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http://dx.doi.org/10.1056/NEJM200001133420205 | DOI Listing |
Alzheimers Dement
December 2024
EQT Life Sciences Partners, Amsterdam, 1071 DV Amsterdam, Netherlands.
Background: Alzheimer's disease (AD) trials report a high screening failure rate (potentially eligible trial candidates who do not meet inclusion/exclusion criteria during screening) due to multiple factors including stringent eligibility criteria. Here, we report the main reasons for screening failure in the 12-week screening phase of the ongoing evoke (NCT04777396) and evoke+ (NCT04777409) trials of semaglutide in early AD.
Method: Key inclusion criteria were age 55-85 years; mild cognitive impairment due to AD (Clinical Dementia Rating [CDR] global score of 0.
Alzheimers Dement
December 2024
Xuanwu Hospital, Capital Medical University, Beijing, Beijing, China.
Background: Effective early intervention of mild cognitive impairment (MCI) is the key for preventing dementia. However, there is currently no drug for MCI. As a multi-targeted neuroprotective agent, butylphthalide has been demonstrated to repair cognition in patients with vascular cognitive impairment, and has the potential to treat MCI due to Alzheimer's disease (AD).
View Article and Find Full Text PDFAlzheimers Dement
December 2024
STEM Neurology & Neuropsychological0 Research Group Egypt (SNRGE), Port Said, Port Said, Egypt.
Background: Donepezil, an acetylcholinesterase inhibitor (AChEI), is an FDA-approved drug to treat these neurodegenerative diseases, e.g., Alzheimer's Disease (AD) and Mild Cognitive Impairment (MCI).
View Article and Find Full Text PDFRecent breakthrough findings in clinical trials on amyloid-lowering therapies have led to the approval of these drugs for the treatment of amyloid- positive elderly individuals who show symptoms of mild cognitive impairment and mild dementia. The next frontier is the testing the efficacy of treatments for secondary prevention of AD dementia. Phase III trials in asymptomatic AD are already under way, raising a host of novel questions on the sequelae of trial participation such as the emotional and social repercussions of biomarker disclosure, understanding the risk of side effects and eventually weighing the risk-benefit ratio of amyloid-lowering treatment.
View Article and Find Full Text PDFAlzheimers 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.
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