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

This study is ongoing, but not recruiting participants.
ClinicalTrials.gov Identifier:
First Posted: January 9, 2003
Last Update Posted: October 28, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
Jane S. Paulsen, University of Iowa
January 8, 2003
January 9, 2003
October 28, 2016
August 2002
August 2017   (Final data collection date for primary outcome measure)
  • 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 diagnosis will be better predicted by UHDRS total motor score following new standardized reliability training and by the tapping task under modified more challenging, conditions. Psychiatric and functional ratings will be improved with item response analyses and dynamic piloting of item edits to establish the most psychometrically sound items for clinical trials.

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Complete list of historical versions of study NCT00051324 on ClinicalTrials.gov Archive Site
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  • Cerebral spinal fluid containing unique biomarker signatures (protein and/or RNA) that are measurable prior to onset of HD clinical symptoms. [ Time Frame: One year ]
  • Cerebral spinal fluid biomarker changes correlating with HD progression. [ Time Frame: One year ]
  • Changes in HD cerebral spinal fluid biomarker signatures correlating with response to treatment. [ Time Frame: One year ]
  • Levels of cerebral spinal fluid protein oxidation measured higher in HD patients prior to diagnosis, and these levels increase with neurodegeneration. [ Time Frame: One year ]
  • Cerebral spinal fluid microRNA miR-34b expression increased in presymptomatic HD patients, and decreased in later stages of the illness. [ Time Frame: One year ]
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Neurobiological Predictors of Huntington's Disease (PREDICT-HD)
Neurobiological Predictors of Huntington's Disease Trial
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.

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.

Observational Model: Cohort
Time Perspective: Prospective
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Retention:   Samples With DNA

Cerebral spinal fluid acquired and retained since 2012.

Plasma retained from 2000-2007. Urine, plasma and cell lines to be acquired and retained 2008-2013.

Non-Probability Sample
People at risk for HD, who have been tested for the HD gene mutation, and who have not been diagnosed with symptoms of HD.
Huntington Disease
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Epping EA, Kim JI, Craufurd D, Brashers-Krug TM, Anderson KE, McCusker E, Luther J, Long JD, Paulsen JS; PREDICT-HD Investigators and Coordinators of the Huntington Study Group. Longitudinal Psychiatric Symptoms in Prodromal Huntington's Disease: A Decade of Data. Am J Psychiatry. 2016 Feb 1;173(2):184-92. doi: 10.1176/appi.ajp.2015.14121551. Epub 2015 Oct 16.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Active, not recruiting
August 2017
August 2017   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • men and women at risk for HD, who have been tested for the HD gene mutation, and who have not been diagnosed with symptoms of HD (CAG ≥36 for CAG-expanded group or CAG <36 for CAG-norm group).

Exclusion Criteria:

  • diagnosis of manifest HD (at least 50% confidence by neurologist that symptoms are present);
  • clinical evidence of unstable medical or psychiatric illness (including substance abuse);
  • history of sever learning disability or mental retardation;
  • history of other CNS disease or event (e.g., seizures or head trauma);
  • current treatment with antipsychotic medications, including the traditional neuroleptics such as haloperidol as well as the atypical antipsychotics risperidone, clozapine, quetiapine, and olanzapine;
  • treatment with phenothiazine-derivative antiemetic medications such as prochlorperazine, metoclopramide, promethazine, and Inapsine on a regular basis (greater than 3 times per month);

Specific exclusion criteria for the lumbar puncture:

  • Current use of anti-coagulants
  • Current use of anti-platelets
  • Unable to provide consent for him/herself
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
Australia,   Canada,   Germany,   United Kingdom,   United States
R01NS040068 ( U.S. NIH Grant/Contract )
Not Provided
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Jane S. Paulsen, University of Iowa
University of Iowa
National Institute of Neurological Disorders and Stroke (NINDS)
Principal Investigator: Jane S. Paulsen, Ph.D. University of Iowa
University of Iowa
October 2016