NCT05808153 · RECRUITING
Innovative Imaging and Cognitive BIOmarkers to Predict Huntington's Disease Progression
This trial is studying new brain imaging techniques and cognitive tests to better track Huntington's disease progression. It uses a radiotracer injection to get detailed brain scans, alongside other biological and cognitive measures. Researchers want to find more sensitive markers for the disease before and after symptoms appear. This is a Phase NA observational study — it is gathering data to improve future research tools, not testing a treatment.
Eligibility criteria
Inclusion 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 * Healthy controls * 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). * Manifest carriers * 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 * Patients physically able to sign consent * Premanifest carriers * Number of GACs ≥ 40 * CAP score ≥250 * CFT = 13 * TMS \< 6 * Patients physically able to sign consent Exclusion Criteria: * Participant under guardianship or curatorship * 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) * 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 disease that may impact participant's performance * Chronic progressive neurological disease * Claustrophobia * Brain injury unrelated to HD * Pacemaker, intracorporeal metal, intracerebral clip * Pregnant, breastfeeding or wanting to procreate during participation in the study.
The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.
Eligibility criteria as of 2024-05-07