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

Phase 2

Completed

• Conditions: Parkinson Disease
• Interventions: Drug: [123I]B-CIT SPECT imaging

• Registration Number: NCT00134784
• Lead Sponsor: Institute for Neurodegenerative Disorders

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.

Study Timeline

• Study Start: 2000-04
• Study First Submitted: 2005-08-23
• Study First Submitted QC: 2005-08-23
• Study First Posted: 2005-08-25
• Primary Completion: 2007-05
• Study Completion: 2007-05
• Results First Submitted: 2010-10-07
• Status Verified: 2014-07
• Results First Submitted QC: 2014-07-15
• Last Update Submitted: 2014-07-15
• Results First Posted: 2014-08-08
• Last Update Posted: 2014-08-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 142

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Assess [123I]B-CIT SPECT imaging	[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.

Primary Outcome Measures

Name	Time	Method
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.