Huntington's DiseaseChANGE HDNCT01860339
Child to Adult Neurodevelopment in Gene Expanded Huntington's Disease
An observational study of Huntington's Disease, run by Peggy C Nopoulos at 6 sites in United States.
Trial summary
Huntington's Disease (HD) is an autosomal dominant disease manifested in a triad of cognitive, psychiatric, and motor signs and symptoms. HD is caused by a triplet repeat (CAG)expansion in the gene Huntingtin (HTT). This disease has classically been conceptualized as a neurodegenerative disease. Read more about this study
- Who is it for?
- Ages 6 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Huntington's Disease
- How many people
- 488 participants
- Where
- 6 sitesUnited States
- Study dates
- Jul 2005to 31 Mar 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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 6 to 30 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Young people ages 6-30 years old who have a parent or grandparent that has been diagnosed with Huntington's Disease
Who may be able to join
- Family history of Huntington's Disease
- Age 6-30 years
- Age-appropriate knowledge of HD and personal risk
Who cannot join
- Metal in body, including braces
- History of head trauma, brain tumor, seizures, epilepsy
- History of major surgery and/or significant ongoing medical issue(s)
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
University of Texas Health Science Center at Houston
Houston, Texas, 77030
University of Iowa Hospitals and Clinics, Department of Psychiatry
Iowa City, Iowa, 52242
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Columbia University Medical Center
New York, New York, 10027
Children's Hospital of Philadelphia with the University of Pennsylvania
Philadelphia, Pennsylvania, 19146
University of California Davis
Sacramento, California, 95817
About this study
Official title: Growth and Development of Striatal-Cerebellum Circuitry in Subjects at Risk for Huntington's Disease
Huntington's Disease (HD) is an autosomal dominant disease manifested in a triad of cognitive, psychiatric, and motor signs and symptoms. HD is caused by a triplet repeat (CAG)expansion in the gene Huntingtin (HTT). This disease has classically been conceptualized as a neurodegenerative disease. However, recent evidence suggests that abnormal brain development may play an important role in the etiology of HD. Huntingtin (HTT)is expressed during development and through life. In animal studies, the HTT gene has been shown to be vital for brain development. This suggests that a mutant form of HTT (gene-expanded or CAG repeats of 40 and above) would affect normal brain development. In addition, studies in adults who are gene-expanded for HD, but have not yet manifested the illness, (pre-HD subjects) have significant changes in the structure of their brain, even up to 20 years before onset of clinical diagnosis. How far back these changes are evident is unknown. One possibility is that these brain changes are present throughout life, due to changes in brain development,though initially associated with only subtle functional abnormalities.
In an effort to better understand the developmental aspects of this brain disease, the current study proposes to evaluate brain structure and function in children, adolescents, and young adults (ages 6-30) who are at risk for developing HD - those who have a parent or grandparent with HD. Brain structure will be evaluating using Magnetic Resonance Imaging (MRI) with quantitative measures of the entire brain, cerebral cortex, as well as white matter integrity via Diffusion Tensor Imaging. Brain function will be assessed by cognitive tests, behavioral assessment, and physical and neurologic evaluation. Subjects that are gene-expanded (GE) will be compared to subjects who are gene non-expanded (GNE). Changes in brain structure and/or function in the GE group compared to the GNE group would lend support to the notion that this disease has an important developmental component.
- Conditions
- Huntington's Disease
- Keywords
- Huntington's Disease, HD, Huntington Disease
- Medical subject headings
- Huntington Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Gene-expanded (GE) | Children at risk for HD who have a CAG repeat length of 40 and above. | |
| Gene Non-Expanded (GNE) | Children at risk for HD who have a CAG repeat length of 39 or less |
What is being measured
The primary outcome is the main question the study is designed to answer.
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, all in consideration of age, gender, and height. Results will be evaluated for comparative differences between the GE group and the GNE group. In addition, these measures of brain structure will be paired with corresponding measures of brain function to evaluate brain development based upon growth and performance.
Measured: 1 hour out of 6-7 hour testing day, 3-4 annual visits
Secondary outcomes (1)
Quantitative assessment of cognitive skills and behavioral factors
Participants undergo a cognitive battery which will quantify skills such as attention, learning, memory. In addition, behavioral measures will be administered in both self and proxy report formats. Results will be analyzed for comparative differences between the GE group and the GNE group. In addition, these measures of brain function will be paired with appropriate measures of brain structure to evaluate brain development based upon growth and performance.
Measured: 4 hours out of 6-7 hour testing day, 3-4 annual visits
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2013 (estimated)
- Study startJul 2005
- Primary completion31 Mar 2026
- Study completion31 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Huntington's 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 488 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peggy C Nopoulos
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Peggy C Nopoulos, University of Iowa
- Investigators
- Peggy C Nopoulos, MD, Principal investigator, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01860339
- Sponsor's protocol ID
- 200507759
- Other IDs
- 2U01NS055903-10, 5U01NS055903-14
- Acronym
- ChANGE HD
- Status last verified
- Apr 2026
- First submitted
- 16 May 2013
- Last updated
- 30 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: Aggregate, de-identified data may be shared with approved collaborators, but individual participant data will not be shared.
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Growth and Development of Striatal-Cerebellum Circuitry in Subjects at Risk for Huntington's Disease
- ClinicalTrials.gov ID
- NCT01860339
- Acronym / sponsor ID
- ChANGE HD / 200507759
- Conditions
- Huntington's Disease
- Keywords
- Huntington's Disease, HD, Huntington Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 488 participants (actual)
- Lead sponsor
- Peggy C NopoulosUniversity, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS)
- Study start
- Jul 2005 (actual)
- Primary completion
- 31 Mar 2026 (actual)
- Study completion
- 31 Mar 2026 (actual)
- First posted
- 22 May 2013 (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.
Huntington's Disease (HD) is an autosomal dominant disease manifested in a triad of cognitive, psychiatric, and motor signs and symptoms. HD is caused by a triplet repeat (CAG)expansion in the gene Huntingtin (HTT). This disease has classically been conceptualized as a neurodegenerative disease. However, recent evidence suggests that abnormal brain development may play an important role in the etiology of HD. Huntingtin (HTT)is expressed during development and through life. In animal studies, the HTT gene has been shown to be vital for brain development. This suggests that a mutant form of HTT (gene-expanded or CAG repeats of 40 and above) would affect normal brain development. In addition, studies in adults who are gene-expanded for HD, but have not yet manifested the illness, (pre-HD subjects) have significant changes in the structure of their brain, even up to 20 years before onset of clinical diagnosis. How far back these changes are evident is unknown. One possibility is that these brain changes are present throughout life, due to changes in brain development,though initially associated with only subtle functional abnormalities.
In an effort to better understand the developmental aspects of this brain disease, the current study proposes to evaluate brain structure and function in children, adolescents, and young adults (ages 6-30) who are at risk for developing HD - those who have a parent or grandparent with HD. Brain structure will be evaluating using Magnetic Resonance Imaging (MRI) with quantitative measures of the entire brain, cerebral cortex, as well as white matter integrity via Diffusion Tensor Imaging. Brain function will be assessed by cognitive tests, behavioral assessment, and physical and neurologic evaluation. Subjects that are gene-expanded (GE) will be compared to subjects who are gene non-expanded (GNE). Changes in brain structure and/or function in the GE group compared to the GNE group would lend support to the notion that this disease has an important developmental component.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gene-expanded (GE) | – | –Children at risk for HD who have a CAG repeat length of 40 and above. |
| Gene Non-Expanded (GNE) | – | –Children at risk for HD who have a CAG repeat length of 39 or less |
Who may qualify
- Ages
- 6 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Young people ages 6-30 years old who have a parent or grandparent that has been diagnosed with Huntington's Disease
Key inclusion criteria (3 listed)
- Family history of Huntington's Disease
- Age 6-30 years
- Age-appropriate knowledge of HD and personal risk
Key exclusion criteria (3 listed)
- Metal in body, including braces
- History of head trauma, brain tumor, seizures, epilepsy
- History of major surgery and/or significant ongoing medical issue(s)
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
Volume of brain structures as measured by Magnetic Resonance Imaging (MRI)
Time frame: 1 hour out of 6-7 hour testing day, 3-4 annual visits
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, all in consideration of age, gender, and height. Results will be evaluated for comparative differences between the GE group and the GNE group. In addition, these measures of brain structure will be paired with corresponding measures of brain function to evaluate brain development based upon growth and performance.
1 secondary outcome
Quantitative assessment of cognitive skills and behavioral factors
Time frame: 4 hours out of 6-7 hour testing day, 3-4 annual visits
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2026.
- Previous study siteLink provided by the sponsor.
- Facebook pageLink provided by the sponsor.
- Twitter accountLink provided by the sponsor.
- Individual participant dataSharing planned: No. Aggregate, de-identified data may be shared with approved collaborators, but individual participant data will not be shared.
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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.
Peggy C Nopoulos, MD principal investigator
University of Iowa
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Huntington's Disease, run by Peggy C Nopoulos at 6 sites 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 3 inclusion and 3 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: finished, as of the sponsor's last update on 30 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Volume of brain structures as measured by Magnetic Resonance Imaging (MRI) (time frame: 1 hour out of 6-7 hour testing day, 3-4 annual visits). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Apr 2026.