HDClarity: a Multi-site Cerebrospinal Fluid Collection Initiative to Facilitate Therapeutic Development for Huntington's Disease
HDClarity
1 other identifier
observational
2,500
10 countries
40
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
40 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
July 26, 2016
CompletedFirst Posted
Study publicly available on registry
August 4, 2016
CompletedStudy Start
First participant enrolled
January 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2027
ExpectedApril 27, 2026
April 1, 2026
10.3 years
July 26, 2016
April 24, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
The primary objective of this study is:
To generate a high quality CSF sample collection for evaluation of biomarkers and pathways that will enable the development of novel treatments for HD.
years N/A
Secondary Outcomes (1)
The secondary objectives of this study are:
years N/A
Study Arms (8)
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).
Eligibility Criteria
Participants across 8 clinical cohorts will be enrolled at multiple sites up to an estimated minimum of 2500 participants or until the study is terminated by either the Funding Source or Sponsor
You may qualify if:
- 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
You may not qualify if:
- Drug trial within 30 days of any sampling visit
- Changes in medication (antidepressant, psychoactive, psychotropic or other medications or nutraceuticals used to treat HD within 30 days)
- Antiplatelet or anticoagulant therapy within 14 days
- Significant comorbidity
- Needle phobia, headache, spinal surgery / deformity
- Clotting or bruising disorder
- Screening blood test abnormalities \>10% outside normal range
- Drug / alcohol abuse
- Positive urine pregnancy test at any screening or sampling visit for females of childbearing potential
- Predictable non compliance or unwillingness
- Serious adverse event related to HDClarity study procedures or any lumbar puncture procedure performed for any reason in the previous 30 days
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University College, Londonlead
- CHDI Foundation, Inc.collaborator
Study Sites (40)
Cenexel
Englewood, Colorado, United States
Georgetown University
Washington D.C., District of Columbia, 20057, United States
John Hopkins University
Baltimore, Maryland, 21287, United States
Wake Forest University
Winston-Salem, North Carolina, 27109, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37212, United States
University of Texas Health Science Center
Houston, Texas, 77030, United States
University of British Columbia, The Centre for Huntingtons Disease
Vancouver, British Columbia, V6T 2B5, Canada
The Ottawa Hospital
Ottawa, Ontario, K1Y 4E9, Canada
North York General Hospital
Toronto, Ontario, M2K 1E1, Canada
Centre for Movement Disorders
Toronto, Ontario, M3B 2S7, Canada
Centre Hospitalier Universitaire d'Angers
Angers, 49000, France
Le Centre Hospitalier Universitaire de Bordeaux
Bordeaux, 33076, France
University Hospital Ulm
Ulm, Baden-Wurttemberg, 89081, Germany
Dresden University
Dresden, Saxony, 01307, Germany
St Josef And Elisabeth Hospital
Bochum, 44791, Germany
University Hospital of Erlangen
Erlangen, 91054, Germany
George Huntington Institute
Münster, 48149, Germany
Kbo-Isar-Amper-Klinikum Taufkirchen (Vils)
Taufkirchen, 84416, Germany
Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
Milan, 20133, Italy
Lega Italiana Ricera Huntington
Rome, 00185, Italy
The University of Auckland
Grafton, Auckland, 1023, New Zealand
NZ Brain Research Institute
Christchurch, Canterbury, 8011, New Zealand
Institute of Psychiatry and Neurology
Warsaw, 02-957, Poland
Gulbenkian Institute of Molecular Medicine
Lisbon, 1649-028, Portugal
Cruces University Hospital
Bilbao, Biscay, 48903, Spain
Hospital de Sant Pau
Barcelona, 08041, Spain
Ramón y Cajal Universitary Hospital
Madrid, 28034, Spain
Royal Devon & Exeter NHS Foundation Trust
Exeter, Devon, EX2 5DW, United Kingdom
Glasgow Clinical Research Facility
Glasgow, Scotland, G51 4TF, United Kingdom
Birmingham Huntingtons Disease Clinic
Birmingham, West Midlands, B15 2 FG, United Kingdom
North Bristol NHS Trust
Bristol, BS10 5NB, United Kingdom
Cambridge University Hospitals NHS Foundation Trust
Cambridge, CB2 0PY, United Kingdom
Cardiff University
Cardiff, CF24 4HQ, United Kingdom
Fife Health Board - Whyteman's Brae Hospital
Kirkcaldy, KY1 2ND, United Kingdom
Leeds Teaching Hospital Trust
Leeds, LS7 4SA, United Kingdom
The Walton Centre NHS Foundation Trust
Liverpool, L9 7LJ, United Kingdom
University College London Hospitals NHS Foundation Trust
London, NW1 2PG, United Kingdom
St George's University Of London
London, SW17 0RE, United Kingdom
Oxford University Hospitals NHS Foundation Trust
Oxford, OX3 9DU, United Kingdom
University Hospitals Plymouth NHS Trust
Plymouth, PL6 5FP, United Kingdom
Related Links
Biospecimen
CSF, serum, plasma (participant DNA available via Enroll-HD)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Edward J Wild, MA, MB BChir, MRCP, PhD
University College, London
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr
Study Record Dates
First Submitted
July 26, 2016
First Posted
August 4, 2016
Study Start
January 1, 2017
Primary Completion (Estimated)
April 30, 2027
Last Updated
April 27, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
The cerebrospinal fluid (CSF) and plasma samples collected in this study will be the basis of future biomarker analysis studies. A Scientific Advisory Committee which will decide how the samples will be analysed.