Validation of DaTscan for Detection of Parkinson Disease Related Disorders

Wisconsin Institute for Neurologic and Sleep Disorders S.C.

Status: Unknown

Conditions: Movement Disorders; Parkinson Disease

Treatments: Drug: l-123 Ioflupane

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT02138682

12-DAT-014

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 75+ years old

Volunteers: No Healthy Volunteers

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

Trial design

20 participants in 1 patient group

l-123 Ioflupane

Description:

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.

Treatment:

Drug: l-123 Ioflupane