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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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Avid Radiopharmaceuticals
ClinicalTrials.gov Identifier:
NCT01550484
First received: March 6, 2012
Last updated: August 5, 2014
Last verified: August 2014
  Purpose

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 Intervention Phase
Parkinson's Disease
Primary Parkinsonism
Lewy Body Parkinson's Disease
Drug: 18F-AV-133
Phase 2
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (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

Resource links provided by NLM:


Further study details as provided by Avid Radiopharmaceuticals:

Primary Outcome Measures:
  • Sensitivity of visual read of AV-133 PET scan vs. standard of truth [ Time Frame: 18 months ] [ Designated as safety issue: No ]

    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.


  • Specificity of visual read of AV-133 PET scan vs. standard of truth [ Time Frame: 18 months ] [ Designated as safety issue: No ]

    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:
  • Inter-rater reliability of the visual read [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    Fleiss' kappa

  • Intra-rater reliability of the visual read [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    Intra-class kappa

  • Probability of progressive motor skill impairment [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 150
Study Start Date: April 2012
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: 18F-AV-133
    222 MBq (6 mCi)
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.

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01550484

Locations
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
Investigators
Study Director: Chief Medical Officer Avid Radiopharmaceuticals
  More Information

No publications provided

Responsible Party: Avid Radiopharmaceuticals
ClinicalTrials.gov Identifier: NCT01550484     History of Changes
Other Study ID Numbers: 18F-AV-133-B04
Study First Received: March 6, 2012
Last Updated: August 5, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Movement Disorders
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases

ClinicalTrials.gov processed this record on November 20, 2014