NCT02956148

Follow-up Measurement of Brain PDE10A Enzyme Levels in Huntington´s Disease Gene Expansion Carriers

Follow-up Measurement of Brain Phosphodiesterase 10 A (PDE10A) Enzyme Levels in Huntington´s Disease Gene Expansion Carriers, 18 to 28 Months After Initial Positron Emission Tomography (PET) Measurement in CHDIKI1201/PET-HD-PDE10A (NCT02061722)

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: CHDI Foundation, Inc. · Academic / Other
• Sex: All
• Age: 18 Years – 73 Years
• Healthy volunteers: Not accepted

Summary

The aim of this study is to measure longitudinally the availability of the PDE10A enzyme in HDGECs using the radioligand \[18F\]MNI-659. The study will be a follow-up, examining HDGECs from the CHDIKI1201/PET-HD-PDE10A (NCT02061722) study from 18 to 28 months after the initial PET measurement.

Detailed description

The HDGECs will perform 2 study visits: Visit 1 (screening) and Visit 2 (PET analysis utilizing the radioligand \[18F\]MNI-659). There will also be 2 telephone follow ups; one after Visit 1 (telephone follow-up after screening) and one after Visit 2, (telephone follow-up after PET). Study visits and telephone follow-ups will take place during a maximum of 97 days.

Conditions

• Huntington's Disease

Interventions

Type	Name	Description
RADIATION	Radioligand [18F]MNI-659	The effective radiation dose for the injection of \[18F\]MNI-659 is approximately 5.6 mSv (approximately 2 years of background radiation in Sweden) for an average person weighing 70 kg.

Timeline

• Start date: 2015-09-06
• Primary completion: 2017-10-05
• Completion: 2017-10-05
• First posted: 2016-11-07
• Last updated: 2019-10-10

Locations

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