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Showing 1-20 of 38 trials
NCT07537075
The goal of this clinical trial is to test if the drug SKY-0515, an oral medication, can lower harmful proteins linked to Huntington's Disease (HD) and improve the symptoms of participants with HD. This study includes men and women aged 25 and older who have HD confirmed by genetic testing and meet certain requirements for physical ability and independence.
NCT07503743
Huntington's disease (HD) is a genetic, progressive neurodegenerative disorder characterized by early and widespread brain changes that can begin more than a decade before the onset of unequivocal motor signs. Although biological indicators of neurodegeneration-including striatal and cortical atrophy, white-matter disruption, and elevated plasma and CSF biomarkers-are detectable during the premanifest stage, cognitive performance typically appears within normal limits when assessed with conventional neuropsychological instruments. In symptomatic HD, cognitive impairment is highly heterogeneous among individuals with similar CAG repeat length, suggesting that mechanisms beyond the primary HTT mutation contribute to variable clinical expression. The objective of this study is to develop and validate novel cognitive assessment instruments that are sensitive to early disease-related changes and capable of characterizing distinct cognitive phenotypes across the HD spectrum. Specifically, the investigators aim to: 1. identify cognitive measures related to brain alterations occurring in premanifest and early-manifest HD; 2. develop approaches for precise cognitive stratification of symptomatic patients; 3. generate predictive models of cognitive trajectories; and 4. explore additional pathophysiological mechanisms-particularly tau-related pathology-that may modulate neurodegeneration and cognitive heterogeneity. To address these objectives, the study integrates multimodal biomarkers, including PET imaging with the tau tracer 18F-PI-2620, structural MRI, plasma biomarkers (neurofilament light chain and tau), and detailed cognitive testing. PET with 18F-PI-2620 will be used to quantify regional tau burden and to examine associations with cognitive performance, neurodegenerative patterns, and clinical phenotypes in HD. This tracer has demonstrated an adequate safety profile in prior human studies and is currently used at the study institution in other research protocols. This pilot, open-label, single-center Phase IIa study will recruit 90 participants: 30 healthy controls, 30 premanifest HD gene carriers, and 30 early-to-intermediate stage symptomatic patients. All participants will undergo a single administration of 185 MBq of 18F-PI-2620 followed by a 90-minute dynamic PET acquisition. Imaging data will be co-registered with MRI and analyzed using standardized uptake value ratios (SUVR) with the cerebellum as reference region. Cognitive assessments and blood sampling will be completed within 15 days of PET imaging. Primary outcome measures include regional SUVR values obtained from 18F-PI-2620 PET and their association with early neurodegenerative changes. Secondary outcomes include correlations between PET measures, cognitive performance, MRI-derived cortical and subcortical atrophy, and plasma biomarkers. Safety will be assessed through direct observation for two hours following tracer administration and through a structured follow-up telephone call at 24 hours. The overarching goal of the study is to establish biologically guided cognitive instruments capable of detecting subtle premanifest changes, capturing the heterogeneous cognitive expression of HD, and supporting future therapeutic trials, particularly in individuals at the earliest disease stages.
NCT02855476
HDClarity will seek at least 2500 research participants at different stages of Huntington's disease (HD). The primary objective is to collect a high quality CSF sample for evaluation of biomarkers and pathways that will enable the development of novel treatments for HD. The secondary objective is to generate a high quality plasma sample collection matching the CSF collections, which will also be used to evaluate biomarkers and pathways of relevance to HD research and development.
NCT04120493
This is the first study of AMT-130 in patients with early manifest HD and is designed to establish safety and proof-of-concept (PoC). CT-AMT-130-01 is a Phase 1/2, multicenter, first-in-human (FIH) study. The first three cohorts of the study have completed enrollment, including the randomized, double-blind, sham-controlled cohorts. Cohort 4 is open-label. Cohort 4 participants will receive high dose AMT-130.
NCT05107128
The primary purpose of this study is to evaluate the effect of SAGE-718 on cognitive performance and functioning in participants with HD.
NCT03664804
The study is designed as a multi-site, prospective, 15-month longitudinal, cohort study measuring CSF mHTT in participants with early manifest Stage I or Stage II Huntington's Disease (HD).
NCT01574053
Enroll-HD is a longitudinal, observational, multinational study that integrates two former Huntington's disease (HD) registries-REGISTRY in Europe, and COHORT in North America and Australasia-while also expanding to include sites in Latin America. More than 30,000 participants have now enrolled into the study. With annual assessments and no end date, Enroll-HD has built a large and rich database of longitudinal clinical data and biospecimens that form the basis for studies developing tools and biomarkers for progression and prognosis, identifying clinically-relevant phenotypic characteristics, and establishing clearly defined endpoints for interventional studies. Periodic cuts of the database are now available to any interested researcher to use in their research - visit www.enroll-hd.org/for-researchers/access-data/ to learn more.
NCT01592552
The purpose of this research project is to collect and store blood samples and clinical data. Researchers can then use the stored samples in future studies. Through such studies, they hope to find new ways to detect, treat, and maybe even prevent or cure health problems.
NCT00670709
The pace of basic science research defining the mechanisms of selective neuronal degeneration in Huntington disease (HD) has far exceeded the pace of translation of this information into clinically effective treatments for the disease. One reason for this bottleneck between bench and bedside is the paucity of available surrogate markers for HD. Identification of surrogate markers is critical for the design of future clinical trials. Such markers could provide a reliable signal of early brain dysfunction in HD and could be used as a biomarker in trials of agents that could prevent onset or delay progression of disease. Frontal-subcortical networks are known to be affected in HD and contribute to the cognitive dysfunction characteristic of the disease. Quantitative EEG (QEEG) can be used to assess the integrity of this circuitry; characteristic QEEG abnormalities long have been known to be present in the early stages of the illness (Bylsma et al., 1994). More recent research has suggested that a comprehensive topographic approach to QEEG analysis may reveal additional changes in brain activity (Bellotti et al., 2004) that may be indicative of subclinical disease (de Tommaso et al., 2003). This proposal aims to determine whether quantitative EEG techniques can be used to identify HD-specific abnormalities and thus serve as surrogate markers of disease. The goals of this pilot project are three-fold. First, we will determine if there are QEEG differences between normal control subjects and those with mild or moderate HD. Second, we will examine associations between severity of HD and the QEEG differences detected and determine if these QEEG differences are present when comparing the least affected HD subjects and normal controls. Third, we will examine associations between QEEG variables of interest and other clinical variables, including age of onset of symptoms, number of CAG repeats, severity of motor and behavioral symptoms as measured by the Unified Huntington Disease Rating Scale (UHDRS) subscores, and severity of cognitive impairment as measured by the cognitive subscore of the UHDRS and Mini-Mental State Examination (MMSE).
NCT00665223
The purpose of this study is to determine if ACR16 is effective and safe in the symptomatic treatment of Huntington's disease.
NCT03225846
PRECISION-HD2 is a Phase 1b/2a multicenter, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of single and multiple doses of WVE-120102 in adult patients with early manifest Huntington's disease (HD) who carry a targeted single nucleotide polymorphism (SNP) rs362331 (SNP2).
NCT03342053
This study will test the safety, tolerability, pharmacokinetics and pharmacodynamics of RO7234292 administered intrathecally to adult patients with Huntington's Disease.
NCT03225833
PRECISION-HD1 is a Phase 1b/2a multicenter, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of single and multiple doses of WVE-120101 in adult patients with early manifest Huntington's disease (HD) who carry a targeted single nucleotide polymorphism (SNP) rs362307 (SNP1).
NCT02006472
This is a multicenter, multinational, randomized, parallel-group, double-blind, placebo-controlled, dose range finding study to compare the efficacy and safety of different doses of pridopidine versus placebo in the treatment of motor impairment in Huntington's Disease (HD).
NCT02215616
The primary objective of this study is to assess the efficacy of laquinimod as treatment in participants with HD after 52 weeks using the Unified Huntington's Disease Rating Scale Total Motor Score (UHDRS-TMS or TMS).
NCT02216474
Brain stimulation in movement disorders This trial will explore the effects of very gentle electrical stimulation of the brain in patients with movement disorders. Other studies have already been carried out and have shown that brain stimulation may help to improve mental abilities and the symptoms of conditions such as depression and stroke. The investigators will show whether this method can help with symptoms such as memory and concentration problems in patients with movement disorder who have mild to moderate problems with these mental abilities. The investigators will also look at the effects of brain stimulation on movement symptoms and mood. These people will be compared to healthy people to help us understand whether brain stimulation works differently in healthy people and people with brain disorders. This trial is being carried out at one centre in Birmingham. It is scheduled to begin in September 2014 and will last for up to five years. As the study commences it is being funded by Birmingham and Solihull Mental Health Foundation Trust and University of Birmingham. The investigators plan to recruit up to a maximum of 200 individuals in this study.
NCT03306888
This study will evaluate the feasibility and acceptability of a clinic-based physical activity coaching intervention in people with pre-manifest and early stage Huntington's Disease (HD). Fourteen individuals with premanifest and early stage HD will be recruited to participate in a 4 month coaching intervention. Feasibility will be assessed by recruitment and retention rates, and acceptability will be assessed by participant interviews. Participants will also be evaluate at baseline and following the coaching intervention to explore preliminary efficacy in terms of physical activity, self efficacy, disease-specific motor and cognitive function, walking endurance and strength.
NCT02074410
The purpose of this study is to determine the safety, tolerability and pharmacokinetics of OMS643762 (the study drug) in subjects with Huntington's disease (HD).
NCT00827034
This study will evaluate the potential drug-drug interaction of Dimebon with the FDA-recommended CYP2C9 substrate warfarin in healthy subjects. Conformance with the guidance includes general study design using a randomized, open label, single-dose warfarin, steady-state Dimebon, 2-sequence, 2-treatment, 2-period crossover design with a minimum 7-day washout period between treatments.
NCT02750982
This is a prospective investigation of the effects of Laughter therapy (LT) on perceived stress, self-efficacy, mood and other wellness measures in people with the following neurological conditions: Alzheimer's disease, amyotrophic lateral sclerosis, brain injury, Huntington's Disease, multiple sclerosis, Parkinson's Disease, post-stroke, spinal cord injury.