Clinical Trial: Neurobiological Predictors of Huntington's Disease (PREDICT-HD)

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Observational

Official Title: Neurobiological Predictors of Huntington's Disease Trial

Brief Summary: The purpose of this trial is to study early brain and behavioral changes in people who have the gene expansion for Huntington's disease, but are currently healthy and have no symptoms.

Detailed Summary:

Huntington's Disease (HD) is an inherited disease that causes changes in a person's ability to control movements, thinking, and feelings. The intent of this study is to learn more about the beginning changes in thinking skills, emotional regulation, and brain structure and function as a person begins the transition from health to HD.

Preliminary studies indicate that people with HD may have marked decline before an actual diagnosis. This study will help reveal the earliest indicators of the disease and what factors influence the age at which a person carrying the gene develops the disease. It is necessary to get information on the early stages of HD in order to develop drugs that can slow or postpone the onset of HD. The investigators hope this study will provide essential information for future trials of experimental drugs for HD.

During this study, participants will undergo several detailed tests, including MRI scans of the brain, cognitive assessments, physical exams, bio specimen (blood, urine, cerebral spinal fluid) collection and neurological and psychiatric testing.


Sponsor: University of Iowa

Current Primary Outcome:

  • Refine the prediction of disease diagnosis (motor conversion) using longitudinal measures of plasma, imaging, cognitive performance, motor ratings, psychiatric and functional measures [ Time Frame: One year ]
    HD diagnosis will be better predicted by adding longitudinal change to the baseline measures of striatal and white matter volumes, tone-paced and speeded tapping score, tower moves, stroop interference and motor score.
  • Improve markers of disease progression that become abnormal prior to the clinical diagnosis and to characterize their natural history. [ Time Frame: One year ]

    Predictive models for HD diagnosis will be further improved (resulting in greater power and lower clinical trial sample size) by adding additional, sensitive measures to the PREDICT-HD exam (e.g., behavioral: companion frontal rating, cognitive: Maze test score, imaging: DTI fractional anisotropy, plasma marker: 8OHDG).

    Comparisons of change rates across time will suggest measures best suited to clinical trials by large effect sizes and low variability.

  • Establish the validity and reliability of disease measures identified in Outcomes 1 and 2. [ Time Frame: One year ]

    This will require that we continuously analyze recently collected data, remove items that are insensitive, and add new items to be tested throughout the course of the study. The power and sensitivity of future multi-site trials and studies depend on accurate measures of marker validity.

    HD diagn

    Original Primary Outcome:

    Current Secondary Outcome:

    Original Secondary Outcome:

    Information By: University of Iowa

    Dates:
    Date Received: January 8, 2003
    Date Started: August 2002
    Date Completion: August 2017
    Last Updated: October 27, 2016
    Last Verified: October 2016