitive disorders (HAND) are prevalent complications of ageing with treated HIV, disproportionally affecting sub-Saharan Africa. Causal HAND treatments are lacking worldwide; therefore, reversible factors are important to explore. Sleep duration and quality are frequently associated with risk of cognitive impairments.
View Article and Find Full Text PDFDementia Care Research and Psychosocial Factors.
Alzheimers Dement
December 2024
Centre for Healthy Brain Ageing (CHeBA), University of New South Wales, UNSW Sydney, NSW, Australia.
Background: The effects of the COVID-19 pandemic extend beyond the viral impact and include social and psychological effects of the ensuing lockdowns and restrictions. Australia's lengthy lockdowns present an opportunity to study changes in the physical and mental wellbeing of older adults resulting from extended social isolation, a known risk factor for dementia, in the absence of high infection or mortality rates.
Method: Sydney Memory and Ageing Study, Sydney Centenarian Study, and CogSCAN study participants were mailed questionnaires about in-person and remote social contact and access to resources during the 2020 Sydney lockdown.
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