We found a match
Your institution may have access to this item. Find your institution then sign in to continue.
- Title
Operationalizing selection criteria for clinical trials in Alzheimer's disease: Biomarker and clinical considerations.
- Authors
Petersen, Ronald C.; Graf, Ana; Brady, Chris; De Santi, Susan; Florian, Hana; Landen, Jaren; Pontecorvo, Mike; Randolph, Christopher; Sink, Kaycee M.; Carrillo, Maria C.; Weber, Christopher J.
- Abstract
Alzheimer's disease (AD) staging criteria lack standardized, empirical description. Well‐defined AD staging criteria are an important consideration in protocol design, influencing a more standardized inclusion/exclusion criteria and defining what constitutes meaningful differentiation among the stages. However, many trials are being designed on the basis of biomarker features and the two need to be coordinated. The Alzheimer's Association Research Roundtable (AARR) Spring 2021 meeting discussed the implementation of preclinical AD staging criteria, and provided recommendations for how they may best be incorporated into clinical trials research. Discussion also included what currently available tools for global clinical trials may best define populations in preclinical AD trials, and if are we able to differentiate preclinical from clinical stages of the disease. Well‐defined AD staging criteria are key to improving early detection, diagnostics, clinical trial enrollment, and identifying statistically significant clinical changes, and researchers discussed how emerging blood biomarkers may help with more efficient screening in preclinical stages.
- Subjects
ALZHEIMER'S disease; CLINICAL trials; BIOMARKERS; SPRING; MEDICAL research
- Publication
Alzheimer's & Dementia: Translational Research & Clinical Interventions, 2023, Vol 9, Issue 4, p1
- ISSN
2352-8737
- Publication type
Article
- DOI
10.1002/trc2.12434