Huntington DiseaseNCT04701580
Synaptic Density and Progression of Huntington's Disease.
A study testing 11C-UCB-J PET-CT and 18F-FDG PET-MR in people with Huntington Disease, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
AIM: To assess synaptic density and to investigate the potential relationship of regional synaptic loss with motor and non-motor symptoms and with disease progression in the human brain in vivo in patients with HD. DESIGN: The investigators will include 20 HD mutations carriers and 15 healthy controls. Read more about this study
- Who is it for?
- Ages 20 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Huntington Disease
- What is being tested?
- 11C-UCB-J PET-CT and 18F-FDG PET-MR
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteBelgium
- Study dates
- 14 Jan 2020to 5 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 20 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 20-75 years.
- Capacity to understand the informed consent form.
- For HD group: CAG repeat expansion in HTT ≥ 40.
- Premanifest HD mutation carriers:
- No clinical diagnostic motor features of HD, defined as Unified Huntington's Disease Rating Scale (UHDRS) Diagnostic Confidence Score < 4.
- Early manifest HD patients:
- Clinical diagnostic motor features of HD, defined as Unified Huntington's Disease Rating Scale (UHDRS) Diagnostic Confidence Score = 4.
- UHDRS-TFC score 7 or higher (Shoulson-Fahn stage 1 and 2).
Who cannot join
- neuropsychiatric diseases other than HD
- major internal medical diseases
- white matter lesion load on FLAIR Fazekas score 2 or higher or other relevant MRI abnormalities
- history of alcohol abuse or current alcohol abuse (chronic use of more than 15 units per week) or drug abuse
- contraindications for MR
- pregnancy
- previous participation in other research studies involving ionizing radiation with >1 mSv in the previous 12 months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Longitudinal Measurement of Synaptic Density to Monitor Progression of Huntington's Disease.
AIM: To assess synaptic density and to investigate the potential relationship of regional synaptic loss with motor and non-motor symptoms and with disease progression in the human brain in vivo in patients with HD.
DESIGN: The investigators will include 20 HD mutations carriers and 15 healthy controls. All subjects will undergo a clinical examination, with comprehensive assessment of motor and non-motor symptoms, and imaging evaluation consisting of 11C-UCB-J PET-CT and 18F-FDG PET-MR at baseline and after 2 years.
- Conditions
- Huntington Disease
- Being tested
- 11C-UCB-J PET-CT, 18F-FDG PET-MR
- Keywords
- Huntington Disease, PET, 11C-UCB-J, 18F-FDG, SV2A
- Medical subject headings
- Huntington Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
11C-UCB-J PET-CTDiagnostic test
Positron Emission Tomography (PET) of synaptic vesicle protein 2A (SV2A) using the radioligand 11C-UCB-J.
18F-FDG PET-MRDiagnostic test
Positron Emission Tomography (PET) of glucose metabolism using the radioligand 18F-FDG, and brain MRI performed simultaneously.
| Study group | Role | What they receive |
|---|---|---|
| HD patients | Experimental | At baseline and 2-year follow-up Receives: Diagnostic Test: 11C-UCB-J PET-CT; Diagnostic Test: 18F-FDG PET-MR |
| Healthy controls | Active comparator | At baseline and 2-year follow-up Receives: Diagnostic Test: 11C-UCB-J PET-CT; Diagnostic Test: 18F-FDG PET-MR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Baseline differences in synaptic density.
Baseline differences (%) in (regional) synaptic density between patients and controls.
Measured: Data analysis wel be done when all subjects have undergone the baseline evaluation.
Baseline correlations between clinical scores and regional synaptic density.
Correlations between clinical scores and regional synaptic density in the patient group at baseline.
Measured: Data analysis wel be done when all subjects have undergone the baseline evaluation.
Differences in the rate of decline of synaptic density.
Differences (%) in the rate of decline of synaptic density between patients and controls.
Measured: Data analysis wel be done when all subjects have undergone the 2-year follow-up evaluation.
Correlations between progression of the clinical scores and decline of synaptic density.
Correlations between progression of the clinical scores and decline of synaptic density in the patient group, after longitudinal follow up of 2 years.
Measured: Data analysis wel be done when all subjects have undergone the 2-year follow-up evaluation.
Secondary outcomes (4)
Baseline differences in cerebral glucose metabolism.
Baseline differences (%) in (regional) glucose metabolism between patients and controls.
Measured: Data analysis wel be done when all subjects have undergone the baseline evaluation.
Baseline correlations between clinical scores and cerebral glucose metabolism.
Correlations between clinical scores and cerebral glucose metabolism in the patient group at baseline.
Measured: Data analysis wel be done when all subjects have undergone the 2-year follow-up evaluation.
Differences in the rate of decline of cerebral glucose metabolism.
Differences (%) in the rate of decline in cerebral glucose metabolism between patients and controls.
Measured: Data analysis wel be done when all subjects have undergone the 2-year follow-up evaluation.
Correlations between progression of the clinical scores and decline of cerebral glucose metabolism in the patient group, after longitudinal follow up of 2 years.
Correlations between progression of the clinical scores and decline of cerebral glucose metabolism in the patient group, after longitudinal follow up of 2 years.
Measured: Data analysis wel be done when all subjects have undergone the 2-year follow-up evaluation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2021
- Study start14 Jan 2020
- Primary completion5 Oct 2022
- Study completion5 Oct 2022
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 Universitaire Ziekenhuizen KU LeuvenThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- Longitudinal study design (2 years follow up) where results of SV2A PET/CT, FDG PET/MR and clinical rating scales are compared between HD patients and healthy controls.
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wim Vandenberghe, MD, PhD, Principal investigator, UZ Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04701580
- Sponsor's protocol ID
- s61478
- Status last verified
- Nov 2022
- First submitted
- 5 Jan 2021
- Last updated
- 3 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Needs to be decided.
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Measurement of Synaptic Density to Monitor Progression of Huntington's Disease.
- ClinicalTrials.gov ID
- NCT04701580
- Acronym / sponsor ID
- s61478
- Conditions
- Huntington Disease
- Keywords
- Huntington Disease, PET, 11C-UCB-J, 18F-FDG, SV2A
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- 14 Jan 2020 (actual)
- Primary completion
- 5 Oct 2022 (actual)
- Study completion
- 5 Oct 2022 (actual)
- First posted
- 8 Jan 2021 (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.
AIM: To assess synaptic density and to investigate the potential relationship of regional synaptic loss with motor and non-motor symptoms and with disease progression in the human brain in vivo in patients with HD.
DESIGN: The investigators will include 20 HD mutations carriers and 15 healthy controls. All subjects will undergo a clinical examination, with comprehensive assessment of motor and non-motor symptoms, and imaging evaluation consisting of 11C-UCB-J PET-CT and 18F-FDG PET-MR at baseline and after 2 years.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Longitudinal study design (2 years follow up) where results of SV2A PET/CT, FDG PET/MR and clinical rating scales are compared between HD patients and healthy controls.
| Arm | Type | Receives |
|---|---|---|
| HD patients | Experimental | Diagnostic Test: 11C-UCB-J PET-CT, Diagnostic Test: 18F-FDG PET-MRAt baseline and 2-year follow-up |
| Healthy controls | Active comparator | Diagnostic Test: 11C-UCB-J PET-CT, Diagnostic Test: 18F-FDG PET-MRAt baseline and 2-year follow-up |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age 20-75 years.
- Capacity to understand the informed consent form.
- For HD group: CAG repeat expansion in HTT ≥ 40.
- Premanifest HD mutation carriers:
- Early manifest HD patients:
Key exclusion criteria (7 listed)
- neuropsychiatric diseases other than HD
- major internal medical diseases
- white matter lesion load on FLAIR Fazekas score 2 or higher or other relevant MRI abnormalities
- history of alcohol abuse or current alcohol abuse (chronic use of more than 15 units per week) or drug abuse
- contraindications for MR
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 |
|---|---|---|
| 11C-UCB-J PET-CTPositron Emission Tomography (PET) of synaptic vesicle protein 2A (SV2A) using the radioligand 11C-UCB-J. | Diagnostic test | HD patients, Healthy controls |
| 18F-FDG PET-MRPositron Emission Tomography (PET) of glucose metabolism using the radioligand 18F-FDG, and brain MRI performed simultaneously. | Diagnostic test | HD patients, Healthy controls |
Primary outcome
Baseline differences in synaptic density.
Time frame: Data analysis wel be done when all subjects have undergone the baseline evaluation.
Baseline differences (%) in (regional) synaptic density between patients and controls.
Baseline correlations between clinical scores and regional synaptic density.
Time frame: Data analysis wel be done when all subjects have undergone the baseline evaluation.
Correlations between clinical scores and regional synaptic density in the patient group at baseline.
Differences in the rate of decline of synaptic density.
Time frame: Data analysis wel be done when all subjects have undergone the 2-year follow-up evaluation.
Differences (%) in the rate of decline of synaptic density between patients and controls.
Correlations between progression of the clinical scores and decline of synaptic density.
Time frame: Data analysis wel be done when all subjects have undergone the 2-year follow-up evaluation.
Correlations between progression of the clinical scores and decline of synaptic density in the patient group, after longitudinal follow up of 2 years.
4 secondary outcomes
Baseline differences in cerebral glucose metabolism.
Time frame: Data analysis wel be done when all subjects have undergone the baseline evaluation.
Baseline correlations between clinical scores and cerebral glucose metabolism.
Time frame: Data analysis wel be done when all subjects have undergone the 2-year follow-up evaluation.
Differences in the rate of decline of cerebral glucose metabolism.
Time frame: Data analysis wel be done when all subjects have undergone the 2-year follow-up evaluation.
Correlations between progression of the clinical scores and decline of cerebral glucose metabolism in the patient group, after longitudinal follow up of 2 years.
Time frame: Data analysis wel be done when all subjects have undergone the 2-year follow-up evaluation.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2022.
- Individual participant dataSharing planned: Yes. Needs to be decided.
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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. This study is not recruiting at the moment.
Wim Vandenberghe, MD, PhD principal investigator
UZ Leuven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 11C-UCB-J PET-CT and 18F-FDG PET-MR in people with Huntington Disease, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
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 8 inclusion and 7 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: finished, as of the sponsor's last update on 3 Nov 2022. 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 Belgium. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Baseline differences in synaptic density. (time frame: Data analysis wel be done when all subjects have undergone the baseline evaluation.). The study lists 4 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 3 Nov 2022.