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Publication Detail
Hippocampal Neuroimaging-Informed Clinical Trial Enrichment Tool for Amnestic Mild Cognitive Impairment Using Open Data
  • Publication Type:
    Journal article
  • Publication Sub Type:
    Journal Article
  • Authors:
    Conrado DJ, Burton J, Hill D, Willis B, Sinha V, Stone J, Coello N, Wang W, Chen D, Nicholas T, Gold M, Hartley E, Kern VD, Romero K
  • Publication date:
  • Pagination:
    903, 914
  • Journal:
    Clinical Pharmacology and Therapeutics
  • Volume:
  • Issue:
  • Status:
  • Print ISSN:
Our goal was to assess the enrichment utility of hippocampal volume (HV) as an enrichment biomarker in amnestic mild cognitive impairment (aMCI) clinical trials, and, hence, develop an HV neuroimaging-informed clinical trial enrichment tool. Modeling of integrated longitudinal patient-level data came from open-access natural history studies in patients diagnosed with aMCI—the Alzheimer’s Disease Neuroimaging Initiative (ADNI)-1 and ADNI-2—and indicated that a decrease of 1 cm3 with respect to the analysis dataset median baseline intracranial volume-adjusted HV (ICV-HV; ~ 5 cm3) is associated with > 50% increase in disease progression rate as measured by the Clinical Dementia Rating Scale–Sum of Boxes. Clinical trial simulations showed that the inclusion of aMCI subjects with baseline ICV-HV below the 84th or 50th percentile allowed an approximate reduction in trial size of at least 26% and 55%, respectively. This clinical trial enrichment tool can help design more efficient and informative clinical trials.
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