A study following patients with Huntington's Disease over time

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Study coordinator
Name - Clinical Trials Office
Email - hs-clinicaltrials@ucdavis.edu
Phone - (855)823-1660

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"Help us learn more about Huntington's Disease"
Age: 18 and older
Gender:
Any
Healthy Volunteers: No
Keywords: Huntington's, huntington's disease
Type: Prospective
Target:
100 Participants
Investigator:
Description
We hope to learn more about Huntington’s Disease (HD) and to try to find new treatments for the disease. This research study will collect clinical information about you and your health. We will also collect biological samples, such as blood and DNA (the genetic material in your blood). People from many countries contribute to Enroll-HD. Because of the size of the study, we hope to get answers to many research questions faster than in the past.

You are being asked to take part in this study because you have HD or are from an HD family. You may also be in the study as a “community control”. A community control is a person who does not carry the HD genetic mutation that causes Huntington’s disease and is not part of an HD family.
This study requires

This study is called: Enroll-HD. It is a continuation of the COHORT study (Cooperative Huntington Observational Research Trial). It is an ongoing longitudinal study. That means we will ask you to undergo the research procedures about once a year for as long as you are willing to participate.

Enroll-HD has several parts, five of which are core parts of the research study and others which are optional. If you consent to participate in Enroll-HD we will: 1. Assign/confirm a 9-digit unique identifier (HDID) 2. Conduct a clinical evaluation of your current medical status and wellbeing. 3. Collect a sample of your blood to study your DNA. 4. If you participated in the COHORT study, include any data and samples collected from you in that study in the database along with the data from the Enroll-HD study. 5. Store the data and biological materials we collect from you (including any data and samples from COHORT) in a secure place and make them available for future research.

For the optional parts, we will also: 1. Collect information about your family history. 2. Collect other biological samples from you. 3. Link clinical information about you collected in research studies other than COHORT to the clinical information about you collected in this study. 4. Offer you the opportunity to participate in sub-studies. 5. Contact you between study visits to provide information about future HD research studies or find out information about your health status or wellbeing.

Who can participate

Inclusion criteria:

  • Carriers: This group comprises the primary study population and consists of individuals who carry the HD gene expansion mutation.
  • Controls: This group comprises the comparator study population and consists of individuals who do not carry the HD expansion mutation. These two major categories can be further subdivided into six different subgroups of eligible individuals:
  • Manifest/Motor-manifest HD: Carriers with clinical features that are regarded in the opinion of the investigator as diagnostic of HD.
  • Pre-Manifest/-Motor-manifest HD: Carriers without clinical features regarded as diagnostic of HD.
  • Genotype Unknown: This group includes a first or second degree relative, i.e., related by blood to a carrier, who has not undergone predictive testing for HD and therefore has an undetermined carrier status.
  • Genotype Negative: This group includes a first or second degree relative, i.e., related by blood to a carrier, who has undergone predictive testing for HD and is known not to carry the HD expansion mutation.
  • Family Control: Family members or individuals not related by blood to carriers (e.g., spouses, partners, caregivers).
  • Community Controls: Individuals unrelated to HD carriers who did not grow up in a family affected by HD. Data collected from community controls will be used for generation of normative data for sub-studies. Participant status will be captured in the study database using 2 variables: 1) Investigator Determined Status: this will be based on clinical signs and symptoms and genotyping performed as part of medical care, and will be updated at every visit and 2) Research Genotyping Status: this will be based on genotyping conducted as part of Enroll-HD study procedures. Based on research genotyping, participants will be reclassified under this variable from Genotype Unknown to 'Carriers' or 'Controls'. Investigators and participants will be blinded to this reclassification.

Exclusion criteria:

  • Individuals who do not meet inclusion criteria,
  • Individuals with choreic movement disorders in the context of a negative test for the HD gene mutation.
  • For Community Controls: those individuals with a major central nervous system disorder will be excluded (e.g. stroke, Parkinson disease, Multiple Sclerosis, etc.). Participants under 18 may be eligible to participate (if they have juvenile-onset HD).
Benefits and risks of participating
BENEFITS:

We can promise no benefits to you from participating in this research.


RISKS:

Your physician will review all the risks of this study with you.
Compensation
We will reimburse you for the cost of travel as follows.
If you travel:
• Less than 25 miles; you receive $25.00
• 25-50 Miles; you receive $50.00
• Greater than 50 miles; you receive $75.00
Resources
Schedule
Study duration and period
As long as you are willing to participate.
Recruitment period
From Nov. 6, 2012 to Sept. 17, 2018
Location
UC Davis Department of Neurology
3160 Folsom Boulevard
Sacramento, CA 95816
Contact
Clinical Trials Office
Research Topic
Conditions:
  • Huntington's Disease

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