HDClarity: a Multi-site Cerebrospinal Fluid Collection Initiative to Facilitate Therapeutic Development for Huntington's Disease
University College, London
2,500 participants
Jan 1, 2017
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
Inclusion Criteria5
- 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 Criteria11
- 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
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Locations(40)
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NCT02855476