NCT02061722

[PETDE10] Imaging of PDE10A Enzyme Levels in Huntington's Disease Gene Expansion Carriers and Healthy Controls With PET.

[PETDE10] Imaging of Phosphodiesterase 10 A (PDE10A) Enzyme Levels in the Living Human Brain of Huntington´s Disease Gene Expansion Carriers and Healthy Controls With Positron Emission Tomography

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 90 (actual)
• Sponsor: CHDI Foundation, Inc. · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Huntington's Disease

Interventions

Type	Name	Description
RADIATION	PET Imaging with [18F]MNI-659	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%.

Timeline

• Start date: 2013-01-01
• Primary completion: 2016-05-01
• Completion: 2016-05-01
• First posted: 2014-02-13
• Last updated: 2016-06-01

Locations

8 sites across 4 countries: Denmark, Netherlands, Norway, Sweden