NCT00051324|Active Not Recruiting
Neurobiological Predictors of Huntington's Disease (PREDICT-HD)
PREDICT-HD
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PREDICT-HD
Sponsor study identifier
Secondary identifiers
NIH
observational
1,700
1 country
1
Study Start
August 2002
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
June 30, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
June 30, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 30, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 2002
Date type not reportedThis date has not been verified as actual or estimated.
January 8, 2003
Actual (reported)January 9, 2003
Actual (reported)June 30, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
June 30, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Refine the prediction of disease diagnosis (motor conversion)
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.
One year
Characterize disease progression prior to diagnosis.
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.
One year
Establish possible validity and reliability of disease measures.
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.
One year
Cerebral spinal fluid containing unique biomarker signatures.
One year
Cerebral spinal fluid biomarker changes correlating with HD progression.
One year
People at risk for HD, who have been tested for the HD gene mutation, and who have not been diagnosed with symptoms of HD.
University of Iowa
Iowa City, Iowa, 52242, United States
Chelsky D, Joyce C, Bockholt HJ, Rudnick PA, Adams WH, McAllister F, Smock JW, Newton MA, Paulsen JS. Discovery and Targeted Proteomic Studies Reveal Striatal Markers Validated for Huntington's Disease. Ann Clin Transl Neurol. 2026 May;13(5):911-923. doi: 10.1002/acn3.70272. Epub 2025 Dec 9.
Paulsen JS, Lourens S, Kieburtz K, Zhang Y. Sample enrichment for clinical trials to show delay of onset in huntington disease. Mov Disord. 2019 Feb;34(2):274-280. doi: 10.1002/mds.27595. Epub 2019 Jan 14.
Cerebral spinal fluid acquired and retained since 2012. Urine, plasma and cell lines to be acquired and retained since study initiation 2002.
Jane S. Paulsen, Ph.D.
University of Iowa
First Submitted
January 8, 2003
First Posted
January 9, 2003
Study Start
August 2002
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
June 30, 2025
Study of Memantine to Treat Huntington's Disease
Contact the study team to confirm eligibility.
Reed ER, Latourelle JC, Bockholt JH, Bregu J, Smock J, Paulsen JS, Myers RH; PREDICT-HD CSF ancillary study investigators. MicroRNAs in CSF as prodromal biomarkers for Huntington disease in the PREDICT-HD study. Neurology. 2018 Jan 23;90(4):e264-e272. doi: 10.1212/WNL.0000000000004844. Epub 2017 Dec 27.
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.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
June 30, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
January 14, 2025
Record last verified: 2025-01
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.
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Source: ClinicalTrials.gov.
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