Collects spinal fluid and blood samples from people with Huntington's disease

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for people at different stages of Huntington's disease, and also control volunteers, to give a spinal fluid (CSF) sample and a blood plasma sample for research.

Age

18-75 years for controls, early or late premanifest HD and incomplete penetrance HD; 21-75 years for early, moderate or advanced manifest HD; 11 years or older for juvenile HD.

Sex

All sexes can join.

Disease stage

People at different stages of Huntington's disease (HD), from premanifest to advanced; controls can also join.

Earlier treatment

No drug trial within 30 days, and no antiplatelet or anticoagulant therapy within 14 days, before a sampling visit.

Biomarker or test result

Everyone except family and community controls must have had a genetic test for HD.

Main reasons for not taking part

• Drug trial within 30 days of any sampling visit
• Changes in medication used to treat HD within 30 days
• Antiplatelet or anticoagulant therapy within 14 days
• Clotting or bruising disorder, needle phobia, headache, or spinal surgery or deformity
• Positive urine pregnancy test for women who could become pregnant

The registry criteria, word for word

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

• Are you between 11 and 75 years old?YesNo

What the trial wants to find out

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.

The 8 groups in the trial

• 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).