The aim of this study is to measure the availability of the PDE10A enzyme in Huntington disease gene expansion carriers (HDGECs) using the recently developed radioligand \[18F\]MNI-659. The study will be cross-sectional, examining HDGECs at different stages of the disease (pre-manifest, stage 1 and stage 2), in comparison with Healthy Controls (HCs). The HDGECs included in this study will be recruited from the large database of the REGISTRY (NCT01590589) or ENROLL-HD (NCT01574053) studies.
The study will be organized in an "adaptive-like" mode. Initially a cohort of 5 HDGECs and 5 HCs will be studied. The data obtained in the first cohort will be analysed and depending on the variability of the data, there will be approximately 10 HDGECs and an equal number of HCs in the second cohort and the size of the third cohort may be altered to in total include approximately 45 HDGECs and an equal number of HCs.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
90
The radioligands \[11C\]raclopride and \[18F\]MNI-659 will be administered at doses less than 10 micrograms, i.e. within the micro dosing concept, and no pharmacological effects are expected. The injected radioactivity of \[11C\]raclopride will be 300 MBq/70 kg of body weight ± 10%. The injected radioactivity of \[18F\]MNI-659 will be 185 MBq/70 kg of body weight ± 10%.
The Memory Clinic, Rigshopitalet
Copenhagen, Denmark
Leiden University Medical Center, Department of Neurology
Leiden, Netherlands
University of Oslo, Nevrologisk poliklinikk
Oslo, Norway
Skane Universitetssjukhus Lund, Neurologiska kliniken
Lund, Sweden
The primary outcome measure will be the distribution volume (VT) in the striatum (caudate and putamen), globus pallidus, and ventral striatum estimated using kinetic and graphical analysis. Thalamus, cortex and cerebellum will also be examined.
Time frame: Visit 3: For HD subjects, this will occur within 90 days from the Screening Visit. For Healthy Controls, this will occur within 28 days of Screening visit.
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Karolinska Universitetssjukhus, Huddinge
Stockholm, Sweden
Karolinska University Hospital
Stockholm, Sweden
KTA Karolinska Trial Alliance
Stockholm, Sweden
Neurologkliniken Akademiska sjukhuset, ing 85
Uppsala, Sweden