HDClarity: a Multi-site Cerebrospinal Fluid Collection Initiative to Facilitate Therapeutic Development for Huntington's Disease

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age11-75
SponsorUniversity College, London

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial population

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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

2,500 Participants
are grouped into 8 trial groups

8

Trial groups

See each trial group below.

Group A: Early Pre-manifest HD
Group B: Late Pre-manifest HD
Group C: Early Manifest HD
Group D: Moderate Manifest HD
Group E: Advanced Manifest HD
Group F: Incomplete Penetrance HD
Group G: Juvenile Manifest HD
Group H: Healthy Control

Trial outcomes

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.

Time frame
years N/A

Secondary outcomes

1

The secondary objectives of this study are:

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. To collect phenotypic and clinical data for each participant.

Time frame
years N/A

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University College, London

Lead sponsor

CHDI Foundation, Inc.

Collaborator