A Trial of 18F-AV-133 Positron Emission Tomography (PET) Imaging to Differentiate Subjects With Parkinson's Disease (PD) From Other Movement Disorders
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
1 other identifier
interventional
170
2 countries
15
Brief Summary
The purpose of this study is to determine whether 18F-AV-133 PET scans can be used to differentiate subjects with Parkinson's Disease from other movement disorders.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Apr 2012
Typical duration for phase_2
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 6, 2012
CompletedFirst Posted
Study publicly available on registry
March 12, 2012
CompletedStudy Start
First participant enrolled
April 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2016
CompletedFebruary 9, 2017
February 1, 2017
3.9 years
March 6, 2012
February 8, 2017
Conditions
Outcome Measures
Primary Outcomes (2)
Sensitivity of visual read of AV-133 PET scan vs. standard of truth
Sensitivity will be calculated as the percent of true positives which are correctly identified An expert, consensus diagnosis of PD performed by a panel of movement disorders specialists will be used as the standard of truth.
18 months
Specificity of visual read of AV-133 PET scan vs. standard of truth
Specificity will be calculated as the percent of true negatives which are correctly identified. An expert, consensus diagnosis of PD performed by a panel of movement disorders specialists will be used as the standard of truth.
18 months
Secondary Outcomes (3)
Inter-rater reliability of the visual read
18 months
Intra-rater reliability of the visual read
18 months
Probability of progressive motor skill impairment
18 months
Interventions
222 MBq (6 mCi)
Eligibility Criteria
You may qualify if:
- Males or females ≥ 40 years of age;
- Presenting (within the last 3 months) for an initial evaluation to a movement disorders specialist with signs or symptoms suggestive of a movement disorder;
- The subject's signs or symptoms were previously evaluated by a physician who was not a movement disorders specialist during the previous six months;
- Absence of an established clinical movement disorder diagnosis;
- Symptoms mild in intensity, this includes Hoehn \& Yahr ≤ 2 (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);
- Montreal Cognitive Assessment (MoCA) score ≥ 22;
- Can tolerate imaging visit procedures; and
- Provide written informed consent prior to study entry.
You may not qualify if:
- Have been referred to the movement disorders clinic primarily for the purpose of disease management (no diagnostic uncertainty exists on the part of the non-specialist or referring physician);
- Have a previous movement disorder diagnosis given by a movement disorders specialist prior to the time of enrollment;
- Have received a total of more than 90 days treatment with dopaminergic medications, including direct dopamine agonists or precursors (levodopa) or have received a total of more than 180 days treatment with MAO-B inhibitors, amantadine, anticholinergics or primidone or beta-blockers prescribed for treatment of tremor or signs of parkinsonism;
- Have had a sustained and clinically meaningful response to anti-parkinsonian medications;
- Are currently taking or have taken MAO-B inhibitors in the past 4 weeks;
- Have a known CNS structural lesion such as stroke or tumor that likely accounts for their symptoms;
- Have current clinically significant cardiovascular disease or clinically important abnormalities on screening ECG (including but not limited to QTc \> 450 msec);
- Are currently taking medications that are known to cause QT-prolongation;
- Are currently taking medications with narrow therapeutic windows (e.g. warfarin or other anticoagulant therapies);
- Are currently taking tetrabenazine (TBZ), amphetamine type drugs;
- Have a current clinically significant endocrine or metabolic disease, pulmonary, renal or hepatic impairment, or cancer (excluding localized basal cell carcinoma and in situ prostate cancer) that would interfere with completion of the study;
- Have a recent history (within the past year) of alcohol or substance abuse or dependence;
- Are females of childbearing potential who are not surgically sterile, not refraining from sexual activity or not using reliable contraception. Females must not be pregnant (negative serum beta-hCG at the time of screening and negative urine beta-hCG on the day of imaging), must not be breastfeeding at screening, must avoid becoming pregnant and use adequate contraceptive methods for 14 days prior to and 24 hours after administration of 18F-AV-133 for injection;
- Have had prior intracranial surgery; and
- Are receiving any investigational medications, or have participated in a trial with investigational medications within the last 30 days.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (15)
Research Site
Scottsdale, Arizona, 85259, United States
Research Site
Sun City, Arizona, 85351, United States
Research Site
New Haven, Connecticut, 06510, United States
Research Site
Kansas City, Kansas, 66160, United States
Research Site
Shreveport, Louisiana, 71103, United States
Research Site
Baltimore, Maryland, 21287, United States
Research Site
Boston, Massachusetts, 02114, United States
Research Site
St Louis, Missouri, 63110, United States
Research Site
Las Vegas, Nevada, 89106, United States
Research Site
Cleveland, Ohio, 44195, United States
Research Site
Philadelphia, Pennsylvania, 19107, United States
Research Site
Providence, Rhode Island, 02906, United States
Research Site
Dallas, Texas, 75390, United States
Research Site
Houston, Texas, 77030, United States
Research Site
Sydney, New South Wales, 2109, Australia
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Chief Medical Officer
Avid Radiopharmaceuticals
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 6, 2012
First Posted
March 12, 2012
Study Start
April 1, 2012
Primary Completion
March 1, 2016
Study Completion
March 1, 2016
Last Updated
February 9, 2017
Record last verified: 2017-02