Using new imaging and cognitive biomarkers to predict progression in Huntington's disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Pridopidine for Huntington's Disease: a 1-year, randomized, placebo-controlled study

  This trial tests whether pridopidine can slow the progression of Huntington's disease in adults compared with placebo over one year.

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• Low-intensity focused ultrasound targeting the globus pallidus to improve movement in Huntington's disease

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• Safety and tolerability of human neural stem cell implants for Huntington's disease

  This research will test whether an implant of hNSC-01 human neural stem cells is safe and tolerable for adults with Huntington's disease.

  Recruiting Phase 1/2 University of California, Irvine · Irvine, California · NCT07451613

• SKY-0515 for adults with Huntington's disease

  This trial will test whether the oral drug SKY-0515 can lower harmful huntingtin protein and improve symptoms in adults aged 25 and older with genetically confirmed Huntington's disease.

  Recruiting at 19 sites Phase 2/3 Skyhawk Therapeutics, Inc. · Englewood, Colorado and 30 other locations · NCT07378644

• Votoplam for adults with early symptomatic Huntington's disease

  This trial will test whether votoplam (HTT227) is safe and can slow disease progression in adults with early symptomatic Huntington's disease.

  Recruiting at 117 sites Phase 3 Novartis · Birmingham, Alabama and 116 other locations · NCT07326709

• Comparing three social cognition tests in adults with early Huntington disease

  This project will test whether the DMASC-MC and two established social cognition tests can detect social thinking problems in adults with early Huntington disease.

  Recruiting Region Skane · Lund · NCT07253038

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.