Enroll -HD: A Prospective Registry Study in a Global Huntington's Disease Cohort
1 other identifier
observational
35,000
19 countries
182
Brief Summary
Enroll-HD is a longitudinal, observational, multinational study that integrates two former Huntington's disease (HD) registries-REGISTRY in Europe, and COHORT in North America and Australasia-while also expanding to include sites in Latin America. More than 30,000 participants have now enrolled into the study. With annual assessments and no end date, Enroll-HD has built a large and rich database of longitudinal clinical data and biospecimens that form the basis for studies developing tools and biomarkers for progression and prognosis, identifying clinically-relevant phenotypic characteristics, and establishing clearly defined endpoints for interventional studies. Periodic cuts of the database are now available to any interested researcher to use in their research - visit www.enroll-hd.org/for-researchers/access-data/ to learn more.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2012
Longer than P75 for all trials
182 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 6, 2012
CompletedFirst Posted
Study publicly available on registry
April 10, 2012
CompletedStudy Start
First participant enrolled
July 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2062
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 1, 2062
February 28, 2024
February 1, 2024
49.5 years
April 6, 2012
February 26, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Motor Assessments: Unified Huntington's Disease Rating Scale (UHDRS) 99 Motor, UHDRS '99 Diagnostic Confidence Level
The motor section of the UHDRS assesses motor features of HD with standardized ratings of oculomotor function, dysarthria, chorea, dystonia, gait, and postural stability. UHDRS 99 Motor, UHDRS Diagnostic Confidence Level.
through study completion, an average of 1 year
Functional Assessments: UHDRS '99 Total Functional Capacity, UHDRS '99 Functional Assessment Scale, UHDRS '99 Independence Scale
The Total Functional Capacity, Functional Assessment and Independence Subscales of the UHDRS '99 will be used to assess participants' functional status. The Total Functional Capacity scale has established psychometric properties including inter-rater reliability and validity, based on radiographic measures of disease progression.
through study completion, an average of 1 year
Problem Behaviors Assessment-Short (PBA-s)
The Problem Behavioral Assessment Short Version (PBA-s) will be used to perform behavioral assessments. This instrument measures frequency and severity of symptoms related to altered affect, thought content and coping styles.
through study completion, an average of 1 year
Cognitive Assessments: Symbol Digit Modality Test; Stroop Color Naming; Stroop Word Reading; Categorical Verbal Fluency
Cognition will be assessed using the Categorical Verbal Fluency Test, Symbol Digit Modality Test and Stroop Color and Word Reading Test. Verbal fluency is a commonly used neuropsychological test which examines the ability to spontaneously produce words orally within a fixed time span. For category fluency, words must be produced according to semantic constraints. The measure of performance used will be the number of correctly generated words within 60 seconds.
through study completion, an average of 1 year
Eligibility Criteria
Patients with HD and their family members are recruited from specialty clinics (Human Genetics, Neurology, Psychiatry) that advise and treat people affected by HD. In addition, in some areas community clinics and neurologists who see HD patients recruit participants for this study. Participants also receive information about the study through websites, clinical practices, support groups, advocacy newsletters, etc. and place a direct request to be considered for participation in the study. Community controls are identified by study site staff (using advertisements, flyers and newsletters) with the support of the Enroll-HD operational staff.
You may qualify if:
- Carriers: This group comprises the primary study population and consists of individuals who carry the HD gene expansion mutation.
- Controls: This group comprises the comparator study population and consists of individuals who do not carry the HD expansion mutation.
- These two major categories can be further subdivided into six different subgroups of eligible individuals:
- Manifest/Motor-manifest HD: Carriers with clinical features that are regarded in the opinion of the investigator as diagnostic of HD.
- Pre-Manifest/-Motor-manifest HD: Carriers without clinical features regarded as diagnostic of HD.
- Genotype Unknown: This group includes a first or second degree relative (i.e., related by blood to a carrier) who has not undergone predictive testing for HD and therefore has an undetermined carrier status.
- Genotype Negative: This group includes a first or second degree relative (i.e., related by blood to a carrier) who has undergone predictive testing for HD and is known not to carry the HD expansion mutation.
- Family Control: Family members or individuals not related by blood to carriers (e.g., spouses, partners, caregivers).
- Community Controls: Individuals unrelated to HD carriers who did not grow up in a family affected by HD. Data collected from community controls will be used for generation of normative data for sub-studies.
- Participant status will be captured in the study database using 2 variables: 1) Investigator Determined Status: this will be based on clinical signs and symptoms and genotyping performed as part of medical care, and will be updated at every visit; and 2) Research Genotyping Status: this will be based on genotyping conducted as part of Enroll-HD study procedures. Based on research genotyping, participants will be reclassified under this variable from Genotype Unknown to 'Carriers' or 'Controls'. Investigators and participants will be blinded to this reclassification.
You may not qualify if:
- Individuals with choreic movement disorders in the context of a negative test for the HD gene mutation.
- For Community Controls: those individuals with a major central nervous system disorder will be excluded (e.g. stroke, Parkinson's disease, multiple sclerosis, etc.).
- Participants under 18 may be eligible to participate (if they have juvenile-onset HD).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (183)
University of Alabama
Birmingham, Alabama, 35294, United States
St. Joseph's Hospital and Medical Center
Phoenix, Arizona, 85013, United States
University of California - Irvine Medical Center
Irvine, California, 92697, United States
Loma Linda Medical Center
Loma Linda, California, 92354, United States
University of California - Los Angeles
Los Angeles, California, 90095, United States
University of California - Davis
Sacramento, California, 95817, United States
University of California - San Diego
San Diego, California, 92037, United States
University of California - San Francisco
San Francisco, California, 94158, United States
Cenexel Rocky Mountain Clinical Research, LLC
Englewood, Colorado, 80113, United States
University of Connecticut
Farmington, Connecticut, 06032, United States
Georgetown University
Washington D.C., District of Columbia, 20007, United States
University of Florida Board of Trustees
Gainesville, Florida, 32607, United States
University of Miami
Miami, Florida, 33431, United States
University of South Florida, HDSA Center of Excellence at USF
Tampa, Florida, 33612, United States
Emory University, Wesley Woods Health Center
Atlanta, Georgia, 30329, United States
Georgia Health Sciences University
Augusta, Georgia, 30912, United States
Northwestern University
Chicago, Illinois, 60611, United States
University of Chicago
Chicago, Illinois, 60637, United States
Rush University Medical Center
Chicago, Illinois, 68612, United States
University of Illinois College of Medicine at Rockford
Rockford, Illinois, 61107, United States
Indiana University
Indianapolis, Indiana, 46202, United States
University of Iowa
Iowa City, Iowa, 52245, United States
University of Kansas Medical Center
Kansas City, Kansas, 66160, United States
Hereditary Neurological Disease Center
Wichita, Kansas, 67226, United States
University of Louisville
Louisville, Kentucky, 40202, United States
University of Maryland School of Medicine
Baltimore, Maryland, 21201, United States
Johns Hopkins University
Baltimore, Maryland, 21287, United States
Boston University Medical Center
Boston, Massachusetts, 02118, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
University of Michigan
Ann Arbor, Michigan, 48105, United States
Wayne State University
Detroit, Michigan, 48201, United States
Hennepin County Medical Center
Minneapolis, Minnesota, 55415, United States
Washington University in St. Louis
St Louis, Missouri, 63110, United States
University of Nebraska Medical Center
Omaha, Nebraska, 68106, United States
Cleveland Clinic - Las Vegas
Las Vegas, Nevada, 89102, United States
Cooper University Hospital
Camden, New Jersey, 08103, United States
Rutgers, the State University of New Jersey
New Brunswick, New Jersey, 08901, United States
Albany Medical College
Albany, New York, 12208, United States
Columbia University
New York, New York, 10032, United States
University of Rochester
Rochester, New York, 14618, United States
Duke University
Durham, North Carolina, 27705, United States
Wake Forest School of Medicine
Winston-Salem, North Carolina, 27157, United States
Sanford Health
Fargo, North Dakota, 58122, United States
University of Cincinatti
Cincinnati, Ohio, 42519, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
The Ohio State University
Columbus, Ohio, 43021, United States
Oregon Health and Science University
Portland, Oregon, 97239, United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19107, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213, United States
University of South Carolina
Columbia, South Carolina, 29203, United States
University of Tennessee Health Science Center
Memphis, Tennessee, 38163, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
Baylor College of Medicine
Houston, Texas, 77030, United States
University of Texas Health Science Center
Houston, Texas, 77030, United States
University of Utah
Salt Lake City, Utah, 84108, United States
University of Vermont
Burlington, Vermont, 05401, United States
University of Virginia
Charlottesville, Virginia, 22908, United States
Virginia Commonwealth University Parkinson's and Movement Disorders Center
Henrico, Virginia, 23298, United States
Virginia Commonwealth University
Richmond, Virginia, 23233, United States
Booth Gardner Parkinson's Care Center (Evergreen Health)
Kirkland, Washington, 98034, United States
University of Washington Medical Center
Seattle, Washington, 98195, United States
University of Wisconsin - Madison
Madison, Wisconsin, 53705, United States
Instituto de Neurociencias Buenos Aires (INEBA)
Buenos Aires, Argentina
Westmead Hospital
Westmead, New South Wales, 2145, Australia
Monash University
Melbourne, Victoria, 3800, Australia
The Neurosciences Unit - North Metropolitan Hospital
Perth, Western Australia, 6010, Australia
University of Melbourne, Royal Melbourne Hospital
Parkville, 3052, Australia
Universitatsklinik Innsbruck
Innsbruck, 6020, Austria
University Hospitals Leuven
Leuven, Vlaams-Brabant, 3000, Belgium
Bruxelles - Erasme
Brussels, 1070, Belgium
Institut de Pathologie et de Génétique (IPG)
Charleroi, B-6041, Belgium
Hôpital du Beau Vallon ASBL
Saint-Servais, B-5002, Belgium
University of Calgary, Movement Disorders Program
Calgary, Alberta, T2N 4N1, Canada
University of Alberta (Glenrose)
Edmonton, Alberta, T5G 0B7, Canada
University of Alberta Hospital in Edmonton
Edmonton, Alberta, T6G 2B7, Canada
University of British Columbia
Vancouver, British Columbia, V6T 2B5, Canada
Nova Scotia Health Authority
Halifax, Nova Scotia, B3H 3A7, Canada
Centre for Movement Disorders
Markham, Ontario, L6B 1C9, Canada
The Ottawa Hospital
Ottawa, Ontario, K1Y 4E9, Canada
North York General Hospital
Toronto, Ontario, M2K 1E2, Canada
CHUM Hospital of Notre Dame
Montreal, Quebec, H2L 4M1, Canada
CETRAM
Santiago, Chile
Universidad de Antioquia, Grupo de Neurociencias
Medellín, Antioquia, 51922, Colombia
Servicios Médicos MS, Clínica de Marly
Bogotá, Cundinamarca, 110231, Colombia
University Hospital of Aarhus
Aarhus, 8000, Denmark
University Hospital of Copenhagen
Copenhagen, DK2100, Denmark
University Hospital of Odense
Odense, 5000, Denmark
Hôpitaux Universitaires de Strasbourg Hôpital de Hautepierre-Service de Neurologie
Strasbourg, Alsace Lorraine, 67098, France
CHU Amiens-Picardie
Amiens, 80054, France
CHU Angers, Centre de Référence Maladies Neurogénétiques
Angers, 49100, France
Bordeaux - Huntington Disease competencies center
Bordeaux, 33076, France
CHU Gabriel-Montpied
Clermont-Ferrand, 63003, France
Hôpital Henri Mondor, Centre d'Investigation Clinique
Créteil, 94000, France
Lille-Amiens - Huntington Disease Constituent site
Lille, 59037, France
Hôpital La Timone
Marseille, 13005, France
CHU Montpellier
Montpellier, 34295, France
Institut du Cerveau et de la Moelle Epinière
Paris, 75646, France
Hôpital Purpan, Centre d'Investigation Clinique
Toulouse, 31059, France
University Hospital Aachen
Aachen, 52074, Germany
University of Berlin
Berlin, 10117, Germany
St. Josef und St. Elisabeth Hospital
Bochum, 44791, Germany
University Hospital Carl Gustav Carus Dresden
Dresden, 1307, Germany
University Hospital Erlangen
Erlangen, 91054, Germany
University Medical Center Freiburg
Freiburg im Breisgau, 79106, Germany
Paracelsus Elena Klinik Kassel
Kassel, 34128, Germany
University Hospital Schleswig-Holstein
Lübeck, 23538, Germany
University Hospital Giessen and Marburg
Marburg, 25043, Germany
Technical University of Munich
Munich, 81675, Germany
George-Huntington-Institut GmbH
Münster, 48149, Germany
kbo-Isar-Amper-Klinikum Taufkirchen (Vils)
Taufkirchen, 84416, Germany
University Hopsital of Ulm
Ulm, 89081, Germany
University Hospital of Wuerzburg
Würzburg, 97080, Germany
Beaumont Hospital
Dublin, Republic of Ireland, Ireland
Fondazione IRCCS Istituto Neurologico Carlo Besta - Genetics
Milan, MI, 20133, Italy
Bari Policlinico General Hospital
Bari, 70124, Italy
IRCCS Istituto delle Scienze Neurologiche di Bologna
Bologna, 40139, Italy
Università degli Studi di Genova (DINOGMI)
Genoa, 16132, Italy
Fondazione IRCCS Istituto Neurologico Carlo Besta - Neurology
Milan, 20133, Italy
University of Naples
Napoli, I-80131, Italy
Università Cattolica del Sacro Cuore
Rome, 00168, Italy
Lega Italiana Ricerca Huntington (LIRH)
Rome, 00185, Italy
Azienda Ospedaliera Sant'Andrea
Rome, 00189, Italy
University Medical Center Groningen
Groningen, 9700RB, Netherlands
Leiden University Medical Centre
Leiden, 2300 RC, Netherlands
Clinical Trial Center Maastricht B.V.
Maastricht, 6202 AZ, Netherlands
Auckland City Hospital
Auckland, 1142, New Zealand
New Zealand Brain Research Institute at University of Otago
Christchurch, 8011, New Zealand
Wellington Hospital
Wellington, 6021, New Zealand
Copernicus Podmiotem Leczniczym sp. z o.o.
Gdansk, 80-462, Poland
Krakowska Akademia Neurologii Sp. z o.o
Katowice, 40-588, Poland
Krakow - Krakowska Akademia Neurologii
Krakow, 31-505, Poland
Solumed Centrum Medyczne
Poznan, 60-529, Poland
Medical University of Warsaw
Warsaw, 02-097, Poland
Institute of Psychiatry and Neurology, Warsaw
Warsaw, 02-957, Poland
Hospital Prof Doutor Fernando Fonseca
Amadora, 2720-276, Portugal
Hospital Universitário de Coimbra
Coimbra, 3000-075, Portugal
Central Lisbon Hospital
Lisbon, 1169-050, Portugal
Hospital de Santa Maria / Instituto de Medicina Molecular
Lisbon, 1649-035, Portugal
Hospital Universitário de São João
Porto, 4200-319, Portugal
Hospital Infanta Cristina, Badajoz
Badajoz, 06080, Spain
Hospital de Cruces
Barakaldo, 08036, Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, 08025, Spain
Hospital Mare de Déu de la Mercè
Barcelona, 08035, Spain
Fundacion Clinic per a La Recerca Biomèdica
Barcelona, 08036, Spain
Hospital Universitari de Bellvitge
Barcelona, 08907, Spain
Hospital Universitario de Burgos
Burgos, 09006, Spain
Hospital Universitario Ramón y Cajal
Madrid, 28034, Spain
Fundación Jiménez Díaz
Madrid, 28040, Spain
Hospital Son Espases
Palma de Mallorca, 07120, Spain
Complejo Hospitalario de Navarra
Pamplona, 31008, Spain
Fundacion Hospital Universitario La Fe
Valencia, 46970, Spain
Siloah AG
Gümligen, 3073, Switzerland
University Hospital Zurich
Zurich, 08091, Switzerland
Royal Devon and Exeter NHS Foundation Trust
Exeter, Devon, EX25DW, United Kingdom
Leicestershire Partnership
Narborough, Leicestershire, LE19 4SL, United Kingdom
North Bristol NHS Trust
Bristol, UK, BS10 5NB, United Kingdom
Fife Health Board
Kirkcaldy, UK, KY1 2ND, United Kingdom
Betsi Cadwaladr University Health Board
Wrexham, UK, LL13 7TD, United Kingdom
University of Aberdeen
Aberdeen, AB25 2ZA, United Kingdom
Birmingham and Solihull Mental Health NHS Foundation Trust
Birmingham, B15 2FG, United Kingdom
University of Cambridge
Cambridge, CB2 0PY, United Kingdom
Cardiff University
Cardiff, CF24 4HQ, United Kingdom
Tayside Health Board
Dundee, DD1 9SY, United Kingdom
Lothian Health Board
Edinburgh, EH4 2XU, United Kingdom
Greater Glasgow Health Board
Glasgow, G51 4TF, United Kingdom
Ayrshire Central Hospital
Kilmarnock, KA2 OBB, United Kingdom
NHS Forth Valley
Larbert, FK5 4WR, United Kingdom
Leeds Teaching Hospitals
Leeds, LS7 4SA, United Kingdom
The Walton Centre
Liverpool, L9 7LJ, United Kingdom
Guy's and St. Thomas's NHS Foundation Trust
London, SE1 9RT, United Kingdom
St. George's Hospital
London, SW17 0RE, United Kingdom
University College of London
London, WC1B SEH, United Kingdom
Central Manchester University Hospitals NHS Foundation Trust
Manchester, M13 9WL, United Kingdom
Northumberland, Tyne & Wear NHS Foundation Trust of St. Nicholas Hospital
Newcastle upon Tyne, NE3 3XT, United Kingdom
St. Andrews Healthcare
Northampton, NN1 5DG, United Kingdom
Oxford Radcliffe Hospitals
Oxford, OX3 9DU, United Kingdom
Plymouth Hospitals NHS Trust
Plymouth, PL6 8BX, United Kingdom
Poole Hospital
Poole, BH15 2JB, United Kingdom
Royal Berkshire NHS Foundation Trust
Reading, RG1 5AN, United Kingdom
Sheffield Children's NHS Foundation Trust
Sheffield, S10 2TH, United Kingdom
University Hospital Southampton
Southampton, SO16 6YD, United Kingdom
North Staffordshire Combined Healthcare NHS Trust
Stoke-on-Trent, ST4 8HH, United Kingdom
Avon and Wiltshire Mental Health Partnership
Swindon, SN3 6BW, United Kingdom
Related Publications (3)
Gray SM, Dai J, Smith AC, Beckley JT, Rahmati N, Lewis MC, Quirk MC. Changes in 24(S)-Hydroxycholesterol Are Associated with Cognitive Performance in Early Huntington's Disease: Data from the TRACK and ENROLL HD Cohorts. J Huntingtons Dis. 2024 Nov;13(4):449-465. doi: 10.3233/JHD-240030.
PMID: 39269850DERIVEDLangbehn DR, Sathe SS, Loy C, Sampaio C, Mccusker EA. A Phenotypic Atlas for Huntington Disease Based on Data From the Enroll-HD Cohort Study. Neurol Genet. 2023 Nov 28;9(6):e200111. doi: 10.1212/NXG.0000000000200111. eCollection 2023 Dec.
PMID: 38035176DERIVEDLandwehrmeyer GB, Fitzer-Attas CJ, Giuliano JD, Goncalves N, Anderson KE, Cardoso F, Ferreira JJ, Mestre TA, Stout JC, Sampaio C. Data Analytics from Enroll-HD, a Global Clinical Research Platform for Huntington's Disease. Mov Disord Clin Pract. 2016 Jun 22;4(2):212-224. doi: 10.1002/mdc3.12388. eCollection 2017 Mar-Apr.
PMID: 30363395DERIVED
Biospecimen
Blood
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Bernhard G Landwehrmeyer, MD, PhD
University of Ulm
- STUDY DIRECTOR
Jamie Levey
CHDI Foundation, Inc.
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Target Duration
- 1 Year
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 6, 2012
First Posted
April 10, 2012
Study Start
July 1, 2012
Primary Completion (Estimated)
January 1, 2062
Study Completion (Estimated)
January 1, 2062
Last Updated
February 28, 2024
Record last verified: 2024-02