RECRUITINGOBSERVATIONAL
HDClarity: a Multi-site Cerebrospinal Fluid Collection Initiative to Facilitate Therapeutic Development for Huntington's Disease
About This Trial
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.
Who May Be Eligible (Plain English)
Who May Qualify:
- 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
Who Should NOT Join This Trial:
- 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
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
Locations (20)
Cenexel
Englewood, Colorado, United States
Georgetown University
Washington D.C., District of Columbia, United States
John Hopkins University
Baltimore, Maryland, United States
Wake Forest University
Winston-Salem, North Carolina, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
University of Texas Health Science Center
Houston, Texas, United States
University of British Columbia, The Centre for Huntingtons Disease
Vancouver, British Columbia, Canada
The Ottawa Hospital
Ottawa, Ontario, Canada
North York General Hospital
Toronto, Ontario, Canada
Centre for Movement Disorders
Toronto, Ontario, Canada
Centre Hospitalier Universitaire d'Angers
Angers, France
Le Centre Hospitalier Universitaire de Bordeaux
Bordeaux, France
University Hospital Ulm
Ulm, Baden-Wurttemberg, Germany
Dresden University
Dresden, Saxony, Germany
St Josef And Elisabeth Hospital
Bochum, Germany
University Hospital of Erlangen
Erlangen, Germany
George Huntington Institute
Münster, Germany
Kbo-Isar-Amper-Klinikum Taufkirchen (Vils)
Taufkirchen, Germany
Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
Milan, Italy
Lega Italiana Ricera Huntington
Rome, Italy