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Innovative Imaging and Cognitive BIOmarkers to Predict Huntington's Disease Progression
EU CTIS ID: 2024-516022-63-00
What this study is testing
Identify biomarkers, used singly or in combination, that enable sensitive measurement of the progression of Huntington's disease from the presymptomatic stages onwards, within the framework of clinical trials.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- For all participants: - Age ≥18 years and ≤65 years; - Information and collection of written consent; - Affiliation with a social security plan, beneficiary or beneficiary's right
- For Healthy volunteers (control): - UHDRS functional score TFC = 13; - Motor UHDRS score TMS < 6; - With no known genetic disease and no direct relationship to an HD patient or family ancestors carrying the HD mutation (or knowing their genetic status with CAG < 36)
- For Symptomatic huntington's disease patients: - Number of GACs ≥ 40; - CAP score ≥ 250; - 10 ≤ TFC ≤ 13; - TMS >5 if TFC=13; - Diagnostic confidence level =4; - Age of onset of disease > 20 years ; - Patient physically able to sign consent
- For Pre-symptomatic Huntington's disease patients: - Number of GACs ≥ 40; - CAP score ≥250; - TFC = 13; - TMS < 6; - Patient physically able to sign consent
You likely can't join if
- Participant under guardianship or curatorship
- Pregnant or breastfeeding woman
- Person under state medical aid
- Person deprived of liberty
- Person participating or having participated in an interventional study for less than 3 months or without time limit in a trial of neural transplants or gene therapy.
- Person participating or having participated in a research protocol with a radiopharmaceutical injection for less than 12 months.
See the full eligibility criteria
- For all participants: - Age ≥18 years and ≤65 years; - Information and collection of written consent; - Affiliation with a social security plan, beneficiary or beneficiary's right
- For Healthy volunteers (control): - UHDRS functional score TFC = 13; - Motor UHDRS score TMS < 6; - With no known genetic disease and no direct relationship to an HD patient or family ancestors carrying the HD mutation (or knowing their genetic status with CAG < 36)
- For Symptomatic huntington's disease patients: - Number of GACs ≥ 40; - CAP score ≥ 250; - 10 ≤ TFC ≤ 13; - TMS >5 if TFC=13; - Diagnostic confidence level =4; - Age of onset of disease > 20 years ; - Patient physically able to sign consent
- For Pre-symptomatic Huntington's disease patients: - Number of GACs ≥ 40; - CAP score ≥250; - TFC = 13; - TMS < 6; - Patient physically able to sign consent
- Participant under guardianship or curatorship
- Pregnant or breastfeeding woman
- Person under state medical aid
- Person deprived of liberty
- Person participating or having participated in an interventional study for less than 3 months or without time limit in a trial of neural transplants or gene therapy.
- Person participating or having participated in a research protocol with a radiopharmaceutical injection for less than 12 months.
- Neurological or psychiatric disorder unrelated to HD
- Intercurrent illness that may impact participant's performance
- Chronic progressive neurological disease
- Claustrophobia
- Brain injury unrelated to HD
- Pacemaker, intracorporeal metal, intracerebral clip, any metallic foreign body: implantable cardiac electronic device such as pacemakers, implantable cardioverter defibrillators etc., metallic intraocular foreign bodies, implantable neurostimulation systems, cochlear implants/ear implants, drug infusion pumps (insulin administration, analgesic drugs), or chemotherapy pumps): if possible, the patient should remove the device.
- Catheters with metal components (Swan-Ganz catheter), metal fragments such as bullets, shotgun pellets and metal shrapnel, cerebral artery aneurysm clips, magnetic dental implants, tissue expander, artificial limb, hearing aid, piercing such as pacemaker
- Known hypersensitivity to the radiopharmaceutical preparation (excipients in the radiopharmaceutical preparation)
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.