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

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.
ClinicalTrials.gov Identifier: NCT00051324
Recruitment Status : Active, not recruiting
First Posted : January 9, 2003
Last Update Posted : November 29, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease
Huntington Disease

Detailed Description:

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.


Study Design

Study Type : Observational
Actual Enrollment : 1500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Neurobiological Predictors of Huntington's Disease Trial
Study Start Date : August 2002
Primary Completion Date : August 31, 2017
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts


Outcome Measures

Primary Outcome Measures :
  1. Refine the prediction of disease diagnosis (motor conversion) [ 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, stroop interference and motor score.

  2. Characterize disease progression prior to diagnosis. [ Time Frame: One year ]

    Document change scores for each marker using its slope.

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


  3. Establish possible validity and reliability of disease measures. [ 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.



Other Outcome Measures:
  1. Cerebral spinal fluid containing unique biomarker signatures. [ Time Frame: One year ]
    Lumbar puncture is conducted at the University of Iowa

  2. Cerebral spinal fluid biomarker changes correlating with HD progression. [ Time Frame: One year ]
    Lumbar puncture is conducted at the University of Iowa


Biospecimen Retention:   Samples With DNA

Cerebral spinal fluid acquired and retained since 2012.

Urine, plasma and cell lines to be acquired and retained since study initiation 2002.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
People at risk for HD, who have been tested for the HD gene mutation, and who have not been diagnosed with symptoms of HD.
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00051324


Sponsors and Collaborators
University of Iowa
National Institute of Neurological Disorders and Stroke (NINDS)
Investigators
Principal Investigator: Jane S. Paulsen, Ph.D. University of Iowa
More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jane S. Paulsen, Professor, University of Iowa
ClinicalTrials.gov Identifier: NCT00051324     History of Changes
Other Study ID Numbers: 199904075
R01NS040068 ( U.S. NIH Grant/Contract )
First Posted: January 9, 2003    Key Record Dates
Last Update Posted: November 29, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All data have been de-identified and anonymized with the best possible methods to allow and facilitate data sharing with other investigators. Data has been shared to CHDI and dbGaP.
Supporting Materials: Study Protocol
Clinical Study Report (CSR)
Time Frame: Data will be on dbGaP and at CHDI for data sharing with no anticipated endpoint.
Access Criteria: NINDS monitors dbGaP and CHDI scientific staff monitors their data copy.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Jane S. Paulsen, University of Iowa:
Huntington's disease
Huntington disease
HD

Additional relevant MeSH terms:
Huntington Disease
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Dementia
Chorea
Dyskinesias
Movement Disorders
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Genetic Diseases, Inborn
Cognition Disorders
Neurocognitive Disorders
Mental Disorders