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Background: Phase 3 randomized clinical trials within Alzheimer's Disease (AD) typically last over 18 months. Post-baseline participants can use additional treatment for Alzheimer's disease, potentially impacting the cognitive ability as evaluated by the primary endpoint. Consequently, this could overestimate or underestimate the treatment effect, depending on the distribution of usage between treatment arms.
View Article and Find Full Text PDFBackground: Patients with Alzheimer's disease (AD) often experience burdensome neuropsychiatric symptoms, including agitation which occurs in both home and long-term care (LTC) facilities, and is associated with substantial increases in caregiver burden and LTC placements. AXS-05 (45-mg dextromethorphan/105-mg bupropion), a novel, oral NMDA receptor antagonist and sigma-1 receptor agonist, approved by the FDA for major depressive disorder, is being investigated for treatment of AD agitation (ADA). AXS-05 has been evaluated in 2 randomized, double-blind studies: Phase 2 ADVANCE-1 (NCT03226522); Phase 3 ACCORD (NCT04797715).
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.
View Article and Find Full Text PDFDrug Development.
Alzheimers Dement
December 2024
Tokyo Metropolitan Institute for Geriatrics and Gerontology, Tokyo, Japan.
In Japan, the regulatory authority approved the drug in September 2023, and on December 20, it became available for prescription country-wide under the health insurance system. However, there are strict patient, physician, and facility requirements for the prescription of Lecanemab, and various problems are anticipated in its future implementation and widespread use in society. Lecanemab is the first anti-Aβ antibody in Japan, and even dementia specialists do not have sufficient knowledge and experience in its introduction, evaluation of efficacy, and evaluation and handling of side effects.
View Article and Find Full Text PDFReal-world data on the uptake, effectiveness and safety of new diagnostics and disease-modifying (DMT) treatments for Alzheimer's Disease (AD) are imperative. This can be achieved through patient registries. A major challenge is how to embed registry data capture into routine clinical practice.
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