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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

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.

Condition or disease
Huntington Disease

Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Case-Control
Time Perspective: Other
Official Title: Huntington's Disease 123
Estimated Study Start Date : April 1, 2019
Estimated Primary Completion Date : March 31, 2024
Estimated Study Completion Date : March 31, 2024

Resource links provided by the National Library of Medicine


Group/Cohort
Cohort 1
Healthy Controls
Cohort 2
Huntington's Disease Gene Expansion Carriers (HDGECs: premanifest near-onset, peri-manifest, and manifest), and Healthy Controls



Primary Outcome Measures :
  1. 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.


Biospecimen Retention:   Samples With DNA
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.


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Ages Eligible for Study:   21 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Healthy controls (HCs) and Huntington's Disease Gene Expansion Carriers (HDGECs).
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03434548


Contacts
Contact: Chloe Farrell, PhD 00442078485452 chloe.farrell@kcl.ac.uk

Sponsors and Collaborators
King's College London
Investigators
Principal Investigator: Chloe Farrell, PhD King's College London

Responsible Party: King's College London
ClinicalTrials.gov Identifier: NCT03434548     History of Changes
Other Study ID Numbers: HD123
First Posted: February 15, 2018    Key Record Dates
Last Update Posted: September 18, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Chorea
Huntington Disease
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Dementia
Dyskinesias
Movement Disorders
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Genetic Diseases, Inborn
Cognition Disorders
Neurocognitive Disorders
Mental Disorders