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Long-Term Dopamine Transporter Imaging and Clinical Assessment of Parkinson's Disease Progression (ELLDOPA)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00134784
First Posted: August 25, 2005
Last Update Posted: August 8, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
United States Department of Defense
Information provided by (Responsible Party):
Kenneth Marek, MD, Institute for Neurodegenerative Disorders
August 23, 2005
August 25, 2005
October 7, 2010
August 8, 2014
August 8, 2014
April 2000
May 2007   (Final data collection date for primary outcome measure)
Change in the Ratio of the Specific Striatal [123I]B-CIT Uptake to the Nondisplaceable Striatal [123I]B-CIT Uptake Between the Two Images [ Time Frame: 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.
To assess the rate of change in striatal [123I]ß-CIT uptake in a cohort of early Parkinson’s disease patients.
Complete list of historical versions of study NCT00134784 on ClinicalTrials.gov Archive Site
Not Provided
  • - To assess the effect of levodopa treatment on the rate of change in striatal [123I]ß-CIT uptake in a cohort of early Parkinson’s disease patients.
  • 2) To determine whether the rate of reduction in 123I]ß-CIT uptake in sequential SPECT imaging during a sixty month interval will correlate with the dopamine transporter density measured in the first scan. Is the rate of progression in early Parkinson�
  • 3) To determine whether the rate of reduction in [123I]ß-CIT uptake in sequential SPECT imaging during a sixty month interval will correlate with changes in the clinical measures of severity of disease.
  • 4) To determine cognitive changes in Parkinson’s Disease and correlate those changes with objective imaging measures of dopaminergic degeneration.
Not Provided
Not Provided
 
Long-Term Dopamine Transporter Imaging and Clinical Assessment of Parkinson's Disease Progression
[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
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.

Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Parkinson Disease
Drug: [123I]B-CIT SPECT imaging
To assess [123I]B-CIT SPECT imaging
Other Name: [123I]B-CIT
Experimental: Assess [123I]B-CIT SPECT imaging
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.
Intervention: Drug: [123I]B-CIT SPECT imaging
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
142
May 2007
May 2007   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
22 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT00134784
Elldopa
No
Not Provided
Not Provided
Kenneth Marek, MD, Institute for Neurodegenerative Disorders
Institute for Neurodegenerative Disorders
United States Department of Defense
Principal Investigator: Kenneth L Marek, MD Institute for Neurodegenerative Disorders
Institute for Neurodegenerative Disorders
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP