Validation of DaTscan for Detection of Parkinsonian Disease and Related Disorders Using Neuropathologically-confirmed Parkinson Disease From Human Brain Tissue
Overview
- Phase
- Not Applicable
- Intervention
- l-123 Ioflupane
- Conditions
- Parkinson Disease
- Sponsor
- Wisconsin Institute for Neurologic and Sleep Disorders S.C.
- Enrollment
- 20
- Locations
- 2
- Primary Endpoint
- Consistency Between Diagnostic Procedures
- Last Updated
- 11 years ago
Overview
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.
Investigators
Paul Nausieda
Medical Director
Wisconsin Institute for Neurologic and Sleep Disorders S.C.
Eligibility 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
Arms & Interventions
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.
Intervention: l-123 Ioflupane
Outcomes
Primary Outcomes
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.