Using new imaging and cognitive biomarkers to predict progression in Huntington's disease
Innovative Imaging and Cognitive BIOmarkers to Predict Huntington's Disease Progression
This study is testing new imaging and brain function markers to see if they can help predict how Huntington's disease will progress in people who have it and those who might get it in the future.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Créteil, Île-de-France Region) |
| Trial ID | NCT05808153 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the sensitivity of innovative imaging and cognitive biomarkers in predicting the progression of Huntington's disease (HD) in both symptomatic and presymptomatic patients. By utilizing radiotracer injections, the researchers will assess the effectiveness of these new markers in measuring disease progression and stratifying patients for future clinical trials. The study seeks to establish a model of disease progression and improve patient selection strategies for therapeutic interventions. Participants will include both manifest and premanifest carriers of the HD mutation, as well as healthy controls.
Who should consider this trial
Good fit: Ideal candidates for this study include adults aged 18 to 65 who are either symptomatic or presymptomatic carriers of the Huntington's disease mutation.
Not a fit: Patients with unrelated neurological or psychiatric disorders, or those under guardianship, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more accurate predictions of Huntington's disease progression, enabling better patient management and targeted therapies.
How similar studies have performed: While this approach is innovative, similar studies have shown promise in utilizing biomarkers for disease progression in other neurodegenerative conditions.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Créteil, Île-de-France Region
- Hopital Henri MONDOR — Créteil, Île-de-France Region, France (Recruiting)
Study contacts
- Study coordinator: Anne-Catherine BACHOUD-LEVI, PhD
- Email: anne-catherine.bachoud-levi@aphp.fr
- Phone: (+33)1 49 81 23 10
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.