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Drug Development.
Alzheimers Dement
December 2024
Karolinska Institute, Stockholm, Södermanland and Uppland, Sweden.
Background: Novel anti-amyloid therapies (AAT) for Alzheimer's Disease (AD) have recently been approved in the United States, Japan and China, and are under regulatory review in Europe. Questions remain regarding the long-term effectiveness and value of these drugs when used in routine clinical practice. Data from follow-up studies will be important to inform their optimal use, including criteria for treatment initiation, monitoring strategies, stopping rules, pricing and reimbursement considerations.
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Alzheimers Dement
December 2024
Center for Health + Technology, University of Rochester Medical Center, Rochester, NY, USA.
Background: In preparation for therapeutic trails involving patients with Alzheimer's disease (AD) and mild cognitive impairment (MCI), there is a need for valid, disease-specific caregiver-reported outcome (CRO) measures capable of tracking symptomatic burden in response to therapy over time. CROs are useful tools in clinical trials for individuals with AD, MCI, and dementia who are unable to self-report. In addition, CROs are accepted by the United States Food and Drug Administration to support regulatory claims.
View Article and Find Full Text PDFBackground: 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
Amsterdam Neuroscience, Vrije Universiteit Amsterdam, Amsterdam UMC, Amsterdam, Netherlands.
Background: The first disease-modifying treatments (DMTs) for Alzheimer's disease (AD) have been approved in the USA, marking profound changes in AD-diagnosis and treatment. This will bring new challenges in terms of clinician-patient communication. We aimed to collect the perspectives of memory clinic professionals regarding the most important topics to address and what (tools) would support professionals and their patients and care partners to engage in a meaningful conversation on whether (or not) to initiate treatment.
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Alzheimers Dement
December 2024
Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA.
Background: Anti-amyloid immunotherapies modestly slow disease progression in early symptomatic AD; addition of other therapeutic modalities may be necessary to achieve larger treatment effects. Therapies that directly target tau can potentially produce substantial clinical benefit because the accumulation of insoluble tau protein is strongly correlated with the progression of AD. Which tau therapies are likely to be efficacious, whether or not to combine them with anti-amyloid therapies, and which individuals are most likely to benefit are important unresolved questions that would require multiple parallel design trials to answer.
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