Study of Brain Imaging With Nuclear Technology in Individuals With Parkinsonian Syndrome

Institute for Neurodegenerative Disorders500 enrolled

Overview

This study assesses dopamine transporter density using single photon emission computed tomography (SPECT) brain imaging with an investigational radiopharmaceutical, \[123I\]ß-CIT, in research participants with Parkinson's disease.

The brain imaging is conducted at the Institute for Neurodegenerative Disorders in New Haven, Connecticut. The imaging procedure occurs over a two day period. After a screening visit, including review of the potential subject's neurological history and a thorough neurologic exam, subjects are injected with \[123I\]ß CIT, an investigational radioactive material that localizes in the brain. Twenty-four hours later study participants return to the Institute for Neurodegenerative Disorders where an investigational scanning procedure is used to obtain SPECT (single photon emission computed tomography) images of the brain.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

500

Conditions

Parkinson's Disease Parkinsonian Syndrome

Interventions

[123I]ß-CIT and SPECT imagingDRUG

Eligibility

Sex: ALLMin age: 35 Years

Medical Language ↔ Plain English

Inclusion Criteria: * At least 21 years of age * Normal screening laboratory studies * At least two of the following: resting tremor, cogwheel rigidity, bradykinesia, and postural reflex impairment Exclusion Criteria: * Pregnancy * Significant medical disease including abnormalities found on screening

Outcomes

Primary Outcomes

CIT uptake: measurement of dopamine transporter density compared with the clinical severity of illness

Secondary Outcomes

Measurement of variability of strital uptake of [123I]ß-CIT when more than one scan has occurred

Data from ClinicalTrials.gov

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