scholarly journals Integrating Biomarker Outcomes into Clinical Trials for Alzheimer’s Disease in Down Syndrome

Author(s):  
M.S. Rafii ◽  
S. Zaman ◽  
B.L. Handen

The NIH-funded Alzheimer’s Biomarker Consortium Down Syndrome (ABC-DS) and the European Horizon 21 Consortium are collecting critical new information on the natural history of Alzheimer’s Disease (AD) biomarkers in adults with Down syndrome (DS), a population genetically predisposed to developing AD. These studies are also providing key insights into which biomarkers best represent clinically meaningful outcomes that are most feasible in clinical trials. This paper considers how these data can be integrated in clinical trials for individuals with DS. The Alzheimer’s Clinical Trial Consortium - Down syndrome (ACTC-DS) is a platform that brings expert researchers from both networks together to conduct clinical trials for AD in DS across international sites while building on their expertise and experience.

2019 ◽  
Vol 15 ◽  
pp. P558-P560
Author(s):  
Juan Fortea ◽  
Eduard Vilaplana ◽  
Maria Carmona-Iragui ◽  
Bessy Benejam ◽  
Susana Fernandez ◽  
...  

1996 ◽  
Vol 8 (2) ◽  
pp. 277-290 ◽  
Author(s):  
Lon S. Schneider ◽  
Jason T. Olin

This article reviews the history of Clinical Global Impressions of Change (CGIC) instruments, their use and limitations in clinical trials of Alzheimer's disease, and the development of the National Institute on Aging's Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change Scale (ADCS-CGIC). Originally, CGICs were simple and unstructured instruments that asked a clinician to rate change over the duration of a clinical trial. The method, however, failed to consistently detect treatment effects, leading to the development of more structured and subsequently validated approaches, such as the Clinician Interview-Based Impression Scale (CIBI) and the ADCS-CGIC. Both are currently used in clinical trials. The implications and importance of choosing an appropriate global rating are discussed.


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