Similar Publications

Drug Development.

Alzheimers Dement

December 2024

Novo Nordisk A/S, Søborg, 2860 Søborg, Denmark.

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.

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Drug Development.

Alzheimers Dement

December 2024

NA, Charlottesville, VA, USA.

Preclinical Alzheimer's prevention trials require a multi-year commitment from diverse, cognitively unimpaired individuals willing to receive biomarker results of confirmed Alzheimer's pathology and possible ApoE4 status. Participants learn new terms such as ARIA, edema and microhemorrhage and undergo numerous MRI scans for safety monitoring. They take quarterly composite Alzheimer's assessments that are anxiety-provoking and highlight weaknesses which may have been unrecognized in daily life.

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Drug Development.

Alzheimers Dement

December 2024

Axsome Therapeutics, New York, NY, USA.

Background: 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).

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Drug Development.

Alzheimers Dement

December 2024

Massachusetts General Hospital, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.

Preclinical Alzheimer's disease (AD) trials can involve multiple years of follow-up and burdensome procedures for older individuals. Optimizing the design and conduct of these trials requires input from participants and their families. Since 2020, the Alzheimer's Clinical Trials Consortium (ACTC) Research Participant Advisory Board has provided input on study attributes including: participant and study partner compensation, consent language, and result communication tools.

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Drug 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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