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Huntington's Disease 123

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ClinicalTrials.gov Identifier: NCT03434548
Recruitment Status : Not yet recruiting
First Posted : February 15, 2018
Last Update Posted : September 18, 2018
Sponsor:
Information provided by (Responsible Party):
King's College London

Tracking Information
First Submitted Date February 7, 2018
First Posted Date February 15, 2018
Last Update Posted Date September 18, 2018
Estimated Study Start Date April 1, 2019
Estimated Primary Completion Date March 31, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 13, 2018)
Change in binding profile of four discrete molecular PET markers [ Time Frame: From study enrolment up to 24 months ]
Determine whether selected PET markers could be used as markers of HD disease progression and treatment response in therapeutic trials.
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03434548 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Huntington's Disease 123
Official Title Huntington's Disease 123
Brief Summary The primary goal of the program is to derive biomarkers that could be further developed to measure the efficacy of novel pharmacological treatments for HD.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Other
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Analysis will be performed to confirm the size of the CAG expansion mutation within the HD gene for all HDGEC participants, for research purposes only.
Sampling Method Probability Sample
Study Population Healthy controls (HCs) and Huntington's Disease Gene Expansion Carriers (HDGECs).
Condition Huntington Disease
Intervention Not Provided
Study Groups/Cohorts
  • Cohort 1
    Healthy Controls
  • Cohort 2
    Huntington's Disease Gene Expansion Carriers (HDGECs: premanifest near-onset, peri-manifest, and manifest), and Healthy Controls
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Not yet recruiting
Estimated Enrollment
 (submitted: February 13, 2018)
150
Original Estimated Enrollment Same as current
Estimated Study Completion Date March 31, 2024
Estimated Primary Completion Date March 31, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Must be capable of giving informed consent
  • Must be willing to comply with adequate contraceptive measures
  • Must be considered by the Investigator to be in good heath (excluding disease under study)

Exclusion Criteria:

  • Individuals who do not meet inclusion criteria
  • Known intracranial comorbidities (i.e. stroke, haemorrhage, space-occupying lesions etc.)
  • The presence or history of other neurological or primary psychiatric disorders secondary to HD
  • Pregnancy
  • Breastfeeding
  • Contraindication to MRI (e.g. presence of metal devices, metal deposited in the body)
Sex/Gender
Sexes Eligible for Study: All
Ages 21 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Chloe Farrell, PhD 00442078485452 chloe.farrell@kcl.ac.uk
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT03434548
Other Study ID Numbers HD123
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party King's College London
Study Sponsor King's College London
Collaborators Not Provided
Investigators
Principal Investigator: Chloe Farrell, PhD King's College London
PRS Account King's College London
Verification Date February 2018