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Completed

NCT Number: NCT00132626

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

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.

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Key information

Conditions

Parkinson's Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Disease Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinson Disease Parkinsonian Disorders Parkinsonian Syndrome Pathologic Processes Pathological Conditions, Signs and Symptoms Synucleinopathies

Age range

35 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

[123I]ß-CIT and SPECT imaging

Drug

Primary outcomes

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

Secondary outcomes

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

Sponsors and collaborators

Lead sponsor

Institute for Neurodegenerative Disorders

Other

Collaborators

  • Molecular NeuroImaging
  • National Institutes of Health (NIH)

Registry information

Official study title

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

Important dates

Study start
1992
Study completion
2005
First posted
Aug 22, 2005
Registry last updated
Apr 3, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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