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

NCT ID: NCT00051324

Last Updated: 2025-01-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

1700 participants

Study Classification

OBSERVATIONAL

Study Start Date

2002-08-31

Study Completion Date

2025-06-30

Brief Summary

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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

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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

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Huntington Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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);


* Current use of anti-coagulants
* Current use of anti-platelets
* Unable to provide consent for him/herself
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Neurological Disorders and Stroke (NINDS)

NIH

Sponsor Role collaborator

Jordan Schultz

OTHER

Sponsor Role lead

Responsible Party

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Jordan Schultz

Assistant Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Jane S. Paulsen, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Iowa

Locations

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University of Iowa

Iowa City, Iowa, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 30644132 (View on PubMed)

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.

Reference Type DERIVED
PMID: 29282329 (View on PubMed)

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.

Reference Type DERIVED
PMID: 26472629 (View on PubMed)

Related Links

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http://www.youtube.com/user/PREDICTHD

PREDICT-HD YouTube Channel

Other Identifiers

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R01NS040068

Identifier Type: NIH

Identifier Source: secondary_id

View Link

199904075

Identifier Type: -

Identifier Source: org_study_id

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