An open label, multicenter study, evaluating the safety and efficacy of 18F-AV-133 PET imaging to identify subjects with dopaminergic degeneration among subjects presenting to a movement disorders specialty clinic with an uncertain diagnosis

Study ID
STU 012013-001

Cancer Related
No

Healthy Volunteers
No

Study Sites

  • UT Southwestern Ambulatory Services
  • UT Southwestern University Hospital—St. Paul

Contact
Jennifer Hawkins
817/307-4408
jennifer.hawkins@utsouthwestern.edu

Principal Investigator
Padraig O'Suilleabhain

Summary

an open label, multicenter study, evaluating the safety and efficacy of 18F-aV-133
PeT imaging to identify subjects with dopaminergic degeneration among subjects
presenting to a movement disorders specialty clinic with an uncertain diagnosis.

Participant Eligibility

Subjects who meet all of the following criteria are eligible to enroll in this trial:
1. Males or females >= 40 years of age;
2.
* Presenting recently (if not within the last 3 months, the Sponsor should be contacted prior to enrolling the subject) for an initial evaluation to a movement disorders specialist with signs or symptoms suggestive of a movement disorder
*
3. The subject[Single Quote]s signs or symptoms were previously evaluated by a physician who was not
a movement disorders specialist during the previous six months;
4. Absence of an established clinical movement disorder diagnosis;
5. Symptoms mild in intensity, this includes Hoehn & Yahr <= 2*;
6. Montreal Cognitive Assessment (MoCA) score >= 22;
7. Can tolerate imaging visit procedures
8. Provide written informed consent prior to study entry.
*Exceptions are allowed for subjects who meet criteria for Hoehn & Yahr stage 3 due to early onset of postural instability and/or gait impairment out of proportion to his/her other Parkinson signs and symptoms