Biomarkers in Intermediate Allele Carriers, Adult-, and Early-onset Huntington*s Disease Patients.

Biomarkers in Intermediate Allele Carriers, Adult-, and Early-onset Huntington*s Disease Patients. - Hunting for Biomarkers

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON56656

Enrollment

Registered

2023-08-03

Start date

2024-09-19

Completion date

Unknown

Last updated

2025-12-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Huntington's Disease

Interventions

Not applicable.

Eligibility

Age

16 Years to 99 Years

Inclusion criteria

Inclusion criteria: General inclusion criteria: - Is able to travel to the MaastrichUMC+ or the LUMC for the on-site visits; - Written informed consent must be obtained from the participant and/or legal representative. Inclusion criteria for Intermediate Allele carriers: • Determined CAG repeat length of 27 - 35; • Age of 40 years or older. Inclusion criteria for adult-onset HD patients: • Determined CAG repeat length of 40 - 45; • HD onset >= 40 years of age; • Age of 40 years or older. Inclusion criteria for early-onset HD patients: • Determined CAG repeat length of >= 40; • HD onset

Exclusion criteria

Exclusion criteria: - Use of investigational drugs or participation in a clinical drug trial,  during the study period and/or within 6 months prior to the first study visit; - Prior use of Tominersen (antisense oligonucleotide investigational drug); - Current intoxication, drug, or alcohol abuse or dependence; - Pregnancy; - Severe chorea that, in the investigator's judgment, precludes the patient's  participation in and completion of the MRI and/or lumbar puncture; - General contra-indications to MRI scanning; - For those participants who consider to consent for a lumbar puncture, general  contra-indications for lumbar puncture.

Design outcomes

Primary

Measure	Time frame
The main study parameters are the baseline values and annual measurements of biomarkers in blood, CSF and MR imaging, in combination with the baseline values and annual measurements in clinical outcome measures, in the four groups: IA carriers, AHD patients, EoHD patients, and healthy controls. Comparison of baseline values and change over time of biomarkers and clinical outcome measures of EoHD patients and AHD patients, EoHD patients and healthy controls, and of IA carriers and AHD patients, and IA carriers and healthy controls.	—

Measure

Time frame

The main study parameters are the baseline values and annual measurements of biomarkers in blood, CSF and MR imaging, in combination with the baseline values and annual measurements in clinical outcome measures, in the four groups: IA carriers, AHD patients, EoHD patients, and healthy controls. Comparison of baseline values and change over time of biomarkers and clinical outcome measures of EoHD patients and AHD patients, EoHD patients and healthy controls, and of IA carriers and AHD patients, and IA carriers and healthy controls.

—

Secondary

Measure	Time frame
Phenotype of IA carriers: baseline values and change over time of biomarkers and clinical outcome measures of IA carriers, and the comparison with age-matched controls. Extraction of PBMCs from blood, that will be reprogrammed into iPSCs, to generate patient-derived disease models, from IA carriers, AHD patients, and EoHD patients.	—

Countries

Netherlands

Contacts

Public ContactM. Oosterloo

Universiteit Maastricht

expertisecentrumhuntington@mumc.nl+31(0)43-3877676

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)