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| Name | Class |
|---|---|
| United States Department of Defense | FED |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Assess [123I]B-CIT SPECT imaging | Experimental | To assess[123I]B-CIT SPECT imaging in early Parkinson's disease subjects on placebo compared to early verses later Levodopa. Subjects on Levodopa 150mg/day, Levodopa 300 mg/day, and Levodopa 600 mg/day will be assessed. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [123I]B-CIT SPECT imaging | Drug | To assess [123I]B-CIT SPECT imaging |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 40 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kenneth L Marek, MD | Institute for Neurodegenerative Disorders | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15590952 | Result | Fahn S, Oakes D, Shoulson I, Kieburtz K, Rudolph A, Lang A, Olanow CW, Tanner C, Marek K; Parkinson Study Group. Levodopa and the progression of Parkinson's disease. N Engl J Med. 2004 Dec 9;351(24):2498-508. doi: 10.1056/NEJMoa033447. |
| Label | URL |
|---|---|
| Institute for Neurodegenerative Disorders | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Placebo group |
| FG001 | Levodopa 150mg/Day | Levodopa 150mg/day, [123I]ß-CIT and SPECT imaging |
| FG002 | Levodopa 300 mg/Day | Levodopa 300mg/day, [123I]ß-CIT and SPECT imaging |
| FG003 | Levodopa 600 mg/Day | Levodopa 600/day, [123I]ß-CIT and SPECT imaging |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo Group | Subjects on placebo |
| BG001 | Levodopa 150mg/Day | Subjects on 150mg/day of Levodopa |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Per protocol | Posted | Oct 2010 | Mean | Standard Deviation | percent change of B-CIT Uptake | 40 weeks | B-CIT Uptake | Participants |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | I123BCIT | [123I]ß CIT and SPECT imaging' . |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Principal Investigator | Institute for Neurodegenerative Disorders | 203 401 4300 | kmarek@indd.org |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| BG002 |
| Levodopa 300 mg/Day |
Subjects on 300 mg/day of Levodopa |
| BG003 | Levodopa 600 mg/Day | Subjects on Levodopa 600 mg/day |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex/Gender, Customized | Number | participants |
|
| OG002 | Levodopa 2 | Subjects on 300 mg/day of Levodopa |
| OG003 | Levodopa 3 | Subjects on 600 mg/day of Levodopa |
|
|
| 0 |
| 142 |
| 0 |
| 142 |
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| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |