Ignite Creation Date:
2024-05-06 @ 2:31 AM
Last Modification Date:
2024-10-26 @ 11:19 AM
Study NCT ID:
NCT02061722
Status:
COMPLETED
Last Update Posted:
2016-06-01
First Post:
2014-02-03
Brief Title:
PETDE10 Imaging of PDE10A Enzyme Levels in Huntingtons Disease Gene Expansion Carriers and Healthy Controls With PET
Sponsor:
CHDI Foundation Inc
Organization:
CHDI Foundation Inc
Study Overview
Official Title:
PETDE10 Imaging of Phosphodiesterase 10 A PDE10A Enzyme Levels in the Living Human Brain of Huntingtons Disease Gene Expansion Carriers and Healthy Controls With Positron Emission Tomography
Status:
COMPLETED
Status Verified Date:
2016-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PEARL-HD
Brief 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 18FMNI-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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None