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Validation of DaTscan for Detection of Parkinson Disease Related Disorders

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02138682
Recruitment Status : Unknown
Verified July 2014 by Paul Nausieda, Wisconsin Institute for Neurologic and Sleep Disorders S.C..
Recruitment status was:  Enrolling by invitation
First Posted : May 14, 2014
Last Update Posted : July 16, 2014
Sponsor:
Collaborators:
Wisconsin Parkinson Association
Medical College of Wisconsin
GE Healthcare
Information provided by (Responsible Party):
Paul Nausieda, Wisconsin Institute for Neurologic and Sleep Disorders S.C.

Brief Summary:
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.

Condition or disease Intervention/treatment
Parkinson Disease Movement Disorders Drug: l-123 Ioflupane

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Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Validation of DaTscan for Detection of Parkinsonian Disease and Related Disorders Using Neuropathologically-confirmed Parkinson Disease From Human Brain Tissue
Study Start Date : July 2014
Estimated Primary Completion Date : April 2016


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 Name: DaTscan




Primary Outcome Measures :
  1. 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.


Biospecimen Retention:   Samples Without DNA
Fixed brain tissue


Information from the National Library of Medicine

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Ages Eligible for Study:   75 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Parkinson disease patients from Wisconsin Institute for Neurologic and Sleep Disorders, SC.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02138682


Locations
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United States, Wisconsin
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Wisconsin Institute for Neurologic and Sleep Disorders, SC
Milwaukee, Wisconsin, United States, 53233
Sponsors and Collaborators
Wisconsin Institute for Neurologic and Sleep Disorders S.C.
Wisconsin Parkinson Association
Medical College of Wisconsin
GE Healthcare
Investigators
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Principal Investigator: Paul A Nausieda, MD Wisconsin Institute for Neurologic and Sleep Disorders
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Responsible Party: Paul Nausieda, Medical Director, Wisconsin Institute for Neurologic and Sleep Disorders S.C.
ClinicalTrials.gov Identifier: NCT02138682    
Other Study ID Numbers: 12-DAT-014
First Posted: May 14, 2014    Key Record Dates
Last Update Posted: July 16, 2014
Last Verified: July 2014
Keywords provided by Paul Nausieda, Wisconsin Institute for Neurologic and Sleep Disorders S.C.:
DaT-SPECT scan
Parkinson's
Diagnostic
Additional relevant MeSH terms:
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Parkinson Disease
Movement Disorders
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases