Parkinson Disease
Conditions
Keywords
parkinson, brain imaging
Brief 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.
Detailed description
All subjects will be imaged at the Institute for Neurodegenerative Disorders. Subjects will be evaluated sequentially with \[123I\]ß-CIT SPECT and standardized clinical rating scales during a sixty month period. The subjects involved in this study will have had \[123I\]ß-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 \[123I\]ß-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.
Interventions
DRUG[123I]B-CIT SPECT imaging
To assess \[123I\]B-CIT SPECT imaging
Sponsors
United States Department of Defense
Institute for Neurodegenerative Disorders
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in the Ratio of the Specific Striatal [123I]B-CIT Uptake to the Nondisplaceable Striatal [123I]B-CIT Uptake Between the Two Images | 40 weeks | The use of SPECT to measure striatal dopamine-transporter density with the use of \[123I\]B-CIT. Subjects underwent SPECT imaging just before the baseline visit and then again before the visit at week 40. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Placebo Group Subjects on placebo | 29 |
| Levodopa 150mg/Day Subjects on 150mg/day of Levodopa | 38 |
| Levodopa 300 mg/Day Subjects on 300 mg/day of Levodopa | 37 |
| Levodopa 600 mg/Day Subjects on Levodopa 600 mg/day | 38 |
| Total | 142 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Withdrawal by Subject | 2 | 2 | 2 | 1 |
Baseline characteristics
| Characteristic | Total | Placebo Group | Levodopa 150mg/Day | Levodopa 300 mg/Day | Levodopa 600 mg/Day |
|---|---|---|---|---|---|
| Age, Continuous Age of Subject in Years | 63.4 years STANDARD_DEVIATION 10.6 | 63.9 years STANDARD_DEVIATION 10.5 | 64.5 years STANDARD_DEVIATION 11.8 | 63.1 years STANDARD_DEVIATION 10.2 | 62.3 years STANDARD_DEVIATION 9.8 |
| Sex/Gender, Customized Female | 41 participants | 7 participants | 15 participants | 8 participants | 11 participants |
| Sex/Gender, Customized Male | 101 participants | 22 participants | 23 participants | 29 participants | 27 participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 142 |
| serious Total, serious adverse events | 0 / 142 |
Outcome results
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
The use of SPECT to measure striatal dopamine-transporter density with the use of \[123I\]B-CIT. Subjects underwent SPECT imaging just before the baseline visit and then again before the visit at week 40.
Time frame: 40 weeks
Population: Per protocol
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo Group | 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 percent change of B-CIT Uptake | Standard Deviation 11.3 |
| Levodopa | Change in the Ratio of the Specific Striatal [123I]B-CIT Uptake to the Nondisplaceable Striatal [123I]B-CIT Uptake Between the Two Images | -4.7 percent change of B-CIT Uptake | Standard Deviation 10.8 |
| Levodopa 2 | Change in the Ratio of the Specific Striatal [123I]B-CIT Uptake to the Nondisplaceable Striatal [123I]B-CIT Uptake Between the Two Images | -3.7 percent change of B-CIT Uptake | Standard Deviation 9.1 |
| Levodopa 3 | Change in the Ratio of the Specific Striatal [123I]B-CIT Uptake to the Nondisplaceable Striatal [123I]B-CIT Uptake Between the Two Images | -6.9 percent change of B-CIT Uptake | Standard Deviation 8.1 |