Follow-up Measurement of Brain PDE10A Enzyme Levels in Huntington´s Disease Gene Expansion Carriers (LONGPDE10)
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|ClinicalTrials.gov Identifier: NCT02956148|
Recruitment Status : Completed
First Posted : November 7, 2016
Last Update Posted : September 6, 2018
|Condition or disease||Intervention/treatment||Phase|
|Huntington's Disease||Radiation: Radioligand [18F]MNI-659||Early Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||45 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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)|
|Actual Study Start Date :||September 6, 2015|
|Actual Primary Completion Date :||March 10, 2017|
|Actual Study Completion Date :||March 10, 2017|
Experimental: Radioligand [18F]MNI-659
All subjects will receive a single intravenous dose of the radioligand [18F]MNI-659 (investigational medicinal product [IMP]) and undergo PET imaging.
The radioligand [18F]MNI-659 will be administered at a dose of less than 5 micrograms, i.e. within the micro dosing concept, and no pharmacological effects are expected.
The injected radioactivity of [18F]MNI-659 will be 185 MBq/70 kg of body weight ± 10%.
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.
- The longitudinal changes of PDE10A enzyme availability in the caudate, putamen, and globus pallidus of Huntington's Disease Gene Expansion Carriers by comparison of the follow-up and initial PET measurements. [ Time Frame: The follow up PET measurement can be performed from 18 to 28 months after the initial PET measurement that was performed in the CHDIKI/PET-HD-PDE10A Study ]The HDGECs will perform 2 study visits; Visits 1 (screening) and Visit 2 (PET) and 2 telephone follow ups, one after Visit 1 (telephone follow-up after screening) and one after Visit 2, (telephone follow-up after PET) 18 to 28 months after the initial PET measurement conducted in the CHDIKI1201/PET-HD-PDE10A study. An individual subject's participation in this study will last for a maximum of 97 days
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02956148
|The Memory Clinic, Rigshopitalet|
|Leiden University Medical Center, Department of Neurology|
|Leiden, Netherlands, K5Q112|
|University of Oslo, Nevrologisk poliklinikk|
|Oslo, Norway, 0372 Oslo|
|Skane Universitetssjukhus Lund, Neurologiska kliniken|
|Lund, Sweden, SE-221 85|
|Karolinska Universitetssjukhus, Huddinge|
|Stockholm, Sweden, SE-141 86|
|Karolinska University Hospital|
|Stockholm, Sweden, SE-171 76|
|Uppsala University Hospital|
|Principal Investigator:||Andrea Varrone, MD, PhD||Karolinska University Hospital|
|Study Director:||Cristina Sampaio, MD, PhD||CHDI Foundation, Inc.|