Validation of DaTscan for Detection of Parkinson Disease Related Disorders

NCT02138682 | Unknown

• 1 other identifier: 12-DAT-014
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 2

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.

Conditions

Parkinson Disease; Movement Disorders

Keywords

DaT-SPECT scan; Parkinson's; Diagnostic

Outcome Measures

Primary Outcomes (1)

• Consistency Between Diagnostic Procedures

  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.

Study Arms (1)

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

Interventions

l-123 Ioflupane DRUG

5 millicuries of Ioflupane

Also known as: DaTscan

l-123 Ioflupane

Eligibility Criteria

• Age: 75 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Wisconsin Institute for Neurologic and Sleep Disorders S.C.: lead
• Wisconsin Parkinson Association: collaborator
• Medical College of Wisconsin: collaborator
• GE Healthcare: collaborator

Study Sites (2)

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Wisconsin Institute for Neurologic and Sleep Disorders, SC

Milwaukee, Wisconsin, 53233, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Fixed brain tissue

MeSH Terms

Conditions

Parkinson Disease; Movement Disorders; Disease

Interventions

ioflupane

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Synucleinopathies; Neurodegenerative Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Paul A Nausieda, MD

  Wisconsin Institute for Neurologic and Sleep Disorders

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Director

Study Record Dates

• First Submitted: April 24, 2014
• First Posted: May 14, 2014
• Study Start: July 1, 2014
• Primary Completion: April 1, 2016
• Last Updated: July 16, 2014

Record last verified: 2014-07

Locations

US (2)