iMagemHTT

FIH Evaluation of Novel Mutant Huntingtin (HTT) PET Radioligands [¹¹C]CHDI-00485180-R and [¹¹C]CHDI-00485626

Recruiting

ABOUT

SPONSOR

CHDI Foundation, Inc.

PARTICIPANTS

84

The main purpose of this study is to identify whether so-called radioligands (small radioactive particles) can detect mutant Huntingtin (mHTT) in the brain. This imaging study is done on humans and uses PET scans (images) of the brain to see if the presence of radioligands corresponds with the expression of mutant huntingtin in brain cells. The objective of the study is to use PET scans of radioligands to measure the presence of mHTT in brain cells. If proven valid and to be an effective way to measure mHTT, it can be used to measure if huntingtin lowering therapies actually lower mHTT in the brain. This study is important and needs volunteers because we still don’t have any methods to measure whether the huntingtin lowering therapies actually gets into the brain tissue where it’s needed and whether the mHTT levels are lowered

Estimated Study Completion Date: January 2023

Ages Eligible for Study:

20 Years to 65 Years (Adult, Older Adult)

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria

Pre-manifest Huntington’s disease gene-expansion carriers, gene carriers with Stage I Huntington’s disease, gene carriers with Stage II Huntington’s disease and healthy control 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 Huntington’s disease gene-expansion carriers:

  • 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).

Gene carriers with Stage I Huntington’s disease:

  • 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.

Gene carriers with Stage II Huntington’s disease:

  • 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.

Healthy control 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 Criteria

Pre-manifest Huntington’s disease gene-expansion carriers, gene carriers with Stage I Huntington’s disease, gene carriers with Stage II Huntington’s disease and healthy control 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.

Huntington’s disease gene-expansion carriers 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.

Healthy control participants:

  • Family history of Huntington’s disease (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.

CONTACT

Illona Feldman
Tel.: 609-945-9629
illona.feldman@chdifoundation.org

BELGIUM

TRIAL SITE:
Universitaire Ziekenhuizen Leuven/ UZ Leuven/ UZL

Address: Leuven, Belgium, 3000

CONTACT
Wim Vandenberghe
Tel: 32 16344280
wim.vandenberghe@uzleuven.be  

Koen Van Laere
Tel: 32 16 34 37 11
koen.vanlaere@uzleuven.be

Recruiting