NCT00132626

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Sep 1992

Longer than P75 for phase_2

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 1992

Completed
12.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2005

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

August 18, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 22, 2005

Completed
Last Updated

April 3, 2019

Status Verified

April 1, 2019

First QC Date

August 18, 2005

Last Update Submit

April 1, 2019

Conditions

Parkinson's DiseaseParkinsonian Syndrome

Keywords

parkinsondiagnosis

Outcome Measures

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

Interventions

[123I]ß-CIT and SPECT imagingDRUG

Eligibility Criteria

Age35 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Pregnancy
  • Significant medical disease including abnormalities found on screening

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Parkinson DiseaseParkinsonian DisordersDisease

Condition Hierarchy (Ancestors)

Basal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Kenneth Marek, MD

    Institute for Neurodegenerative Disorders

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 18, 2005

First Posted

August 22, 2005

Study Start

September 1, 1992

Study Completion

August 1, 2005

Last Updated

April 3, 2019

Record last verified: 2019-04