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New treatment option for Huntington Disease
Official title Innovative Imaging and Cognitive BIOmarkers to Predict Huntington's Disease Progression
ClinicalTrials.gov ID: NCT05808153
What this study is testing
- What it's testing
- Intro Huntington's disease (HD) patients suffer from motor, cognitive and behavioral impairments, with heterogeneous phenotypes and variable time course. This leads to a high variance of HD markers, none of which is currently sensitive enough to 1) measure disease progression from small cohort data, 2) predict disease entry in carriers of the HD mutation (during the prodromal phase or in patients considered asymptomatic: pre-HD patients), and 3) measure a significant evolution of the state of pre-HD patients over a time window compatible with the realization of clinical trials (about 2/3 years).
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65. Healthy volunteers may be eligible.
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
- Healthy controls
You likely can't join if
- 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
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
- 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
- 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...
- 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...
- 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 treatment 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 study team makes the final eligibility decision.
Where it's taking place
- Créteil, Île-de-France Region, France
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 years to 65 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Créteil, Île-de-France Region, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.