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

Conditions

• Huntington's Disease

Eligibility Criteria

Sex

ALL

Age

11 Years - 75 Years

Healthy Volunteers

Accepted

Study Details

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.

Key Dates

Start date

Jan 1, 2017

Status verified

Apr 2026

Primary completion

Apr 30, 2027

Study Design

Enrollment

2,500 participants (estimated)

Arms

• Arm: 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
• Arm: 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
• Arm: 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
• Arm: 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
• Arm: 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
• Arm: 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
• Arm: 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
• Arm: 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).

Primary Outcome Measure

The primary objective of this study is: [ Time Frame: years N/A ]

Central Contacts

• Katarzyna Schubert, PhD
  [email protected]
• Gail Owen, PhD
  +44 1273 640 688
  [email protected]

Locations (6)

Find similar trials in Englewood, CO

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