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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by University of Iowa
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Jane S. Paulsen, University of Iowa
ClinicalTrials.gov Identifier:
NCT00051324
First received: January 8, 2003
Last updated: December 5, 2013
Last verified: December 2013

January 8, 2003
December 5, 2013
August 2002
August 2014   (final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT00051324 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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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, and neurological and psychiatric testing.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

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
Not Provided
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1500
August 2014
August 2014   (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;
  • history of mental retardation;
  • history of other CNS disease or event (e.g., seizures or head trauma);
  • current or previous 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);
  • pacemaker or metallic implants.
Both
18 Years and older
No
Contact: Sean Thompson 319-353-4307 predict-hd@uiowa.edu
United Kingdom,   United States,   Australia,   Canada,   Germany
 
NCT00051324
R01NS040068, R01NS040068
No
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
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP