Ignite Creation Date:
2024-05-05 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00134784
Status:
COMPLETED
Last Update Posted:
2014-08-08
First Post:
2005-08-23
Brief Title:
Long-Term Dopamine Transporter Imaging and Clinical Assessment of Parkinsons Disease Progression
Sponsor:
Institute for Neurodegenerative Disorders
Organization:
Institute for Neurodegenerative Disorders
Study Overview
Official Title:
123Iß-CIT and SPECT in Vivo Three Year Imaging Assessment of Dopamine Transporter Density in Subjects With Early Parkinsons Disease Participating in Earlier vs Later Levodopa in Parkinsons Disease
Status:
COMPLETED
Status Verified Date:
2014-07
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:
ELLDOPA
Brief Summary:
The purpose of this project is to assess the change in dopamine transporter density in Parkinsons disease subjects during a sixty month period including a nine month treatment trial of levodopa Dopamine transporter will be assessed using 123Iß-CIT SPECT single photon emission computed tomography imaging a marker of dopamine terminal integrity and of clinical disease state
Detailed Description:
All subjects will be imaged at the Institute for Neurodegenerative Disorders
Subjects will be evaluated sequentially with 123Iß-CIT SPECT and standardized clinical rating scales during a sixty month period The subjects involved in this study will have had 123Iß-CIT and SPECT scans at baseline and return for scanning at week 40 following the start of their participation in the ELLDOPA study
Before each SPECT procedure subjects will be tested to ensure eligibility for the study They will also have a neurological evaluation including tests of motor function thinking memory and handwriting Some of these tests will be given with the aid of a computer
On the first day participants are injected with 123Iß-CIT an investigational radioactive material that localizes in the brain Study participants will also have a thorough neurologic examination and standard neuropsychological testing including testing of memory concentration abstraction and visual spatial functions
Twenty-four hours later study participants return to the Institute for Neurodegenerative Disorders where an investigational scanning procedure will be used to obtain SPECT single photon emission computed tomography images of the brain
Subjects will be evaluated sequentially with 123Iß-CIT SPECT and standardized clinical rating scales during a sixty month period The subjects involved in this study will have had 123Iß-CIT and SPECT scans at baseline and return for scanning at week 40 following the start of their participation in the ELLDOPA study
Before each SPECT procedure subjects will be tested to ensure eligibility for the study They will also have a neurological evaluation including tests of motor function thinking memory and handwriting Some of these tests will be given with the aid of a computer
On the first day participants are injected with 123Iß-CIT an investigational radioactive material that localizes in the brain Study participants will also have a thorough neurologic examination and standard neuropsychological testing including testing of memory concentration abstraction and visual spatial functions
Twenty-four hours later study participants return to the Institute for Neurodegenerative Disorders where an investigational scanning procedure will be used to obtain SPECT single photon emission computed tomography images of the brain
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