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iMagemHTT: FIH Evaluation of Novel Mutant Huntingtin PET Radioligands [¹¹C]CHDI-00485180-R and [¹¹C]CHDI-00485626

NCT03810898 · Status: TERMINATED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2023-05-06

No results posted yet for this study

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; \[¹¹C\]CHDI-00485180-R and \[¹¹C\]CHDI-00485626.

The binding characteristics of these radioligands will be evaluated first in young (\< 35 years of age) healthy control (HC) participants (Phase 1a) and subsequently in young HCs and Huntington's disease gene-expansion carriers (HDGECs) with Stage II HD (Phase 1b). Subsequent phases will continue to explore the radioligands' binding characteristics in HDGECs with Stage II HD (Phase 2a), Stage I HD (Phase 2b) and pre-manifest HDGECs (Phase 2c) and their age matched healthy controls. All phases are cross-sectional and will include comparisons between HCs and HDGECs. Test-retest (TRT) evaluations will be done during Phase 2a, with the option of including further test-retests in Phases 2b, and 2c after review of data by the iMagemHTT Executive Committee. TRT is only applicable to HDGEC participants.

There are four planned interim analyses at which either radioligand may be dropped if its characteristics are shown to be suboptimal. If successful, the study will establish \[¹¹C\]CHDI-00485180-R and/or \[¹¹C\]CHDI-00485626 as fit for further development as drug development tools to measure mHTT levels in HDGECs. This development is intended to demonstrate the value of PET imaging with these radioligands as a disease progression biomarker, predictive biomarker, pharmacodynamic biomarker, and eventually as an efficacy biomarker.

All HDGEC participants will be invited to provide an optional cerebrospinal fluid (CSF) sample that will be collected after the imaging visits are complete. These samples will be processed to evaluate CSF mHTT levels and other potential biomarkers and to explore potential relationships between soluble CSF mHTT levels and mHTT binding identified by \[¹¹C\]CHDI-00485180-R and/or \[¹¹C\]CHDI-00485626 PET imaging. Potential CSF biomarkers that might be co-expressed or accumulated in HD may also be examined.

Conditions

  • Huntington Disease

Interventions

RADIATION

Radioligand [¹¹C]CHDI-00485180-R

Intravenous injection of radioligand in the arm with PET imaging of the brain.

RADIATION

Radioligand [¹¹C]CHDI-00485626

Intravenous injection of radioligand in the arm with PET imaging of the brain.

Sponsors & Collaborators

  • Universitaire Ziekenhuizen KU Leuven

    collaborator OTHER

  • CHDI Foundation, Inc.

    lead OTHER

Principal Investigators

  • Wim Vandenberghe, MD, PhD · Universitaire Ziekenhuizen Leuven/ UZ Leuven/ UZL

  • Mette Skinbjerg, PhD · CHDI Management/ CHDI Foundation

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
20 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-02-09
Primary Completion
2023-02-15
Completion
2023-02-15

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03810898 on ClinicalTrials.gov