Phase 2
N=142
Long-Term Dopamine Transporter Imaging and Clinical Assessment of Parkinson's Disease Progression
Parkinson Disease
Bottom Line
View on ClinicalTrials.gov: NCT00134784 ↗Enrolled (actual)
142
Serious AEs
0.0%
Results posted
Aug 2014
Primary outcome: Primary: Change in the Ratio of the Specific Striatal [123I]B-CIT Uptake to the Nondisplaceable Striatal [123I]B-CIT Uptake Between the Two Images — -2.6; -4.7; -3.7; -6.9 percent change of B-CIT Uptake
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- [123I]B-CIT SPECT imaging (Drug)
- Age
- Adult, Older Adult · 22+ yrs
- Sex
- All
- Sponsor
- Institute for Neurodegenerative Disorders
- Primary completion
- May 2007
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in the Ratio of the Specific Striatal [123I]B-CIT Uptake to the Nondisplaceable Striatal [123I]B-CIT Uptake Between the Two Images |
-2.6; -4.7; -3.7; -6.9 | — |
Summary
The purpose of this project is to assess the change in dopamine transporter density in Parkinson's disease subjects during a sixty month period including a nine month treatment trial of levodopa. Dopamine transporter will be assessed using [123I]ß-CIT SPECT (single photon emission computed tomography) imaging, a marker of dopamine terminal integrity and of clinical disease state.
Eligibility Criteria
Inclusion Criteria
- Prior participation in the study titled Dopamine Transporter Imaging Assessment of Parkinson's Disease Progression (DAMD17-99-1-9472) [123I] B-CIT and Spect in Vivo Imaging Assessment of Dopamine Transporter Density in Subjects With Early Parkinson's Disease Participating in Earlier Vs. Later Levodopa in Parkinson's Disease (ELLDOPA)].
Exclusion Criteria
- Inability to sign informed consent and participate in all study procedures.
- Mini mental status exam < 25.
- Pregnancy
Data sourced from ClinicalTrials.gov (NCT00134784). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.