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Preparing for preventive clinical trials: the Predict-HD study.

Jane S Paulsen1, Michael Hayden, Julie C Stout

  • 1Department of Psychiatry, University of Iowa, Iowa City 52242-1000, USA. jane-paulsen@uiowa.edu

Archives of Neurology
|June 14, 2006
PubMed
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Preventive trials for Huntington disease (HD) can use biological and clinical markers. This study examined prediagnostic measures in individuals carrying the HD gene expansion, finding significant declines associated with disease progression.

Area of Science:

  • Neurodegenerative disease research
  • Genetics and neurology
  • Clinical trial design

Background:

  • Optimal outcome measures for neurodegenerative disease prevention trials remain undefined.
  • Huntington disease (HD) is a progressive neurodegenerative disorder.

Purpose of the Study:

  • To identify potential clinical and biological markers for Huntington disease (HD) in prediagnostic individuals.
  • To analyze measures associated with disease progression in the largest cohort of gene expansion carriers.

Main Methods:

  • The Predict-HD study enrolled 505 at-risk individuals carrying the HD gene expansion.
  • Data collected included MRI-based basal ganglia volumes, cognitive tests, psychiatric distress scales, and motor assessments.
  • Estimated probability of diagnosis was calculated based on CAG repeat length.

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Main Results:

  • Progressive decline was observed in striatal volumes, cognitive function, and psychiatric ratings as disease indicators advanced.
  • Estimated probability of diagnosis correlated with motor abnormalities, rising from 15% to nearly 40%.

Conclusions:

  • Biological and refined clinical markers show promise as endpoints for HD prevention trials.
  • Longitudinal studies are essential to validate these potential markers for prediagnostic Huntington disease.