Ignite Creation Date:
2024-05-05 @ 11:45 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00129675
Status:
COMPLETED
Last Update Posted:
2014-07-16
First Post:
2005-08-11
Brief Title:
Study of Individuals With Parkinsons Symptoms But in Whom There is Diagnostic Uncertainty
Sponsor:
Institute for Neurodegenerative Disorders
Organization:
Institute for Neurodegenerative Disorders
Study Overview
Official Title:
Development of a Imaging Marker for Parkinsons Disease Through Use of Dynamic SPECT Imaging With 123I Beta-CIT in Individuals With Parkinsons Symptoms
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:
None
Brief Summary:
The overall goal of this study is to evaluate the use of dopamine transporter DAT imaging as a diagnostic tool in subjects with early parkinsonian symptoms in whom Parkinsons disease PD or parkinsonian syndrome PS is suspected but the diagnosis remains unclear from a clinical standpoint
Detailed Description:
Subjects will be referred to the Institute for Neurodegenerative Disorders IND by practicing general neurologists with genuine uncertainty regarding the subjects diagnosis
Subjects with suspected PD or PS will be evaluated clinically and with DAT imaging using b-CIT and SPECT The DAT imaging procedure will take place over two days
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 asked to return within 3 months following the imaging study to have a repeat neurological examination by the two study neurologists at IND
Subjects will be asked to return at about 6 months and possibly again at one year following the imaging study for a final clinical evaluation by one of the study neurologists at IND
Subjects with suspected PD or PS will be evaluated clinically and with DAT imaging using b-CIT and SPECT The DAT imaging procedure will take place over two days
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 asked to return within 3 months following the imaging study to have a repeat neurological examination by the two study neurologists at IND
Subjects will be asked to return at about 6 months and possibly again at one year following the imaging study for a final clinical evaluation by one of the study neurologists at IND
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