Huntington Disease Clinical Trial
Official title:
Direct Quantitative Comparison Between [11C]UCB-J and [18F]SynVest-1 PET as Markers for Synaptic Density in Premanifest and Manifest Huntington's Disease.
Positron Emission Tomography (PET) is a functional imaging technique, which enables in vivo visualization of biological molecules expressed in human tissues. Brain PET is most powerful to study a vast range of neurological and psychiatric disorders in vivo, targeting neuronal and glial activity, metabolism, cerebral blood flow, receptor proteins or misfolded proteins. In vivo imaging of synaptic density in the human brain has become feasible through development of [11C]UCB-J, a PET radioligand for the synaptic vesicle protein SV2A, which is ubiquitously and homogeneously present in presynaptic terminals throughout the brain. A first study in Huntington's disease (HD) mutation carriers showed loss of striatal [11C]UCB-J binding (also when corrected for atrophy), as well as in the neocortex (Delva et al, Neurology 2022). Moreover, regional synaptic loss was highly correlated to motor impairment. In order to be able to use SV2A PET as widespread available biomarker tool to assess synaptic integrity, disease progression and/or response to mHTT lowering drugs, the short half-life of 11C (20 minutes) for [11C]UCB-J remains a hurdle. Recently, [18F]SynVesT-1, an optimized 18F-labeled analogue of [11C]UCB-J with similar kinetics, binding affinity, and test-retest precision properties has been evaluated in humans. However, there is evidence from preclinical studies conducted at University of Antwerp that in the zQ175DN knock-in mouse model of HD, larger variability and lower effect-sizes are seen with [18F]SynVest-1 than with [11C]UCB-J. In order to ascertain a similar effect size and quantification properties for [18F]SynVest-1 and [11C]UCB-J PET in human HD, both in the premanifest and manifest phase, and to validate simplified measures (such as SUVR with white matter as reference region) and SynVest, this head-to-head fully quantitative study is performed.
n/a
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Terminated |
NCT03052712 -
Validation and Standardization of a Battery Evaluation of the Socio-emotional Functions in Various Neurological Pathologies
|
N/A | |
| Not yet recruiting |
NCT04429230 -
Non-invasive Brain Stimulation in Huntington's Disease
|
N/A | |
| Recruiting |
NCT05032196 -
Study of WVE-003 in Patients With Huntington's Disease
|
Phase 1/Phase 2 | |
| Recruiting |
NCT03599076 -
Wearable Sensors for Quantitative Assessment of Motor Impairment in Huntington's Disease Huntington's Disease
|
||
| Terminated |
NCT04617860 -
Open-label Extension Study to Evaluate the Safety and Tolerability of WVE-120102 in Patients With Huntington's Disease
|
Phase 1/Phase 2 | |
| Completed |
NCT05748288 -
Development of the Virtual Unified Huntington's Disease Rating Scale
|
||
| Not yet recruiting |
NCT04370470 -
Development of Assessments for Later Stage HD
|
||
| Recruiting |
NCT01834053 -
Safety and Efficacy of Bone Marrow Derived MNCs for Treatment of Cells for the Treatment of Hunting Tons Chorea.
|
Phase 1/Phase 2 | |
| Completed |
NCT01357681 -
Effects of EGCG (Epigallocatechin Gallate) in Huntington's Disease (ETON-Study)
|
Phase 2 | |
| Completed |
NCT01458470 -
A Trial of Memantine as Symptomatic Treatment for Early Huntington Disease
|
Phase 2 | |
| Completed |
NCT00980694 -
Bioavailability of Ubiquinol in Huntington Disease
|
Phase 1 | |
| Completed |
NCT00146211 -
TREND-HD - A Trial of Ethyl-EPA (Miraxion™) in Treating Mild to Moderate Huntington's Disease
|
Phase 3 | |
| Recruiting |
NCT01412125 -
Study of Biomarkers That Predict the Evolution of Huntington's Disease
|
N/A | |
| Completed |
NCT00075140 -
Family Health After Predictive Huntington Disease (HD) Testing
|
Phase 3 | |
| Recruiting |
NCT04818060 -
Preparing for Prevention of Huntington's Disease (PREVENT-HD)
|
||
| Active, not recruiting |
NCT04698551 -
NIPD on cffDNA for Triplet Repeat Diseases
|
||
| Not yet recruiting |
NCT04301726 -
Efficacy of Deutetrabenazine to Control Symptoms of Dysphagia Associated With HD
|
Phase 1 | |
| Completed |
NCT03421327 -
Genetic Risk: Whether, When, and How to Tell Adolescents
|
||
| Recruiting |
NCT03296176 -
Metabolomic Study in Huntington's Disease (METABO-HD)
|
N/A | |
| Recruiting |
NCT05243017 -
Safety and Efficacy of AMT-130 in European Adults With Early Manifest Huntington's Disease
|
Phase 1/Phase 2 |