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New treatment option for Huntington Disease
Official title iMagemHTT-009- FIH Evaluation of Novel Mutant Huntingtin PET Radioligand [11C]CHDI-00491009
ClinicalTrials.gov ID: NCT06634628
What this study is testing
- What it's testing
- This is a FIH (first-in-human) study to evaluate the clinical utility of the radioligand [11C]CHDI-00491009 as a PET tracer that binds specifically to mutant huntingtin (mHTT) aggregates in Huntington's disease (HD). The study is divided into three cohorts defined by the Huntington's Disease Integrated Staging System (HD-ISS): Cohort 1 - initial tracer validation (3 healthy controls (HCs)); Cohort 2 - target validation and test-retest variability (6 HD-ISS Stage 3 participants and 6 age and biological sex-matched HCs); Cohort 3 - target sensitivity (6 HD-ISS Stage 2 participants and 6 age and biological sex-matched HCs).
- Phase 1: an early, usually small safety study
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 64. Healthy volunteers may be eligible.
You may be able to join if
- PwHD HD-ISS Stages 2 and 3 and HC participants who:
- Are female or male adults, age 18-64 years old, inclusive.
- Have body mass index (BMI) between 19 and 35, inclusive.
- Have capacity to give full informed consent in writing and have read and signed the informed consent form (ICF).
- Are able to comply with study procedures, including fasting and blood sampling.
You likely can't join if
- PwHD HD-ISS Stages 2 and 3 and HC participants who:
- Are currently participating in, or are less than 30 days after completing participation in, other therapeutic or imaging studies.
- Have previously participated in a PET imaging study in the past 12 months that, cumulatively with the current study, will exceed annual regulatory...
- Have any disease, condition, or concomitant medication that significantly compromises the function of the body systems and that, in the opinion of...
- Are pregnant and breastfeeding females.
- Have concomitant use of antiplatelet or anticoagulant therapy (inclusive of acetylsalicylic acid).
See the full eligibility criteria
- PwHD HD-ISS Stages 2 and 3 and HC participants who:
- Are female or male adults, age 18-64 years old, inclusive.
- Have body mass index (BMI) between 19 and 35, inclusive.
- Have capacity to give full informed consent in writing and have read and signed the informed consent form (ICF).
- Are able to comply with study procedures, including fasting and blood sampling.
- Are able and willing to travel to the imaging center in Leuven, Belgium.
- Are willing to comply with the use of adequate contraceptive measures. HD-ISS Stage 2 participants who:
- Have a huntingtin gene CAG expansion between 40 and 50, inclusive; and
- Are classified within HD-ISS Stage 2 per the HD-ISS criteria using HD-ISS Modified Stage calculator.
- Have a PIN score of 0.47 to 1.84 [prognostic index normed for HD (PIN) where PIN = (PIHD - 883)/1044 where PIHD = 51 x TMS + (-34) x SDMT + 7 x Age x (CAG - 34) (TMS is the UHDRS Total Motor Score, and SDMT is the UHDRS...
- PwHD HD-ISS Stages 2 and 3 and HC participants who:
- Are currently participating in, or are less than 30 days after completing participation in, other therapeutic or imaging studies.
- Have previously participated in a PET imaging study in the past 12 months that, cumulatively with the current study, will exceed annual regulatory limits for radiation exposure.
- Have any disease, condition, or concomitant medication that significantly compromises the function of the body systems and that, in the opinion of the Investigator, might interfere with the conduct of the study or its...
- Are pregnant and breastfeeding females.
- Have concomitant use of antiplatelet or anticoagulant therapy (inclusive of acetylsalicylic acid).
- Have a bleeding disorder.
- Have a needle phobia.
- Have any metal objects present in the body that are incompatible with MRI.
- Have metal objects present in the body that are compatible with MRI and are located in the head or neck.
- Have any clinically significant results on safety laboratory tests that, in the opinion of the Investigator, would either put the participant at risk or interfere with the conduct of the study or interpretation of data...
- a. positive results for HBsAg, HepC, HIV-1 or HIV-2 (will also be reported as required by local/national regulations),
- b. clinically significant, abnormal results for safety laboratory tests. PwHD participants who:
- If they are using any antidepressant, psychoactive, psychotropic or other medications or nutraceuticals used to treat HD, the use of inappropriate (e.g., non-therapeutically high) or unstable dose within 30 days prior...
- Have a family history of HD and have not been tested for the huntingtin gene (CAG) expansion.
The study team makes the final eligibility decision.
Where it's taking place
- Leuven, Belgium
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 64 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Leuven, Belgium. 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.