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A Trial of 18F-AV-133 Positron Emission Tomography (PET) Imaging to Differentiate Subjects With Parkinson's Disease (PD) From Other Movement Disorders

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01550484
Recruitment Status : Completed
First Posted : March 12, 2012
Last Update Posted : February 10, 2017
Information provided by (Responsible Party):
Avid Radiopharmaceuticals

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.

Condition or disease Intervention/treatment Phase
Parkinson's Disease Primary Parkinsonism Lewy Body Parkinson's Disease Drug: 18F-AV-133 Phase 2 Phase 3

Detailed Description:
The early detection and monitoring of neurodegenerative diseases including Parkinson's disease (PD), Alzheimer's disease (AD), Dementia with Lewy Bodies (DLB), and other dementias and movement disorders represent a very significant unmet medical need. Disease mechanisms are gradually becoming understood, and disease-modifying drugs are emerging that target the specific molecular pathology underlying each of these diseases. Tools for accurate and early differential diagnosis are thus necessary to determine the appropriate treatment for patients and to minimize inappropriate use of potentially harmful treatments. In addition, such diagnostic imaging tools are expected to permit monitoring of disease progression and will thus accelerate testing and development of disease-modifying drugs. Furthermore, the new imaging test may be useful as a prognostic tool by identifying humans suffering from neurodegenerative diseases before the clinical manifestations become evident.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 170 participants
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: 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 Start Date : April 2012
Actual Primary Completion Date : March 2016
Actual Study Completion Date : March 2016

Resource links provided by the National Library of Medicine

Intervention Details:
  • Drug: 18F-AV-133
    222 MBq (6 mCi)

Primary Outcome Measures :
  1. Sensitivity of visual read of AV-133 PET scan vs. standard of truth [ Time Frame: 18 months ]

    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.

  2. Specificity of visual read of AV-133 PET scan vs. standard of truth [ Time Frame: 18 months ]

    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.

Secondary Outcome Measures :
  1. Inter-rater reliability of the visual read [ Time Frame: 18 months ]
    Fleiss' kappa

  2. Intra-rater reliability of the visual read [ Time Frame: 18 months ]
    Intra-class kappa

  3. Probability of progressive motor skill impairment [ Time Frame: 18 months ]
    Compare rates of progressive impairment using PD rating scale in subjects with positive AV-133 PET scan vs. progressive impairment in subjects with negative AV-133 PET scan

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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 clinically meaningful cognitive impairment or dementia (mild cognitive problems as might be expected in the earliest stages of PD are not exclusionary);
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01550484

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United States, Arizona
Research Site
Scottsdale, Arizona, United States, 85259
Research Site
Sun City, Arizona, United States, 85351
United States, Connecticut
Research Site
New Haven, Connecticut, United States, 06510
United States, Kansas
Research Site
Kansas City, Kansas, United States, 66160
United States, Louisiana
Research Site
Shreveport, Louisiana, United States, 71103
United States, Maryland
Research Site
Baltimore, Maryland, United States, 21287
United States, Massachusetts
Research Site
Boston, Massachusetts, United States, 02114
United States, Missouri
Research Site
St. Louis, Missouri, United States, 63110
United States, Nevada
Research Site
Las Vegas, Nevada, United States, 89106
United States, Ohio
Research Site
Cleveland, Ohio, United States, 44195
United States, Pennsylvania
Research Site
Philadelphia, Pennsylvania, United States, 19107
United States, Rhode Island
Research Site
Providence, Rhode Island, United States, 02906
United States, Texas
Research Site
Dallas, Texas, United States, 75390
Research Site
Houston, Texas, United States, 77030
Australia, New South Wales
Research Site
Sydney, New South Wales, Australia, 2109
Sponsors and Collaborators
Avid Radiopharmaceuticals
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Study Director: Chief Medical Officer Avid Radiopharmaceuticals

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Responsible Party: Avid Radiopharmaceuticals Identifier: NCT01550484    
Other Study ID Numbers: 18F-AV-133-B04
First Posted: March 12, 2012    Key Record Dates
Last Update Posted: February 10, 2017
Last Verified: February 2017
Additional relevant MeSH terms:
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Parkinson Disease
Movement Disorders
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases