NCT00313495

Brief Summary

The purpose of this study is to collect prospective data from individuals who are part of a Huntington Disease (HD) family, in order to relate phenotypes between individuals and families with each other and genetic factors in order to learn more about HD, develop potential treatments for HD, and to plan for future research studies of experimental drugs aimed at slowing or postponing the onset and progression of HD.

Trial Health

47
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
5,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2006

Longer than P75 for all trials

Geographic Reach
3 countries

52 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

February 1, 2006

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 10, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 12, 2006

Completed
14.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

March 7, 2011

Status Verified

March 1, 2011

Enrollment Period

14.8 years

First QC Date

April 10, 2006

Last Update Submit

March 4, 2011

Conditions

Keywords

Huntington disease, observational, family members, biomarker

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

1. An individual of any age that is affected by Huntington's disease 2. An individual 18 years of age or older, who has tested positive for the HD gene 3. An individual 18 years of age or older who is a parent, sibling or child of an individual affected by HD 4. An older adolescent 15 to 17 years of age, who has a parent affected by HD enrolled in COHORT, or a parent who has tested positive for the HD gene enrolled in COHORT (at select sites) 5. Grandparents and grandchildren of anyone participating in COHORT who fulfills the requirements of (the above) category (1) or (2) 6. HD family members who have no risk for HD due to no family history (spouses or caregivers) 7. HD family members who have undergone DNA testing and does not carry the genetic mutation responsible for HD.

You may qualify if:

  • (1) MANIFEST/PRE-MANIFEST HD: Individuals of any age who are affected by HD OR an individual 18 years or older who - has tested positive for the HD gene.
  • (2) INDIVIDUALS AT RISK: An individual 18 years or older who has not undergone DNA testing for the mutation responsible for HD and who is a first degree relative (parent, sibling, child) of an individual with Manifest or pre-manifest HD OR an older adolescent 15 to 17 years of age who has a parent with manifest HD or pre-manifest HD enrolled in COHORT.
  • (3) ADULTS AT SECONDARY RISK: An individual 18 years of age or older who has not undergone DNA testing for the mutation responsible for HD and is a grandparent or grandchild of an individual enrolled in COHORT who has manifest HD or pre-manifest HD
  • (4) CONTROL: A spouse or caregiver, 18 years of age or older, of an individual enrolled in COHORT who has manifest HD or pre-manifest HD
  • (5) ADULT GENE NEGATIVE: An individual, 18 years of age or older, with a family history of HD who has undergone DNA testing and does not carry the genetic mutation responsible for HD.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (52)

University of Alabama at Birmingham

Birmingham, Alabama, United States

TERMINATED

UCLA School of Medicine

Los Angeles, California, United States

RECRUITING

University of California, Davis

Sacramento, California, United States

RECRUITING

University of California, San Diego

San Diego, California, United States

RECRUITING

University of California, San Francisco

San Francisco, California, 94143, United States

RECRUITING

Colorado Neurological Institute

Littleton, Colorado, United States

RECRUITING

University of Connecticut

Hartford, Connecticut, United States

RECRUITING

Institutue for Neurodegenerative Disorders

New Haven, Connecticut, United States

RECRUITING

University of Miami School of Medicine

Miami, Florida, United States

RECRUITING

University of South Florida

Tampa, Florida, United States

RECRUITING

Emory University

Atlanta, Georgia, United States

RECRUITING

Medical College of Georgia

Augusta, Georgia, United States

RECRUITING

Rush University Medical Center

Chicago, Illinois, United States

RECRUITING

University of Chicago

Chicago, Illinois, United States

RECRUITING

Indiana University School of Medicine

Indianapolis, Indiana, United States

RECRUITING

University of Iowa

Iowa City, Iowa, United States

RECRUITING

University of Kansas Medical Center

Kansas City, Kansas, United States

RECRUITING

Hereditary Neurological Disease Center

Wichita, Kansas, United States

RECRUITING

University of Louisville

Louisville, Kentucky, 40294, United States

RECRUITING

Johns Hopkins University

Baltimore, Maryland, United States

RECRUITING

University of Maryland

Baltimore, Maryland, United States

RECRUITING

Boston University School of Medicine

Boston, Massachusetts, United States

RECRUITING

Massachusetts General Hospital

Boston, Massachusetts, United States

RECRUITING

Hennepin County Medical Center

Minneapolis, Minnesota, United States

ACTIVE NOT RECRUITING

Washington University School of Medicine

St Louis, Missouri, United States

RECRUITING

Albany Medical College

Albany, New York, United States

RECRUITING

Columbia University

New York, New York, United States

RECRUITING

University of Rochester

Rochester, New York, United States

RECRUITING

Duke University Medical Center

Durham, North Carolina, United States

RECRUITING

Wake Forest University Baptist Medical Center

Winston-Salem, North Carolina, United States

RECRUITING

University of Cincinnati

Cincinnati, Ohio, United States

RECRUITING

The Cleveland Clinic

Cleveland, Ohio, United States

RECRUITING

Ohio State University

Columbus, Ohio, United States

RECRUITING

University of Pennsylvania

Philadelphia, Pennsylvania, United States

RECRUITING

University of Pittsburgh

Pittsburgh, Pennsylvania, United States

RECRUITING

University of Tennessee-Memphis

Memphis, Tennessee, United States

RECRUITING

Southwestern Medical Center

Dallas, Texas, 75390, United States

RECRUITING

Baylor College of Medicine

Houston, Texas, United States

RECRUITING

University of Utah

Salt Lake City, Utah, 84108, United States

RECRUITING

University of Virginia

Charlottesville, Virginia, United States

RECRUITING

Booth Gardner Parkinsons Center

Kirkland, Washington, 98034, United States

RECRUITING

Westmead Hospital

Wentworthville, New South Wales, Australia

RECRUITING

The University of Melbourne

Kew, Victoria, Australia

RECRUITING

Graylands, Selby-Lemnos & Special Care Health Services

Perth, Western Australia, 6910, Australia

RECRUITING

University of Calgary Medical Clinic

Calgary, Alberta, Canada

RECRUITING

University of British Columbia

Vancouver, British Columbia, Canada

RECRUITING

Movement Disorder Clinic Deer Lodge Centre

Winnipeg, Manitoba, Canada

RECRUITING

Movement Disorders Clinic, Deer Lodge Centre

Winnipeg, Manitoba, Canada

RECRUITING

Halifax Infirmary

Halifax, Nova Scotia, B3H1V7, Canada

RECRUITING

London Health Sciences Centre

London, Ontario, N6A 5A5, Canada

RECRUITING

The Centre for Addiction and Mental Health

Markham, Ontario, Canada

RECRUITING

Hotel-Dieu Hospital-CHUM

Montreal, Quebec, Canada

RECRUITING

Related Publications (3)

  • Connors MH, Teixeira-Pinto A, Loy CT. Psychosis and longitudinal outcomes in Huntington disease: the COHORT Study. J Neurol Neurosurg Psychiatry. 2020 Jan;91(1):15-20. doi: 10.1136/jnnp-2019-320646. Epub 2019 Oct 13.

  • Dorsey ER, Beck CA, Darwin K, Nichols P, Brocht AF, Biglan KM, Shoulson I; Huntington Study Group COHORT Investigators. Natural history of Huntington disease. JAMA Neurol. 2013 Dec;70(12):1520-30. doi: 10.1001/jamaneurol.2013.4408.

  • Huntington Study Group COHORT Investigators; Dorsey E. Characterization of a large group of individuals with huntington disease and their relatives enrolled in the COHORT study. PLoS One. 2012;7(2):e29522. doi: 10.1371/journal.pone.0029522. Epub 2012 Feb 16.

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

Blood, DNA and Urine

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

  • Ira Shoulson, MD

    University of Rochester/Huntington Study Group

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Huntington Study Group

CONTACT

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 10, 2006

First Posted

April 12, 2006

Study Start

February 1, 2006

Primary Completion

December 1, 2020

Study Completion

December 1, 2020

Last Updated

March 7, 2011

Record last verified: 2011-03

Locations