Status:
TERMINATED
iMagemHTT: FIH Evaluation of Novel Mutant Huntingtin PET Radioligands [¹¹C]CHDI-00485180-R and [¹¹C]CHDI-00485626
Lead Sponsor:
CHDI Foundation, Inc.
Collaborating Sponsors:
Universitaire Ziekenhuizen KU Leuven
Conditions:
Huntington Disease
Eligibility:
All Genders
20-65 years
Phase:
EARLY_PHASE1
Brief Summary
This is a FIH (first-in-human) adaptive PET (Positron Emission Tomography) imaging study to explore the binding and kinetic properties of two potential mutant huntingtin (mHTT) radioligands; \[¹¹C\]CH...
Detailed Description
The study investigators have developed two novel PET radioligands that will be evaluated for their suitability for use in clinical research settings to quantify mHTT in HDGECs. The PET radioligands do...
Eligibility Criteria
Inclusion
- Pre-manifest HDGECs, HDGECs with Stage I HD, HDGECs with Stage II HD and HC participants:
- Female and male adults, age 20-65 years old, inclusive.
- Body Mass Index (BMI) between 19 and 35 inclusive.
- Capacity to give full informed consent in writing, and have read and signed the informed consent form (ICF).
- Are capable of complying with study procedures, including fasting and blood sampling
- Able and willing to travel to imaging PET center in Leuven, Belgium.
- Willing to comply with the use of adequate contraceptive measures.
- Pre-manifest HDGECs:
- Do not have clinical diagnostic motor features of HD, defined as Unified Huntington's Disease Rating Scale (UHDRS) Diagnostic Confidence Score \< 4; and
- Have CAG expansion ≥ 40; and
- Have a CAP score \> 70 (as calculated with CAP formula: AGE \* (CAG - 30) / 6.49).
- HDGECs with Stage I HD:
- Have clinical diagnostic motor features of HD, defined as UHDRS Diagnostic Confidence Score = 4; and
- Have CAG expansion ≥ 40; and
- Have Stage I HD, defined as UHDRS Total Functional Capacity (TFC) scores between 11 and 13 inclusive.
- HDGECs with Stage II HD:
- Have clinical diagnostic motor features of HD, defined as UHDRS Diagnostic Confidence Score = 4; and
- Have CAG expansion ≥ 40; and Have Stage II HD, defined as UHDRS Total Functional Capacity (TFC) scores between 7 and 10 inclusive.
- HC participants:
- Have no known family history of HD; or
- Have known family history of HD but have been tested for the huntingtin gene glutamine codon (CAG) expansion and are not at genetic risk for HD (CAG \< 36).
- Matched by age +/- 5 years.
- (Phase 1 only) under 35 years of age.
Exclusion
- Pre-manifest HDGECs, HDGECs with Stage I HD, HDGECs with Stage II HD, and HC participants:
- Currently participating in or less than 30 days after completing participation in other therapeutic or imaging studies.
- Previous participation in PET imaging study that, cumulatively with the current study, will exceed annual regulatory limits for radiation exposure.
- 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 interpretation.
- Pregnant and breastfeeding females.
- Concomitant medication (ConMed) use of antiplatelet or anticoagulant therapy (inclusive of acetylsalicylic acid). (See full ConMed list attached.)
- Needle phobia.
- HDGEC participants:
- • If 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 to participation.
- HC participants:.
- • Family history of HD (unless genetic test confirming negative results).
- For participants in optional CSF sample collection:
- Frequent headache, significant lower spinal deformity or major surgery; or
- Bleeding disorder.
Key Trial Info
Start Date :
February 9 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 15 2023
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT03810898
Start Date
February 9 2021
End Date
February 15 2023
Last Update
May 6 2023
Active Locations (1)
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1
Universitaire Ziekenhuizen Leuven/ UZ Leuven/ UZL
Leuven, Belgium, 3000