ADCOMS sensitivity versus baseline diagnosis and progression phenotypes

Author:

Evenden Dave1ORCID,Prosser Angus1ORCID,Michopoulou Sofia12ORCID,Kipps Christopher13ORCID,

Affiliation:

1. Clinical and Experimental Sciences University of Southampton Southampton UK

2. Imaging Physics University Hospital Southampton Southampton UK

3. Wessex Neurological Centre University Hospital Southampton Southampton UK

Abstract

AbstractBACKGROUNDThe Alzheimer's Disease COMposite Score (ADCOMS) is more sensitive in clinical trials than conventional measures when assessing pre‐dementia. This study compares ADCOMS trajectories using clustered progression characteristics to better understand different patterns of decline.METHODSPost‐baseline ADCOMS values were analyzed for sensitivity using mean‐to‐standard deviation ratio (MSDR), partitioned by baseline diagnosis, comparing with the original scales upon which ADCOMS is based. Because baseline diagnosis was not a particularly reliable predictor of progression, individuals were also grouped into similar ADCOMS progression trajectories using clustering methods and the MSDR compared for each progression group.RESULTSADCOMS demonstrated increased sensitivity for clinically important progression groups. ADCOMS did not show statistically significant sensitivity or clinical relevance for the less‐severe baseline diagnoses and marginal progression groups.CONCLUSIONSThis analysis complements and extends previous work validating the sensitivity of ADCOMS. The large data set permitted evaluation–in a novel approach–by the clustered progression group.

Publisher

Wiley

Reference32 articles.

1. Composite neurocognitive endpoints in Alzheimer's disease clinical trials: A commentary

2. Composite cognitive and functional measures for early stage Alzheimer's disease trials

3. US Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologics Evaluation and Research (CBER). Early Alzheimer's Disease: Developing Drugs for Treatment Guidance for Industry; February 2018; Revision 1. Accessed June 21 2022.https://www.fda.gov/regulatory‐information/search‐fda‐guidance‐documents/alzheimers‐disease‐developing‐drugs‐treatment‐guidance‐industy

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