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Background: Selecting the optimal dose for clinical development is especially problematic for drugs directed at CNS-specific targets. For drugs with a novel mechanism of action, these problems are often greater. We describe Xanamem's clinical pharmacology, including the approach to dose selection and proof-of-concept studies.
View Article and Find Full Text PDFDrug Development.
Alzheimers Dement
December 2024
University of California San Francisco (UCSF), San Francisco, CA, USA; Northern California Institute for Research & Education (NCIRE), San Francisco, CA, USA; San Francisco Veterans Administration Medical Center (SFVAMC), San Francisco, CA, CA, USA.
The Alzheimer's Disease Neuroimaging Initiative (ADNI) has made many important contributions to the development of Alzheimer's Disease (AD) disease modifying treatments and diagnostic biomarkers. Since its funding in 2004 by the National Institutes of Aging, the goal of ADNI has been the validation of biomarkers for AD treatment trials. ADNI has enrolled over 2,400 participants in the USA and Canada for longitudinal clinical, cognitive, and biomarker studies.
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 PDFDementia Care Research and Psychosocial Factors.
Alzheimers Dement
December 2024
Acumen Pharmaceuticals, Charlottesville, VA, USA.
Background: Incorporation of the patient voice into drug development has been recognized as fundamental; recent legislation has addressed the importance of collecting patient experience data. Qualitative patient interviews conducted in tandem with clinical trials, often in later phases, are among the most common means of eliciting these data. To assess aspects of patient experience earlier in development, we conducted semi-structured qualitative interviews following participation in the phase 1 ACU-001 (INTERCEPT-AD) trial, a study evaluating the safety and tolerability of the Aβ oligomer-targeting monoclonal antibody ACU193, among a subset of participants with mild cognitive impairment (MCI) or mild Alzheimer's disease (AD) and their study partners.
View Article and Find Full Text PDFDementia Care Practice.
Alzheimers Dement
December 2024
University of Waterloo, Waterloo, ON, Canada.
Background: The Medication Review in Cognitive Impairment and Dementia (MedRevCiD) checklist is a new tool designed to assist health care professionals in optimizing medication use in individuals with Mild Cognitive Impairment (MCI) or dementia. It consists of 6 domains, each of which addresses a specific medication use issue such as medication management and adherence. The primary objective of this study was to compare the mean number of drug-related problems (DRPs) identified with MedRevCiD Checklist to the Medication Appropriateness Index (MAI) in older adults attending a primary care-based memory clinic.
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