iMagemHTT-009- FIH Evaluation of Novel Mutant Huntingtin PET Radioligand [11C]CHDI-00491009

Recruiting Early Phase 1 Interventional Study
Huntington Disease HD PET Tracer Positron Emission Tomography Radioligand Imaging mHTT Huntington's Huntington's Disease
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Healthy Volunteers Welcome You do not need to have the condition being studied to take part.
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At a Glance
Age
18 – 64
Sex
Any
Trial phase
Early Phase 1
Study type
Interventional
Purpose
Other
Participants needed
27 (estimated)
Sponsor
CHDI Foundation, Inc. · Other
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About This Trial
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)); Coh…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: PwHD HD-ISS Stages 2 and 3 and HC participants who: 1. Are female or male adults, age 18-64 years old, inclusive. 2. Have body mass index (BMI) between 19 and 35, inclusive. 3. Have capacity to give full informed consent in writing and have read and signed the informed consent …
Contacts

Wim Vandenberghe, MD, PhD

+32 16344280

wim.vandenberghe@uzleuven.be

CONTACT