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

Parkinson's Disease Clinical Trial

Official title:

Dynamic SPECT Imaging With [123I]ß-CIT in Patients With Parkinsonism

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00132626
• Other study ID #: Dopamine Transporter Imaging
• Status: Completed
• Phase: Phase 2
• Start date: September 1992
• Est. completion date: August 2005

Study information

• Verified date: April 2019
• Source: Institute for Neurodegenerative Disorders
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: August 2005
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease
• Parkinsonian Syndrome
• Syndrome

Intervention

Drug:
• [123I]ß-CIT and SPECT imaging

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Institute for Neurodegenerative Disorders	Molecular NeuroImaging, National Institutes of Health (NIH)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CIT uptake: measurement of dopamine transporter density compared with the clinical severity of illness
Secondary	Measurement of variability of strital uptake of [123I]ß-CIT when more than one scan has occurred