Overview

This trial is active, not recruiting.

Condition parkinson's disease
Treatment [123i]ß cit and spect imaging
Phase phase 2
Sponsor Institute for Neurodegenerative Disorders
Collaborator Department of Defense
Start date April 2000
Trial size 150 participants
Trial identifier NCT00134784, Elldopa

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment

Primary Outcomes

Measure
To assess the rate of change in striatal [123I]ß-CIT uptake in a cohort of early Parkinson's disease patients
time frame:

Secondary Outcomes

Measure
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
time frame:
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
time frame:
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
time frame:
To determine cognitive changes in Parkinson's disease and correlate those changes with objective imaging measures of dopaminergic degeneration
time frame:

Eligibility Criteria

Male or female participants at least 22 years old.

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

Additional Information

Official title [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
Principal investigator Kenneth L Marek, MD
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, nine, eighteen and thirty-six months following the start of their participation in the ELLDOPA study. In this extension study the subjects will receive two additional scans, at forty-eight months and at sixty months 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.
Trial information was received from ClinicalTrials.gov and was last updated in January 2008.
Information provided to ClinicalTrials.gov by Institute for Neurodegenerative Disorders.