Parkinson's DiseasePhase 2/3NCT01550484
A Trial of 18F-AV-133 Positron Emission Tomography (PET) Imaging to Differentiate Subjects With Parkinson's Disease (PD) From Other Movement Disorders
A Phase 2/3 study testing 18F-AV-133 in people with Parkinson's Disease and Primary Parkinsonism, run by Avid Radiopharmaceuticals at 15 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Parkinson's Disease, Primary Parkinsonism, Lewy Body Parkinson's Disease
- What is being tested?
- 18F-AV-133
- How many people
- 170 participants
- Where
- 15 sitesin 2 countries
- Study dates
- Apr 2012to Mar 2016
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
15 sites in 2 countries.
15 sites in 2 countries
United States14 sites
Research Site
Baltimore, Maryland, 21287
Research Site
Boston, Massachusetts, 02114
Research Site
Cleveland, Ohio, 44195
Research Site
Dallas, Texas, 75390
Research Site
Houston, Texas, 77030
Research Site
Kansas City, Kansas, 66160
Research Site
Las Vegas, Nevada, 89106
Research Site
New Haven, Connecticut, 06510
Research Site
Philadelphia, Pennsylvania, 19107
Research Site
Providence, Rhode Island, 02906
Research Site
Scottsdale, Arizona, 85259
Research Site
Shreveport, Louisiana, 71103
Research Site
St Louis, Missouri, 63110
Research Site
Sun City, Arizona, 85351
About this study
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
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.
Read the 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.
- Being tested
- 18F-AV-133
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
18F-AV-133Drug
222 MBq (6 mCi)
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 18 months
Secondary outcomes (3)
Inter-rater reliability of the visual read
Fleiss' kappa
Measured: 18 months
Intra-rater reliability of the visual read
Intra-class kappa
Measured: 18 months
Probability of progressive motor skill impairment
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
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2012 (estimated)
- Study startApr 2012
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 170 participants (actual)
Sponsor and investigators
- Lead sponsor
- Avid Radiopharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Chief Medical Officer, Study director, Avid Radiopharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01550484
- Sponsor's protocol ID
- 18F-AV-133-B04
- Status last verified
- Feb 2017
- First submitted
- 6 Mar 2012
- Last updated
- 9 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01550484
- Acronym / sponsor ID
- 18F-AV-133-B04
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 170 participants (actual)
- Lead sponsor
- Avid RadiopharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Apr 2012
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 12 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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);
Key exclusion criteria (16 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 18F-AV-133222 MBq (6 mCi) | Drug | – |
Primary outcome
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.
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.
3 secondary outcomes
Inter-rater reliability of the visual read
Time frame: 18 months
Intra-rater reliability of the visual read
Time frame: 18 months
Probability of progressive motor skill impairment
Time frame: 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chief Medical Officer study director
Avid Radiopharmaceuticals
15 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing 18F-AV-133 in people with Parkinson's Disease and Primary Parkinsonism, run by Avid Radiopharmaceuticals at 15 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity of visual read of AV-133 PET scan vs. standard of truth (time frame: 18 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2017.