HDClarity: a Multi-site Cerebrospinal Fluid Collection Initiative to Facilitate Therapeutic Development for Huntington's Disease
Status: Recruiting
Location: See all (39) locations...
Study Type: Observational
SUMMARY
HDClarity will seek at least 2500 research participants at different stages of Huntington's disease (HD). The primary objective is to collect a high quality CSF sample for evaluation of biomarkers and pathways that will enable the development of novel treatments for HD. The secondary objective is to generate a high quality plasma sample collection matching the CSF collections, which will also be used to evaluate biomarkers and pathways of relevance to HD research and development.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 11
Maximum Age: 75
Healthy Volunteers: t
View:
• Age (18-75 years controls, early/late premanifest HD and incomplete penetrance HD, 21-75 years early/moderate/advanced manifest HD, ≥11 years juvenile HD)
• Enroll HD participant
• Capable of consenting or have a legal representative (parent/guardian for juveniles)
• Capable of complying with study procedures
• All participants other than family and community controls must have had a genetic test for HD
Locations
United States
Colorado
Cenexel
RECRUITING
Englewood
Washington, D.c.
Georgetown University
RECRUITING
Washington D.c.
Maryland
John Hopkins University
RECRUITING
Baltimore
North Carolina
Wake Forest University
ACTIVE_NOT_RECRUITING
Winston-salem
Tennessee
Vanderbilt University Medical Center
RECRUITING
Nashville
Texas
University of Texas Health Science Center
RECRUITING
Houston
Other Locations
Canada
The Ottawa Hospital
RECRUITING
Ottawa
Centre for Movement Disorders
COMPLETED
Toronto
North York General Hospital
RECRUITING
Toronto
University of British Columbia, The Centre for Huntingtons Disease
ACTIVE_NOT_RECRUITING
Vancouver
France
Centre Hospitalier Universitaire d'Angers
RECRUITING
Angers
Le Centre Hospitalier Universitaire de Bordeaux
RECRUITING
Bordeaux
Germany
St Josef And Elisabeth Hospital
RECRUITING
Bochum
Dresden University
RECRUITING
Dresden
University Hospital of Erlangen
RECRUITING
Erlangen
George Huntington Institute
RECRUITING
Münster
Kbo-Isar-Amper-Klinikum Taufkirchen (Vils)
RECRUITING
Taufkirchen
University Hospital Ulm
RECRUITING
Ulm
Italy
Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
ACTIVE_NOT_RECRUITING
Milan
Lega Italiana Ricera Huntington
RECRUITING
Rome
New Zealand
NZ Brain Research Institute
RECRUITING
Christchurch
The University of Auckland
RECRUITING
Grafton
Poland
Institute of Psychiatry and Neurology
ACTIVE_NOT_RECRUITING
Warsaw
Spain
Hospital de Sant Pau
RECRUITING
Barcelona
Cruces University Hospital
RECRUITING
Bilbao
Ramón y Cajal Universitary Hospital
RECRUITING
Madrid
United Kingdom
Birmingham Huntingtons Disease Clinic
RECRUITING
Birmingham
North Bristol NHS Trust
ACTIVE_NOT_RECRUITING
Bristol
Cambridge University Hospitals NHS Foundation Trust
RECRUITING
Cambridge
Cardiff University
RECRUITING
Cardiff
Royal Devon & Exeter NHS Foundation Trust
RECRUITING
Exeter
Glasgow Clinical Research Facility
RECRUITING
Glasgow
Fife Health Board - Whyteman's Brae Hospital
ACTIVE_NOT_RECRUITING
Kirkcaldy
Leeds Teaching Hospital Trust
RECRUITING
Leeds
The Walton Centre NHS Foundation Trust
RECRUITING
Liverpool
St George's University Of London
RECRUITING
London
University College London Hospitals NHS Foundation Trust
RECRUITING
London
Oxford University Hospitals NHS Foundation Trust
RECRUITING
Oxford
University Hospitals Plymouth NHS Trust
RECRUITING
Plymouth
Contact Information
Primary
Katarzyna Schubert, PhD
hdclarity-cc@enroll-hd.org
Backup
Gail Owen, PhD
g.owen@ucl.ac.uk
+44 1273 640 688
Time Frame
Start Date: 2017-01-01
Estimated Completion Date: 2027-04-30
Participants
Target number of participants: 2500
Treatments
Early Pre-manifest HD
Participants eligible are persons who meet the following criteria:~1. Are 18-75 years of age, inclusive, at the time of consent; and~2. Do not have clinical diagnostic motor features of HD, defined as Unified Huntington's Disease Rating Scale (UHDRS) Diagnostic Confidence Score \< 4; and~3. Have CAG expansion ≥ 40; and~4. Have burden of pathology score, computed as (CAG - 35.5) × age, \< 250
Late Pre-manifest HD
Participants eligible are persons who meet the following criteria:~1. Are 18-75 years of age, inclusive, at the time of consent; and~2. Do not have clinical diagnostic motor features of HD, defined as Unified Huntington's Disease Rating Scale (UHDRS) Diagnostic Confidence Score \< 4; and~3. Have CAG expansion ≥ 40; and~4. Have burden of pathology score, computed as (CAG - 35.5) x age, ≥ 250
Early Manifest HD
Participants eligible are persons who meet the following criteria:~1. Are 21-75 years of age, inclusive, at the time of consent; and~2. Have clinical diagnostic motor features of HD, defined as UHDRS Diagnostic Confidence Score = 4; and~3. Have CAG expansion ≥ 40; and~4. Have Stage I or Stage II HD, defined as UHDRS Total Functional Capacity (TFC) scores between 7 and 13 inclusive
Moderate Manifest HD
Participants eligible are persons who meet the following criteria:~1. Are 21-75 years of age, inclusive, at the time of consent; and~2. Have clinical diagnostic motor features of HD, defined as UHDRS Diagnostic Confidence Score = 4; and~3. Have CAG expansion ≥ 40; and~4. Have Stage III HD, defined as UHDRS TFC scores between 3 and 6, inclusive
Advanced Manifest HD
Participants eligible are persons who meet the following criteria:~1. Are 21-75 years of age, inclusive, at the time of consent; and~2. Have clinical diagnostic motor features of HD, defined as UHDRS Diagnostic Confidence Score = 4; and~3. Have CAG expansion ≥ 40; and~4. Have Stage IV HD, defined as UHDRS TFC scores between 0 and 2, inclusive
Incomplete Penetrance HD
Participants eligible are persons who meet the following criteria:~1. Are 18-75 years of age, inclusive, at the time of consent; and~2. Have CAG expansion of 36-39
Juvenile Manifest HD
Participants eligible are persons who meet the following criteria:~1. Are ≥11 years of age at the time of consent; and~2. Have clinical diagnostic features of juvenile HD, defined as UHDRS Diagnostic Confidence Score = 4 aged ≤20 years; and~3. Have CAG expansion ≥ 40
Healthy Control
Participants eligible are persons who meet the following criteria:~1. Are 18-75 years of age, inclusive, at the time of consent; and~2. Have no known family history of HD; or~3. Have known family history of HD but have been tested for the huntingtin gene CAG expansion and are not at genetic risk for HD (CAG \< 36).
Authors
Related Therapeutic Areas
Sponsors
Leads: University College, London
Collaborators: CHDI Foundation, Inc.