Huntington DiseasePREDICT-HDNCT00051324
Neurobiological Predictors of Huntington's Disease (PREDICT-HD)
An observational study of Huntington Disease, run by Jordan Schultz at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Huntington Disease
- How many people
- 1,700 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2002to 30 Jun 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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).
Who cannot join
- 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);
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- Specific exclusion criteria for the lumbar puncture:
- Current use of anti-coagulants
- Current use of anti-platelets
- Unable to provide consent for him/herself
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Huntington Disease
- Keywords
- Huntington's disease, Huntington disease, HD
- Medical subject headings
- Huntington Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2003 (estimated)
- Study startAug 2002
- Primary completion30 Jun 2025 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Huntington DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jordan Schultz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jordan Schultz, University of Iowa
- Investigators
- Jane S. Paulsen, Ph.D., Principal investigator, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00051324
- Sponsor's protocol ID
- 199904075
- Other IDs
- R01NS040068
- Acronym
- PREDICT-HD
- Status last verified
- Jan 2025
- First submitted
- 8 Jan 2003
- Last updated
- 14 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 41363816Paulsen 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.
PubMed 30644132Reed 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.
PubMed 29282329Epping 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.
PubMed 26472629
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurobiological Predictors of Huntington's Disease Trial
- ClinicalTrials.gov ID
- NCT00051324
- Acronym / sponsor ID
- PREDICT-HD / 199904075
- Conditions
- Huntington Disease
- Keywords
- Huntington's disease, Huntington disease, HD
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,700 participants (estimated)
- Lead sponsor
- Jordan SchultzUniversity, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS)
- Study start
- Aug 2002
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 9 Jan 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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).
Key exclusion criteria (10 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2025.
- Derived from this study: PubMed 41363816Chelsky 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.
- Derived from this study: PubMed 30644132Paulsen 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.
- Derived from this study: PubMed 29282329Reed 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.
- Derived from this study: PubMed 26472629Epping 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.
- PREDICT-HD YouTube ChannelLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jane S. Paulsen, Ph.D. principal investigator
University of Iowa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Huntington Disease, run by Jordan Schultz at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 14 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Refine the prediction of disease diagnosis (motor conversion) (time frame: One year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00051324, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2025.