Actively Recruiting

Age: 21Years - 75Years
All Genders
Healthy Volunteers
NCT03434548

IMarkHD: in Vivo Longitudinal Imaging of HD Pathology

Led by King's College London · Updated on 2025-03-05

113

Participants Needed

1

Research Sites

310 weeks

Total Duration

On this page

Sponsors

K

King's College London

Lead Sponsor

C

CHDI Foundation, Inc.

Collaborating Sponsor

AI-Summary

What this Trial Is About

iMarkHD is an adaptive, longitudinal positron emission tomography (PET) and magnetic resonance (MR) imaging study in Huntington's disease (HD) that aims to assess abnormal molecular, functional, and structural changes in participants' brains, ranging from several years before symptom onset to the advanced symptom stage. The study will be conducted over a three (3) year period (Baseline, Year-1, and Year-2).

CONDITIONS

Official Title

IMarkHD: in Vivo Longitudinal Imaging of HD Pathology

Who Can Participate

Age: 21Years - 75Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 21 to 75 years, male or female
  • Adequate vision and hearing to complete psychological tests
  • Able to give informed consent
  • Willing to use effective contraception (for Cohort 2)
  • Vital signs within specified ranges
  • Generally in good health without significant diseases
  • Physically and psychologically able to travel to study centers in London, UK
  • For PwHD without symptoms: Huntington's disease gene expansion with e40 CAG repeats and specific clinical scores
  • For PwHD with early symptoms: Huntington's disease gene expansion with e40 CAG repeats and defined clinical criteria
  • For PwHD with late symptoms: Huntington's disease gene expansion with e40 CAG repeats and defined clinical criteria
  • Healthy controls matched in age and sex, with no genetic risk for HD
Not Eligible

You will not qualify if you...

  • History or presence of other neurological disorders affecting brain imaging or examination
  • Primary psychiatric disorders unrelated to Huntington's disease
  • Use of medications affecting PET target receptors
  • Pregnancy or breastfeeding
  • Contraindications to MRI such as metal implants or fragments
  • History of alcoholism or substance abuse within 3 years
  • Positive drug screen for substances of abuse
  • History of cancer
  • Claustrophobia
  • Severe back pain preventing prolonged scanning
  • Contraindication for arterial cannulation (Cohort 2 only)
  • Inability to communicate or cooperate with study team
  • Participation in clinical trials with therapies targeting PET receptors within 3 months
  • Any condition interfering with safety or tolerability assessments

AI-Screening

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Trial Site Locations

Total: 1 location

1

King's College London

London, England, United Kingdom, SE5 8AF

Actively Recruiting

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Research Team

S

Steve Williams, PhD

CONTACT

D

Daniel J van Wamelen, PhD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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