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

Institute for Neurodegenerative Disorders

Status and phase: Completed; Phase 2

Conditions: Parkinsonian Syndrome; Parkinson's Disease

Treatments: Drug: [123I]ß-CIT and SPECT imaging

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00132626

Dopamine Transporter Imaging

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 35+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)