NCT04406636

Brief Summary

SHIELD HD is an international, multisite, prospective, longitudinal cohort natural history study to assess the natural history of HD and its biomarkers that are associated with modulation of the number of cytosine-adenine-guanine (CAG) repeats in the mutant Huntingtin (HTT) gene. Approximately 60 patients will be enrolled into the study and followed for up to 24 months at clinical sites in North America and Europe. The results of this study will inform assessments for a future interventional treatment trial.

Trial Health

50
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2020

Typical duration for all trials

Geographic Reach
5 countries

10 active sites

Status
unknown

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 Start

First participant enrolled

May 19, 2020

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

May 20, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 28, 2020

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2023

Completed
Last Updated

September 23, 2022

Status Verified

September 1, 2022

Enrollment Period

2.9 years

First QC Date

May 20, 2020

Last Update Submit

September 21, 2022

Conditions

Huntington Disease

Keywords

HD

Outcome Measures

Primary Outcomes (1)

  • DDR gene expression

    To assess deoxyribonucleic acid (DNA) damage repair (DDR) gene expression in accessible biofluids and disease trajectories for established and novel biomarkers and clinical outcomes.

    2 years

Secondary Outcomes (1)

  • Compare rates of change in biomarkers for disease progression

    2 years

Other Outcomes (1)

  • Additional biomarkers to be examined

    2 years

Eligibility Criteria

Age18 Years - 63 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Huntington disease (HD), genetically confirmed by direct DNA testing, either obtained previously or performed at Screening

You may qualify if:

  • Patients who meet all of the following criteria will be eligible to participate in the study:
  • Capacity to comprehend the study objectives and procedures
  • Documentation of genetically confirmed disease by direct DNA testing, defined as a CAG repeat length ≥39 in the HTT gene
  • Ability to undergo and tolerate MRI scans
  • Ability to tolerate blood draws and lumbar punctures

You may not qualify if:

  • Patients who meet any of the following criteria will be excluded from participation in the study:
  • Any conditions, including severe chorea and dementia, that would prevent either writing or performing pen and paper, tablet, or computer based tasks as determined by the Investigator
  • Treatment with an investigational drug within 30 days prior to screening or within 5 half lives of the investigational drug, whichever is longer
  • History of gene therapy or cell transplantation or any other experimental brain surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

University of California, San Diego (UCSD)

San Diego, California, 920161, United States

Location

Rocky Mountain Movement Disorders Center

Englewood, Colorado, 80113, United States

Location

Beth Israel Deaconess

Boston, Massachusetts, 02215, United States

Location

Columbia University

New York, New York, 10032, United States

Location

Inland Northwest Research

Spokane, Washington, 99202, United States

Location

Centre for Movement Disorders

Toronto, Ontario, M3B 257, Canada

Location

North York General Hospital

Toronto, Ontario, Canada

Location

ICM - Institut du Cerveau et de la Moelle épinière

Paris, 75013, France

Location

George-Huntington-Institut (GHI)

Münster, Germany

Location

University College London - Institute of Neurology & The National Hospital for Neurology and Neurosurgery

London, United Kingdom

Location

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

  • Anne Rosser, PhD FRCP

    Cardiff University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 20, 2020

First Posted

May 28, 2020

Study Start

May 19, 2020

Primary Completion

April 1, 2023

Study Completion

April 1, 2023

Last Updated

September 23, 2022

Record last verified: 2022-09

Locations

US(5)GB(1)FR(1)DE(1)CA(2)