Huntington DiseaseNCT03434548
IMarkHD: in Vivo Longitudinal Imaging of HD Pathology
An observational study of Huntington Disease, run by King's College London at 1 site in United Kingdom.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 21 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Huntington Disease
- What is being tested?
- PET imaging and Multi-modal MRI imaging
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 113 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 20 Jul 2021to 30 Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 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.
Who may be able to join
- PwHDs and HC participants:
- Female and male adults, aged 21-75 years old, inclusive.
- Adequate visual (Snellen chart) and auditory (Rinne and Weber tests) acuity to complete the psychological testing as determined by the investigator.
- Capable of giving informed consent.
- Willing to comply with highly effective contraceptive measures following informed consent (for Cohort 2 only).
- Vital signs within certain set ranges.
Show all 27Show fewer
- Considered by the investigator to be in good health as judged by the absence of clinically significant diseases, laboratory values, physical examination, and able to travel to imaging and clinical assessment centers in London, UK.
- Suitable physically and psychologically to travel (with a companion if requested) and undergo the assessments as judged by the investigator.
- PwHDs without symptoms: (approximately HD-ISS stage 0 or 1)
- HDGECs with ≥ 40 CAG repeats
- TMS ≤ 6 AND TFC ≥ 12 AND CAP > 70 PwHDs with symptoms in early disease: (approximately HD-ISS stage 2)
- HDGECs with ≥ 40 CAG repeats
- If one of the following criteria is met:
- TMS ≤ 6 AND TFC = 11
- TMS is between 7 and 23 inclusive AND TFC is between 11 and 13 inclusive
- TMS is between 24 and 33 inclusive AND SDMT > 50 AND TFC is between 11 and 13 inclusive PwHDs with symptoms in late disease (approximately HD-ISS stage 3)
- HDGECs with ≥ 40 CAG repeats
- If one of the following criteria is met:
- TMS ≤ 6 AND TFC is between 7 and 10 inclusive
- TMS is between 7 and 23 inclusive AND TFC is between 8 and 10 inclusive
- TMS is between 24 and 33 inclusive AND SDMT > 50 AND TFC is between 7 and 10 inclusive
- TMS is between 7 and 23 inclusive AND TFC = 7
- TMS > 23 AND SDMT ≤ 50 AND TFC is between 7 and 13 inclusive
- TMS > 33 AND SDMT > 50 AND TFC is between 7 and 13 inclusive
- Healthy Controls (HC):
- Age- and sex-matched, and balanced (±8 years) with PwHDs.
- No known family history of HD or have known family history of HD but have been tested for the huntingtin gene glutamine codon (CAG) expansion and are not at genetic risk for HD (CAG < 36).
Who cannot join
- PwHD and HC participants:
- Presence or history of other neurological condition (including brain surgery, intracranial hematoma, stroke/cerebrovascular disorders, demyelinating conditions, epilepsy) likely to interfere with imaging or PET studies or abnormal neurologic examination finding suggestive of a central nervous system pathology (for PwHDs - other than HD).
- Presence or history of primary psychiatric disorders unrelated to HD.
- Participants using any medications with known actions on cannabinoid type 1 receptors (CB1R), phosphodiesterase 10A (PDE-10A), 5-hydroxytryptamine-2A receptor (5-HT2AR), histamine type-3 receptors (H3R), or any other PET targets used in iMarkHD.
- Pregnancy confirmed by a positive urine pregnancy test.
- Participants who are currently breastfeeding or intend to breastfeed during the study.
Show all 16Show fewer
- Contraindication to MRI, such as presence of metal devices or implants (e.g. pacemaker, vascular- or heart- valves, stents, clips), metal deposited in the body (e.g. bullets or shells), or metal grains in the eyes.
- History of alcoholism or substance abuse within 3 years prior to study entry.
- Failure of drug screen for substances of abuse such as amphetamines, barbiturates, benzodiazepines, methadone, opiates, cocaine, cannabinoids, phencyclidine, and creatine.
- History of cancer.
- Claustrophobia.
- Significant back pain that makes prolonged laying on the PET or MRI scanner intolerable.
- Contraindication for arterial cannulation as judged by the Allen test and the laboratory blood screening for coagulopathy (Cohort 2 only).
- Inability to communicate or cooperate with the principal investigator/iMarkHD team 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 3 months of screening.
- Any concurrent conditions that could interfere with the safety and/or tolerability measurements.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
King's College London
London, England, SE5 8AF
Daniel J van Wamelen, PhD, 0044-(0)-203-228-3084, daniel.van_wamelen@kcl.ac.uk
About this study
Official title: Longitudinal Adaptive Study of Molecular Pathology and Neuronal Networks in Huntington's Disease Gene-Expansion Carriers (HDGEC) and Healthy Controls Using Positron Emission Tomography (PET) and Multi-modal Magnetic Resonance Imaging (MRI)
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).
Read the detailed description
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.
- Conditions
- Huntington Disease
- Being tested
- PET imaging, Multi-modal MRI imaging
- Keywords
- Huntington's disease, PET imaging, MRI imaging
- Medical subject headings
- Huntington Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PET imagingRadiation
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 imagingOther
Multi-modal MRI imaging
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Healthy controls. Multi-modal MRI imaging. Receives: Other: Multi-modal MRI imaging | |
| Cohort 2 | 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) Receives: Radiation: PET imaging; Other: Multi-modal MRI imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary outcome measure 1
Quantitative change in binding profile of four discrete molecular PET markers over the period of 2 years.
These markers include:
- Cannabinoid 1 Receptor binding.
- Phosphodiesterase 10A enzyme binding.
- 5-hydroxytryptamine-2A receptor binding.
- 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.
Measured: 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:
- Cannabinoid 1 Receptor binding.
- Phosphodiesterase 10A enzyme binding.
- 5-hydroxytryptamine-2A receptor binding.
- 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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2018
- Study start20 Jul 2021
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Huntington DiseaseStudies of the same condition, open and under way.
- More trials run by King's College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 113 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Collaborators
- CHDI Foundation, Inc.
- Responsible party
- Sponsor
- Investigators
- Steve Williams, PhD, Study chair, King's College LondonDaniel J van Wamelen, PhD, Principal investigator, King's College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03434548
- Sponsor's protocol ID
- IRAS 242859
- Status last verified
- Mar 2025
- First submitted
- 7 Feb 2018
- Last updated
- 5 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Adaptive Study of Molecular Pathology and Neuronal Networks in Huntington's Disease Gene-Expansion Carriers (HDGEC) and Healthy Controls Using Positron Emission Tomography (PET) and Multi-modal Magnetic Resonance Imaging (MRI)
- ClinicalTrials.gov ID
- NCT03434548
- Acronym / sponsor ID
- IRAS 242859
- Conditions
- Huntington Disease
- Keywords
- Huntington's disease, PET imaging, MRI imaging
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 113 participants (estimated)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Collaborators
- CHDI Foundation, Inc.
- Study start
- 20 Jul 2021 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 15 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | – | Other: Multi-modal MRI imagingHealthy controls. Multi-modal MRI imaging. |
| Cohort 2 | – | Radiation: PET imaging, Other: Multi-modal MRI imagingPeople 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) |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (27 listed)
- Female and male adults, aged 21-75 years old, inclusive.
- Adequate visual (Snellen chart) and auditory (Rinne and Weber tests) acuity to complete the psychological testing as determined by the investigator.
- Capable of giving informed consent.
- Willing to comply with highly effective contraceptive measures following informed consent (for Cohort 2 only).
- Vital signs within certain set ranges.
Key exclusion criteria (16 listed)
- Presence or history of other neurological condition (including brain surgery, intracranial hematoma, stroke/cerebrovascular disorders, demyelinating conditions, epilepsy) likely to interfere with imaging or PET studies or abnormal neurologic examination finding suggestive of a central nervous system pathology (for PwHDs - other than HD).
- Presence or history of primary psychiatric disorders unrelated to HD.
- Participants using any medications with known actions on cannabinoid type 1 receptors (CB1R), phosphodiesterase 10A (PDE-10A), 5-hydroxytryptamine-2A receptor (5-HT2AR), histamine type-3 receptors (H3R), or any other PET targets used in iMarkHD.
- Pregnancy confirmed by a positive urine pregnancy test.
- Participants who are currently breastfeeding or intend to breastfeed during the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PET imagingPET 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. | Radiation | Cohort 2 |
| Multi-modal MRI imagingMulti-modal MRI imaging | Other | Cohort 1, Cohort 2 |
Primary outcome
Primary outcome measure 1
Time frame: 2 years
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.
Primary outcome measure 2
Time frame: 2 years
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Huntington Disease
RecruitingPhase 2/3
Study to Evaluate the Pharmacodynamics, Safety and Efficacy of SKY-0515 in Participants With Huntington's Disease
Huntington Disease
RecruitingPhase 3
Pridopidine Phase 3 Study in Huntington's Disease
Huntington Disease
Not yet recruiting
Creatine and Beta-Hydroxy-Beta-Methylbutyrate (HMB) Supplementation Plus Home-Based Exercise for Sarcopenia in Huntington's Disease
Huntington Disease, Sarcopenia
Recruiting
Feasibility and Acceptability of an LLM-based Chatbot for Family Caregivers: Evaluation Study
Caregivers
RecruitingObservational study
Development of Non-Invasive Prenatal Diagnosis for Single Gene Disorders
Invasive PreNatal Diagnosis in a Context of Family History of Single-gene Disorders, Including, Sickle Cell Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Steve Williams, PhD study chair
King's College London
Daniel J van Wamelen, PhD principal investigator
King's College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Huntington Disease, run by King's College London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 27 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Steve Williams, PhD (0044-(0)-203-228-3063, steve.williams@kcl.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary outcome measure 1 (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2025.