Validation of DaTscan for Detection of Parkinson Disease Related Disorders

July 15, 2014 updated by: Paul Nausieda, Wisconsin Institute for Neurologic and Sleep Disorders S.C.

Validation of DaTscan for Detection of Parkinsonian Disease and Related Disorders Using Neuropathologically-confirmed Parkinson Disease From Human Brain Tissue

This investigator initiated trial is designed to measure the accuracy of diagnosis of Parkinson disease through the use of DaTscan. Currently, DaTscan is FDA approved to measure dopamine transporter densities in human tissue. This measurement can assist in distinguishing between Essential Tremor and Parkinsonian Syndromes (idiopathic Parkinson disease, Progressive Supranuclear Palsy, Multi Systems Atrophy, etc). This study will compare both clinical diagnosis of symptoms and the results of the scan to the pathological diagnosis received at time of death. Patients will be registered in the Parkinson Research Institute's brain donation program, receive a clinical diagnosis of Parkinson disease, have their brain scanned using DaTscan, and donate their tissue for research and autopsy purposes. The hypothesis of the study is that DaTscan will diagnosis Idiopathic Parkinson Disease as accurately as a clinician.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Medical College of Wisconsin
      • Milwaukee, Wisconsin, United States, 53233
        • Wisconsin Institute for Neurologic and Sleep Disorders, SC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

75 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Parkinson disease patients from Wisconsin Institute for Neurologic and Sleep Disorders, SC.

Description

Inclusion Criteria:

  • aged 75 or older
  • sporadic late onset Parkinson disease or one of its variants
  • registered in tissue donation program

Exclusion Criteria:

  • aged less than 75 years old
  • mental status preventing neuroimaging or transportation to site
  • inability to remain "relatively steady" during the scanning procedure

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
l-123 Ioflupane
Study group includes those clinically diagnosed with Parkinson disease who are aged 75 and older who have agreed to donate brain tissue at time of death and are able to participate in the imaging scan process.
Drug: l-123 Ioflupane
5 millicuries of Ioflupane
Other Names:
  • DaTscan

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Consistency Between Diagnostic Procedures
Time Frame: Will be assessed upon receipt of autopsy report- time frame per patient is 24 months from enrollment.
Consistency of diagnosis between: (1) clinical diagnosis, (2) scan results, and (3) pathological results.
Will be assessed upon receipt of autopsy report- time frame per patient is 24 months from enrollment.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wisconsin Institute for Neurologic and Sleep Disorders S.C.

Collaborators

GE Healthcare
Medical College of Wisconsin
Wisconsin Parkinson Association

Investigators

  • Principal Investigator: Paul A Nausieda, MD, Wisconsin Institute for Neurologic and Sleep Disorders

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2014

Primary Completion (Anticipated)

April 1, 2016

Study Registration Dates

First Submitted

April 24, 2014

First Submitted That Met QC Criteria

May 12, 2014

First Posted (Estimate)

May 14, 2014

Study Record Updates

Last Update Posted (Estimate)

July 16, 2014

Last Update Submitted That Met QC Criteria

July 15, 2014

Last Verified

July 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12-DAT-014

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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