• J. Neurol. Neurosurg. Psychiatr. · Sep 2016

    Randomized Controlled Trial Multicenter Study

    ADCOMS: a composite clinical outcome for prodromal Alzheimer's disease trials.

    • Jinping Wang, Veronika Logovinsky, Suzanne B Hendrix, Stephanie H Stanworth, Carlos Perdomo, Lu Xu, Shobha Dhadda, Ira Do, Martin Rabe, Johan Luthman, Jeffrey Cummings, and Andrew Satlin.
    • Department of Neuroscience and General Medicine, Eisai Inc., Woodcliff Lake, New York, USA.
    • J. Neurol. Neurosurg. Psychiatr. 2016 Sep 1; 87 (9): 993-9.

    BackgroundDevelopment of new therapies for Alzheimer's disease (AD) is increasingly focused on more mildly affected populations, and requires new assessment and outcome strategies. Patients in early stages of AD have mild cognitive decline and no, or limited, functional impairment. To respond to these assessment challenges, we developed a measurement approach based on established scale items that exhibited change in previous amnestic Mild Cognitive Impairment (aMCI) trials.MethodsPartial least squares regression with a longitudinal clinical decline model identified items from commonly used clinical scales with the highest combined sensitivity to change over time in aMCI and weighted these items according to their relative contribution to detecting clinical progression in patients' early stages of AD. The resultant AD Composite Score (ADCOMS) was assessed for its ability to detect treatment effect in aMCI/prodromal AD (pAD) clinical trial populations.ResultsADCOMS consists of 4 Alzheimer's Disease Assessment Scale-cognitive subscale items, 2 Mini-Mental State Examination items, and all 6 Clinical Dementia Rating-Sum of Boxes items. ADCOMS demonstrated improved sensitivity to clinical decline over individual scales in pAD, aMCI and in mild AD dementia. ADCOMS also detected treatment effects associated with the use of cholinesterase inhibitors in these populations. Improved sensitivity predicts smaller sample size requirements when ADCOMS is used in early AD trials.ConclusionsADCOMS is proposed as new standard outcome for pAD and mild AD dementia trials, and is progressing in a CAMD-sponsored qualification process for use in registration trials of pAD.Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

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