search
Back to results

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

Primary Purpose

Parkinson's Disease, Parkinsonian Syndrome

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
[123I]ß-CIT and SPECT imaging
Sponsored by
Institute for Neurodegenerative Disorders
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Parkinson's Disease focused on measuring parkinson, diagnosis

Eligibility Criteria

35 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

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

    Full Information

    First Posted
    August 18, 2005
    Last Updated
    April 1, 2019
    Sponsor
    Institute for Neurodegenerative Disorders
    Collaborators
    Molecular NeuroImaging, National Institutes of Health (NIH)
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT00132626
    Brief Title
    Study of Brain Imaging With Nuclear Technology in Individuals With Parkinsonian Syndrome
    Official Title
    Dynamic SPECT Imaging With [123I]ß-CIT in Patients With Parkinsonism
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    September 1992 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    August 2005 (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Institute for Neurodegenerative Disorders
    Collaborators
    Molecular NeuroImaging, National Institutes of Health (NIH)

    4. Oversight

    5. Study Description

    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.
    Detailed 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Parkinson's Disease, Parkinsonian Syndrome
    Keywords
    parkinson, diagnosis

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    500 (false)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    [123I]ß-CIT and SPECT imaging
    Primary Outcome Measure Information:
    Title
    CIT uptake: measurement of dopamine transporter density compared with the clinical severity of illness
    Secondary Outcome Measure Information:
    Title
    Measurement of variability of strital uptake of [123I]ß-CIT when more than one scan has occurred

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    35 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Kenneth Marek, MD
    Organizational Affiliation
    Institute for Neurodegenerative Disorders
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

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

    We'll reach out to this number within 24 hrs