An observational study in Huntington Disease, sponsored by King's College London. Recruiting at 1 site in United Kingdom. Open to participants aged 21 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-03-05.
Sponsored by King's College London · Observational
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Among 51 studies in Huntington Disease with a site in United Kingdom — 10 open to participants now, 15 under way, 3 of them phase 3. Huntington Disease · United Kingdom.
Among the 51 studies in Huntington Disease with a site in United Kingdom, this one is the 8th largest by planned enrollment of the 13 observational ones that give a count, is one of 3 that started in 2021, is one of 13 observational ones, reaches primary completion later than 5 of the 14 other live ones, and was the 23rd registered.
293 studies on the registry are indexed under Huntington Disease; 54 are open to participants now.
Browse Huntington Disease studies →10 of the 51 studies in Huntington Disease with a site in United Kingdom are open now. Recruiting first, the newest first:
Prilenia · Sites in United Kingdom, United States, Belgium and 9 more countries
Ages 23–65
Sarepta Therapeutics, Inc. · Sites in United Kingdom, Australia, New Zealand and 1 more country
Ages 21–70
Novartis Pharmaceuticals · Sites in United Kingdom, United States, Argentina and 24 more countries
Ages 21–70
Skyhawk Therapeutics, Inc. · Sites in United Kingdom, United States, Argentina and 7 more countries
Ages 25+
Alnylam Pharmaceuticals · Sites in United Kingdom, Canada, Germany
Ages 25–70
A study can be open while its sites in United Kingdom have not opened yet or have stopped. Only those recruiting at a site in United Kingdom →
Of the 43 Huntington Disease studies recruiting now, 19 (44%) set no upper age limit and 20 (47%) stop at 75 or younger; 5 take children under 18; 20 take healthy volunteers.
This study: 21 Years to 75 Years · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
51 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 14 · Phase 2 22 · Phase 3 8
First in 2004; this study’s year is marked. 3 started in 2021.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 113 is above the median of 90 across 82 observational studies indexed under Huntington Disease.
Median enrollment 92 across the 38 interventional studies, 154 across the 13 observational. Of the 32 that completed or were terminated, 21 (66%) have results posted.
This tab as a report to print or save as PDF → With an account.
36 of 51 have an industry lead sponsor. The 10 most frequent:
King's College London is the lead sponsor of 521 studies on the registry; 127 are open to participants now.
King's College London has 1 study filed under Huntington Disease — fewer than ten, so there is no comparison to draw.
4 of the studies in Huntington Disease with a site in United Kingdom that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07246941Hoffmann-La RocheA Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RG6496 in Huntington's Disease | 2026-12-01 |
| NCT02855476University College, LondonHDClarity: a Multi-site Cerebrospinal Fluid Collection Initiative to Facilitate Therapeutic Development for Huntington's Disease | 2027-04-30 |
| NCT03434548King's College LondonIMarkHD: in Vivo Longitudinal Imaging of HD Pathology | 2027-06-30 |
| NCT07536061Sarepta Therapeutics, Inc.A First-in-human Study of the Effects of SRP-1005 in Participants With Huntington's Disease | 2027-11-30 |
Add all 4 to your calendar (.ics) → With an account.
Among the 51 studies in Huntington Disease with a site in United Kingdom, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
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).
It is likely that, over time, multiple pathophysiological changes influence Huntington's disease (HD) progression. Rather than focusing on one element, the combined PET and multi-modal MRI assessments in this study will allow comprehensive examination of the molecular, functional, and structural framework of HD progression in the brain. The investigators will compare PET and MRI measurements at different disease stages with age- and sex-matched healthy control (HC) participants and monitor, over follow-up visits, to evaluate how specific or combinatorial changes may influence the development of symptoms and disease progression. Furthermore, disease progression markers may be identified that can characterize and predict events preceding symptom development, which could be used as outcome measures in future clinical trials. Study results could also lead to the development of new targeted therapies.
The study has two main objectives. First, to use a series of PET scans to investigate four target receptors in specific areas of the brain that are affected by HD and are thought to be responsible for the motor, cognitive, and behavioral symptoms. Second, to investigate structural and functional changes, including alterations in brain connections, using a multi-modal MRI protocol. The investigators will combine MRI and PET findings with clinical measures to precisely characterize univariate and multivariate markers of disease progression.
There will be two (2) cohorts in this study. Cohort 1 will consist of five (5) HC participants (who do not have the HD gene mutation) recruited and enrolled to enable optimization of MRI imaging techniques. Each participant in Cohort 1 will complete a minimum of 3 visits. Cohort 2 will consist of 72 people with HD (PwHD) and 36 HC participants; each participant will complete a minimum of 10 visits over three (3) years. The 72 PwHDs will be recruited into three (3) groups depending on disease stage: 24 PwHDs who do not have symptoms and are predicted to develop clinically relevant symptoms in a few years; 24 PwHDs with symptoms in early disease stages; and 24 PwHDs with symptoms in advanced disease stages.
The investigators will conduct a preliminary analysis after all baseline visits are completed and a decision will be made whether to add an additional group of 24 PwHDs with no symptoms and who are several years away from developing symptoms, and an additional 12 HCs. After 50% of participants have completed Year 2 follow-up visits, preliminary analysis will be carried out to determine whether to extend the study to include a Year 3 follow-up visit which would be identical to the Year 1 and 2 follow-up visits.
People with Huntington's disease (PwHD) and healthy controls (HCs). PwHD participants will be recruited from specialty clinics known as Participant Identification Centers (Human Genetics, Neurology, Psychiatry) that advise and treat people affected by HD. Participants may receive information about the study through a website, clinical practices, advocacy newsletters, or other approved sources. Community controls will be recruited using advertisements, flyers, and newsletters with the support of the iMarkHD operational staff.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
PwHDs and HC participants:
PwHDs without symptoms: (approximately HD-ISS stage 0 or 1)
If one of the following criteria is met:
If one of the following criteria is met:
Healthy Controls (HC):
Exclusion Criteria:
PwHD and HC participants:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Healthy controls. Multi-modal MRI imaging.
Other: Multi-modal MRI imaging
People with Huntington's (without symptoms, early disease stage, and later disease stage), and healthy controls People with HD divided in groups according to disease stage: * Without symptoms (approximately HD-ISS stage 0 or 1) * Early disease (approximately HD-ISS stage 2) * Later disease stage (approximately HD-ISS stage 3)
Radiation: PET imaging · Other: Multi-modal MRI imaging
PET imaging Radiation: Radioligand \[¹¹C\]MePPEP Intravenous injection of radioligand in the arm with PET imaging of the brain. Radiation: Radioligand \[¹¹C\]IMA107 Intravenous injection of radioligand in the arm with PET imaging of the brain. Radiation: Radioligand \[¹¹C\]MDL100907 Intravenous injection of radioligand in the arm with PET imaging of the brain. Radiation: Radioligand \[¹¹C\]MDL100907 Intravenous injection of radioligand in the arm with PET imaging of the brain. PET imaging Radiation: Radioligand \[¹¹C\]MePPEP Intravenous injection of radioligand in the arm with PET imaging of the brain. Radiation: Radioligand \[¹¹C\]IMA107 Intravenous injection of radioligand in the arm with PET imaging of the brain. Radiation: Radioligand \[¹¹C\]MDL100907 Intravenous injection of radioligand in the arm with PET imaging of the brain. Radiation: Radioligand \[¹¹C\]MDL100907 Intravenous injection of radioligand in the arm with PET imaging of the brain.
Multi-modal MRI imaging
Primary outcome measure 1
Quantitative change in binding profile of four discrete molecular PET markers over the period of 2 years. These markers include: 1. Cannabinoid 1 Receptor binding. 2. Phosphodiesterase 10A enzyme binding. 3. 5-hydroxytryptamine-2A receptor binding. 4. Histamine type-3 receptor binding. The study will assess basal ganglia and cortical pathology with four highly specific PET radioligands (\[11C\]MePPEP, \[11C\]IMA107, \[11C\]MDL100907 and \[11C\]MK-8278), tagging 4 targets of interest: cannabinoid type 1 receptors (CB1R), phosphodiesterase 10A (PDE-10A), 5-hydroxytryptamine-2A receptor (5-HT2AR) and histamine type-3 receptors (H3R), respectively, at baseline, 1 and 2years. The main focus will be on the basal ganglia.
Time frame: 2 years
Primary outcome measure 2
Determine whether selected PET markers could be used as markers of HD disease progression and treatment response in therapeutic trials. These markers include: 1. Cannabinoid 1 Receptor binding. 2. Phosphodiesterase 10A enzyme binding. 3. 5-hydroxytryptamine-2A receptor binding. 4. Histamine type-3 receptor binding. The study will assess basal ganglia and cortical pathology with four highly specific PET radioligands (\[11C\]MePPEP, \[11C\]IMA107, \[11C\]MDL100907 and \[11C\]MK-8278), tagging 4 targets of interest: cannabinoid type 1 receptors (CB1R), phosphodiesterase 10A (PDE-10A), 5-hydroxytryptamine-2A receptor (5-HT2AR) and histamine type-3 receptors (H3R), respectively, at baseline, 1 and 2years. These outcomes will be linked to scale-based and other clinical outcomes performed over the same timelines to determine the link between clinically defined disease progression and the PET markers.
Time frame: 2 years
Plan to share: Undecided
No publications or documents are linked to this record.
Started Jul 2021 (actual). Primary completion is estimated for Jun 2027, 71 months after the start.
Of 34 observational studies under Huntington Disease, half reached primary completion within 47 months of starting (the median), counting those still running; a quarter within 34. This study's planned 71 months is above that.
How these figures are worked out, and which studies are left out of them.
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