Validation of DaTscan for Detection of Parkinson Disease Related Disorders

NCT ID: NCT02138682

Last Updated: 2014-07-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Parkinson Disease Movement Disorders

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

l-123 Ioflupane

Intervention Type DRUG

5 millicuries of Ioflupane

Interventions

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l-123 Ioflupane

5 millicuries of Ioflupane

Intervention Type DRUG

Other Intervention Names

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DaTscan

Eligibility Criteria

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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
Minimum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Wisconsin Parkinson Association

UNKNOWN

Sponsor Role collaborator

Medical College of Wisconsin

OTHER

Sponsor Role collaborator

GE Healthcare

INDUSTRY

Sponsor Role collaborator

Wisconsin Institute for Neurologic and Sleep Disorders S.C.

INDUSTRY

Sponsor Role lead

Responsible Party

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Paul Nausieda

Medical Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Paul A Nausieda, MD

Role: PRINCIPAL_INVESTIGATOR

Wisconsin Institute for Neurologic and Sleep Disorders

Locations

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Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Site Status

Wisconsin Institute for Neurologic and Sleep Disorders, SC

Milwaukee, Wisconsin, United States

Site Status

Countries

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United States

Other Identifiers

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12-DAT-014

Identifier Type: -

Identifier Source: org_study_id

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