Natural History Study in Huntington Disease Gene Expansion Carriers (HDGECs) - SHIELD HD (SHIELD HD)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04406636|
Recruitment Status : Active, not recruiting
First Posted : May 28, 2020
Last Update Posted : November 19, 2020
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.
|Condition or disease|
|Study Type :||Observational|
|Actual Enrollment :||70 participants|
|Official Title:||Natural History Study in Prodromal and Manifest Huntington Disease Gene Expansion Carriers (HDGECs) - SHIELD HD|
|Actual Study Start Date :||May 19, 2020|
|Estimated Primary Completion Date :||November 2022|
|Estimated Study Completion Date :||December 2022|
- DDR gene expression [ Time Frame: 2 years ]To assess deoxyribonucleic acid (DNA) damage repair (DDR) gene expression in accessible biofluids and disease trajectories for established and novel biomarkers and clinical outcomes.
- Compare rates of change in biomarkers for disease progression [ Time Frame: 2 years ]To compare the rates of change for different outcomes and cytosine adenine guanine (CAG) age product (CAP) Scores.
- Additional biomarkers to be examined [ Time Frame: 2 years ]The exploratory objectives of this study are to be determined and may include the examination of additional biomarkers present in CSF, plasma, and whole blood, including but not limited to mutant HTT (mHTT) protein, cytokines, and others, as well as clinical markers of progression.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04406636
|United States, California|
|University of California, San Diego (UCSD)|
|San Diego, California, United States, 920161|
|United States, Colorado|
|Rocky Mountain Movement Disorders Center|
|Englewood, Colorado, United States, 80113|
|United States, Massachusetts|
|Beth Israel Deaconess|
|Boston, Massachusetts, United States, 02215|
|United States, New York|
|New York, New York, United States, 10032|
|United States, Washington|
|Inland Northwest Research|
|Spokane, Washington, United States, 99202|
|Centre for Movement Disorders|
|Toronto, Ontario, Canada, M3B 257|
|ICM - Institut du Cerveau et de la Moelle épinière|
|Paris, France, 75013|
|University College London - Institute of Neurology & The National Hospital for Neurology and Neurosurgery|
|London, United Kingdom|
|Principal Investigator:||Anne Rosser, PhD FRCP||Cardiff University|