NCT05707663

Brief Summary

The goal of this observational study is to learn about brain development in Juvenile-onset Huntington's Disease (JoHD). The main questions it aims to answer are:

  • Is brain development different in JoHD than Adult-onset Huntington's Disease (AoHD)?
  • Can reliable biomarkers for JoHD be found in brain structure and function? Participants will be asked to complete cognitive tests, behavioral assessments, physical and neurologic evaluation, and MRI. Data collected will be compared to populations who are at-risk for HD and who have been diagnosed with HD as adults.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
37

participants targeted

Target at P25-P50 for all trials

Timeline
4mo left

Started Jan 2020

Longer than P75 for all trials

Geographic Reach
1 country

5 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress95%
Jan 2020Aug 2026

Study Start

First participant enrolled

January 1, 2020

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

December 16, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 1, 2023

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2026

Last Updated

April 30, 2026

Status Verified

March 1, 2026

Enrollment Period

6.7 years

First QC Date

December 16, 2022

Last Update Submit

April 25, 2026

Conditions

Keywords

JoHDJHDJuvenile Huntington DiseaseJuvenile Huntington's DiseaseJuvenile-onset Huntington Disease

Outcome Measures

Primary Outcomes (1)

  • Volume of brain structures as measured by Magnetic Resonance Imaging (MRI)

    Magnetic Resonance Imaging (MRI) and Diffusion Tensor Imaging (DTI) data will be analyzed to assess brain structure based upon variables including global volume, total cerebral spinal fluid, subregion volumes, cortical surface anatomy including cortical depth, surface area and gyral shape, and symmetry between brain hemispheres.

    60-90 minutes out of 7-8 hour testing day

Secondary Outcomes (1)

  • Quantitative assessment of cognitive skills and behavioral factors

    5 hours out of 7-8 hour testing day

Other Outcomes (3)

  • Quantitative assessment of motor performance

    1 hour out of 7-8 hour testing day

  • Quantification of Neurofilament Light

    10 minutes for blood draw out of 7-8 hour testing day

  • Demographic and Physiological Data

    10 minutes for vitals collection out of 7-8 hour testing day

Study Arms (1)

JoHD

Children, adolescents, and young adults ages 4-30 who have been clinically diagnosed with Juvenile-onset Huntington's Disease

Eligibility Criteria

Age4 Years - 30 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Children, adolescents and young adults ages 4-30 who have been clinically diagnosed with Juvenile-onset Huntington's Disease

You may qualify if:

  • Clinical diagnosis of JoHD
  • Aged 4-30

You may not qualify if:

  • Metal in body
  • History of head trauma, brain tumor, seizures or epilepsy unrelated to JoHD
  • History of major surgery or serious chronic medical conditions other than JoHD

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

University of California Davis

Sacramento, California, 95817, United States

Location

University of Iowa Hospitals and Clinics, Department of Psychiatry

Iowa City, Iowa, 52242, United States

Location

Children's Hospital of Philadelphia with the University of Pennsylvania

Philadelphia, Pennsylvania, 19146, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

Related Publications (1)

  • Nopoulos PC. Special Issue: Juvenile Onset Huntington's Disease. Brain Sci. 2020 Sep 20;10(9):652. doi: 10.3390/brainsci10090652.

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

Bio-specimens are collected and retained for all participants for future research. Specimens are a single sample of 3-4 teaspoons of blood drawn from the arm that consist of whole blood, plasma and DNA.

MeSH Terms

Conditions

Huntington Disease

Condition Hierarchy (Ancestors)

Basal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesDementiaChoreaDyskinesiasMovement DisordersHeredodegenerative Disorders, Nervous SystemNeurodegenerative DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesCognition DisordersNeurocognitive DisordersMental Disorders

Study Officials

  • Peggy C Nopoulos, MD

    University of Iowa

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 16, 2022

First Posted

February 1, 2023

Study Start

January 1, 2020

Primary Completion (Estimated)

August 31, 2026

Study Completion (Estimated)

August 31, 2026

Last Updated

April 30, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Aggregate, de-identified data may be shared with approved collaborators, but individual participant data will not be shared.

Locations