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

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT01550484
• Date of registration: 06/03/2012
• Prospective Registration: Yes
• Primary sponsor: Avid Radiopharmaceuticals
• Public title: A Trial of 18F-AV-133 Positron Emission Tomography (PET) Imaging to Differentiate Subjects With Parkinson's Disease (PD) From Other Movement Disorders
• Scientific 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
• Date of first enrolment: April 2012
• Target sample size: 170
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01550484
• Study type: Interventional
• Study design: Intervention model: Single Group Assignment. Primary purpose: Diagnostic. Masking: Single (Outcomes Assessor).
• Phase: Phase 2/Phase 3

Countries of recruitment

Australia, United States

Contacts

• Name: Chief Medical Officer
• Affiliation: Avid Radiopharmaceuticals

Key inclusion & exclusion 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.



Age minimum: 40 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Lewy Body Parkinson's Disease

Parkinson's Disease

Primary Parkinsonism

Intervention(s)

Drug: 18F-AV-133

Primary Outcome(s)

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

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

Secondary Outcome(s)

Inter-rater reliability of the visual read [Time Frame: 18 months]

Probability of progressive motor skill impairment [Time Frame: 18 months]

Intra-rater reliability of the visual read [Time Frame: 18 months]

Secondary ID(s)

18F-AV-133-B04

Source(s) of Monetary Support

Please refer to primary and secondary sponsors