At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 142 enrolled
Drug / intervention
[123I]B-CIT SPECT imagingdrug
Likely dose
Not stated in record
Key inclusion· 1
- ✓Prior enrollment in the ELLDOPA trial (Dopamine Transporter Imaging Assessment of Parkinson's Disease Progression DAMD17-99-1-9472)
Key exclusion· 2
- ✕Mini-Mental State Examination score less than 25
- ✕Pregnancy
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
[123I]ß-CIT and SPECT in Vivo Three Year Imaging Assessment of Dopamine Transporter Density in Subjects With Early Parkinson's Disease Participating in Earlier vs. Later Levodopa in Parkinson's Disease
In Brief
A Phase 2 clinical trial evaluating [123I]B-CIT SPECT imaging for Parkinson Disease. Completed, enrolled 142 participants.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsParkinson Disease
Countries--
CollaboratorsUnited States Department of Defense
Timeline
Phase 2CompletedFinished
2000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartApr 2000
First PostedAug 2005
Primary CompletionMay 2007
TodayJul 2026
First PostedAug 25, 2005
Enrollment StartApr 1, 2000
Primary CompletionMay 1, 2007
TodayJul 2, 2026
Enrollment to primary: 7.1 yearsPosted 20.9 years ago
Interventions
[123I]B-CIT SPECT imagingdrug
To assess \[123I\]B-CIT SPECT imaging