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Trial record 1 of 2 for:    Predict-HD
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Neurobiological Predictors of Huntington's Disease (PREDICT-HD) (PREDICT-HD)

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00051324
First Posted: January 9, 2003
Last Update Posted: November 29, 2017
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.
Collaborator:
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
November 29, 2017
August 2002
August 31, 2017   (Final data collection date for primary outcome measure)
  • 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.
  • 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.

  • 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.

Not Provided
Complete list of historical versions of study NCT00051324 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
  • Cerebral spinal fluid containing unique biomarker signatures. [ Time Frame: One year ]
    Lumbar puncture is conducted at the University of Iowa
  • Cerebral spinal fluid biomarker changes correlating with HD progression. [ Time Frame: One year ]
    Lumbar puncture is conducted at the University of Iowa
Not Provided
 
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
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

Cerebral spinal fluid acquired and retained since 2012.

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

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
Not Provided
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
1500
December 2018
August 31, 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)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
Australia,   Canada,   Germany,   Spain,   United Kingdom,   United States
 
NCT00051324
199904075
R01NS040068 ( U.S. NIH Grant/Contract )
No
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
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
Supporting Materials: 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.
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
November 2017