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iMarkHD: In Vivo Longitudinal Imaging of HD Pathology

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

Brief Summary:
iMarkHD is an innovative clinical imaging study and collaboration between the CHDI Foundation and Professor Marios Politis from King's College London (KCL) designed to assess longitudinal change in Huntington's disease (HD) pathology with positron emission tomography (PET) molecular and multi-modal magnetic resonance (MR) imaging, and clinical observation for up to three years.

Condition or disease
Huntington Disease

Detailed Description:
The primary goal of the program is to derive candidate pharmacodynamics biomarkers that could be further developed to measure the efficacy of novel pharmacological treatments for HD.

Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Case-Control
Time Perspective: Other
Official Title: iMarkHD: Longitudinal Adaptive Study of Molecular Pathology and Neuronal Networks in Huntington's Disease Gene Expansion Carriers (HDGECs) and Healthy Controls Using Positron Emission Tomography and Multi-modal Magnetic Resonance Imaging
Estimated Study Start Date : April 1, 2018
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 have adequate visual and auditory acuity to complete psychological testing
  • Must be capable of giving informed consent
  • Must be willing to comply with adequate contraceptive measures
  • Systolic blood pressure of 85-160 mmHg
  • Diastolic blood pressure of 50-100 mmHg
  • Heart rate of 45-110 bpm
  • Must be considered by the Investigator to be in good heath (excluding disease under study)

Exclusion Criteria:

  • Known intracranial comorbidities (i.e. stroke, haemorrhage, space-occupying lesions etc.)
  • Participants using any medications with known actions on CB1R, PDE-10A, 5-HT2AR, H3R
  • 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)
  • History of alcoholism or substance abuse within three years prior to study entry
  • Failure of drug screen for substances of abuse
  • History of cancer
  • Claustrophobia
  • Significant back pain
  • Contraindication for arterial cannulation
  • Inability to communicate or cooperate for any reason
  • Participants who are currently enrolled in or participated in clinical trials testing the efficacy of novel therapeutics with action on the specific PET targets being tested within three months of screening
  • Any concurrent conditions that could interfere with the safety and/or tolerability measurements.

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: Marios Politis, MD MSc PhD 00442078485452 marios.politis@kcl.ac.uk

Sponsors and Collaborators
King's College London
CHDI Foundation, Inc.
Investigators
Principal Investigator: Marios Politis, MD MSc PhD King's College London

Responsible Party: King's College London
ClinicalTrials.gov Identifier: NCT03434548     History of Changes
Other Study ID Numbers: C-000917-1
First Posted: February 15, 2018    Key Record Dates
Last Update Posted: February 15, 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