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.

Condition	Intervention	Phase
Parkinson''''s Disease Parkinsonian Syndrome	Procedure: [123I]ß-CIT and SPECT imaging	Phase II

Further Study Details: 

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.
Expected Total Enrollment:  500

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.

Ages Eligible for Study:  35 Years and above,  Genders Eligible for Study:  Both

Criteria

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

Study chairs or principal investigators

Kenneth Marek, MD,  Principal Investigator,  Institute for Neurodegenerative Disorders   

Study ID Numbers:  Dopamine Transporter Imaging
Last Updated:  August 19, 2005
Record first received:  August 18, 2005
ClinicalTrials.gov Identifier:  NCT00132626
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-08-23