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