Neurobiological Predictors of Huntington's Disease (PREDICT-HD) (PREDICT-HD)
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|ClinicalTrials.gov Identifier: NCT00051324|
Recruitment Status : Recruiting
First Posted : January 9, 2003
Last Update Posted : February 27, 2023
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|Condition or disease|
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 Type :||Observational|
|Estimated Enrollment :||1700 participants|
|Official Title:||Neurobiological Predictors of Huntington's Disease Trial|
|Study Start Date :||August 2002|
|Estimated Primary Completion Date :||March 31, 2023|
|Estimated Study Completion Date :||March 31, 2023|
- 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.
- 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
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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
|Sampling Method:||Non-Probability Sample|
- 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).
- 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
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
|Contact: Jane S Paulsen, PhDfirstname.lastname@example.org|
|United States, Iowa|
|University of Iowa||Recruiting|
|Iowa City, Iowa, United States, 52242|
|Contact: Jane S Paulsen, PhD 319-331-4713 email@example.com|
|Principal Investigator: Jane S Paulsen, PhD|
|Principal Investigator:||Jane S. Paulsen, Ph.D.||University of Iowa|
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
|Responsible Party:||University of Iowa|
|Other Study ID Numbers:||
R01NS040068 ( U.S. NIH Grant/Contract )
|First Posted:||January 9, 2003 Key Record Dates|
|Last Update Posted:||February 27, 2023|
|Last Verified:||February 2023|
|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.|
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|
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