Ignite Creation Date:
2024-05-05 @ 12:08 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00250172
Status:
COMPLETED
Last Update Posted:
2019-12-16
First Post:
2005-11-05
Brief Title:
PET Whole Body Biodistribution and Test Retest Bain Imaging Studies Using a Phosphodiesterase 4 Inhibitor R-11CRolipram
Sponsor:
National Institute of Mental Health NIMH
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
PET Whole Body Biodistribution and Test Retest Brain Imaging Studies Using a Phosphodiesterase 4 Inhibitor R-11CRolipram
Status:
COMPLETED
Status Verified Date:
2014-09-15
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:
None
Brief Summary:
The purpose of this study is to measure a particular protein in the brain called the phosphodiesterase by using the imaging techniques of positron emission tomography PET and magnetic resonance imaging MRI
Detailed Description:
Both basic and clinical studies have indicated that the 3 5-cyclic adenosine monophosphate cAMP system plays critical roles in several brain diseases particularly in mood disorders and drug addiction cAMP is synthesized from adenosine 5-triphosphate ATP by adenylyl cyclase and metabolized by cyclic nucleotide phosphodiesterases PDEs Among components of the cAMP pathway PDE4 appears to be critical for antidepressant effects 4-3-cyclopentoxyl-4-methoxyphenyl-2-pyrrolidone rolipram is an inhibitor of PDE4 As a positron emission tomography PET brain imaging agent rolipram has good properties such as high affinity of 1-2 nM and appropriate lipophilicity Log P of 3 A rat study gave an estimation of low radiation absorbed doses of the active enantiomer R-11Crolipram ciociWEge quality Therefore R-11Crolipram is a promising PET ligand However radiation absorbed doses have not been estimated from human whole body imaging studies and a method to measure binding of R-11Crolipram in human brain has not been established
TAB
The purposes of this protocol are to estimate radiation absorbed doses of R-11Crolipram by performing whole body imaging studies on healthy human subjects and also to establish an accurate method to measure PDE4 levels in brain by performing test retest brain imaging studies The results of this overall study are required to apply this PET ligand in various neurological and psychiatric disorders in the future
TAB
The purposes of this protocol are to estimate radiation absorbed doses of R-11Crolipram by performing whole body imaging studies on healthy human subjects and also to establish an accurate method to measure PDE4 levels in brain by performing test retest brain imaging studies The results of this overall study are required to apply this PET ligand in various neurological and psychiatric disorders in the future
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 06-M-0002 | None | None | None |