A Study to Evaluate the Diagnostic Efficacy of DaTSCAN™ Ioflupane (123I) Injection in Single Photon Emission Computed Tomography (SPECT) for the Diagnosis of Parkinsonian Syndrome (PS) in Chinese Patients

Inclusion criteria

For all participants:

• Chinese male or female, aged 40 to 80 years, has agreed to sign and date the written informed consent form.

For Healthy Volunteers:

• Non-patient volunteers with good age-appropriate health as established by clinical examination during screening and no evidence of movement disorder by complete neurological evaluation.

For participants with Parkinson's disease:

• A diagnosis of clinically established or clinically probable PD in accordance with the Movement Disorder Society (MDS) Clinical Diagnostic Criteria for Parkinson's Disease.

For participants with MSA (SDD):

• A diagnosis of probable or possible MSA in accordance with the Second Consensus Statement on the Diagnosis of MSA.

For participants with PSP (SDD):

• A diagnosis of probable or possible PSP in accordance with the Clinical Criteria for the Diagnosis of Progressive Supranuclear Palsy National Institute for Neurological Disorders and Society for PSP (NINDS-SPSP)

For participants with ET (no SDD):

• A diagnosis of definite or probable ET in accordance with the Washington Heights-Inwood Genetic Study of Essential Tremor (WHIGET) diagnostic criteria for ET (no SDD) .

Exclusion criteria

• The participant is lactating.
• The participant is pregnant as detected by a β-human chorionic gonadotropin (β-hCG) pregnancy test.
• A cerebral structural vascular abnormality indicative of at least 1 infarction in the region of the basal ganglia (including the internal capsule) ≥5 mm has been confirmed, preferably by magnetic resonance imaging (MRI) performed within 6 months of screening. If an MRI is not clinically feasible, cerebral CT imaging within 6 months is also acceptable.
• The participant is diagnosed with major neurocognitive disorder by the Diagnostic and Statistical Manual of Mental Disorders (DSM) 5 criteria, or Mini-Mental State Examination total score is <24.
• Participant is being investigated for or has been diagnosed and/or is being treated for repeated stroke with stepwise progression of Parkinson features.
• History of repeated head injury (≥3 concussions, or history of professional sports with repeated head trauma [e.g., boxing]).
• History of definite encephalitis (≥1 episode of confirmed encephalitis with objective residual neurologic deficit).
• The participant is using or has insufficient washout from medication known or suspected to interact with striatal uptake through direct competition with binding of DaTSCAN™ to the dopamine transporters (i.e., amphetamine, benztropine, bupropion, cocaine, mazindol, methylphenidate, phentermine, sertraline, selective serotonin reuptake inhibitors) before the imaging visit.
• The participant is using Chinese traditional medicine for PD treatment, which cannot be safely withdrawn for at least 1 week (7 days) before the imaging visit.
• The participant has a moderate to severe renal impairment (e.g., serum creatinine >1.5x upper limit of normal [ULN], blood urea nitrogen [BUN] >30 mg/dL).
• The participant has a moderate to severe hepatic impairment (bilirubin >2x ULN and alanine aminotransferase (ALT) or aspartate aminotransferase (AST)>3x ULN).
• The participant has a history of current abuse of drugs and/or alcohol (for the previous 12 months before trial enrolment).
• The participant has a history of occupational exposure to any radiation >50 millisievert/year (mSv/year).
• The participant has been previously enrolled in this study or participated in a clinical study involving an investigational pharmaceutical product within 30 days prior to screening and/or any radiopharmaceutical within a minimum of 5 radioactive half-lives prior to screening.
• The participant presents with symptoms suggestive of corticobasal degeneration or Huntington's disease.
• The participant has known allergies to the investigational medicinal product (IMP).
• The participant presents with any clinically active, serious, life-threatening disease with a life expectancy of less than 12 months.
• Any laboratory value(s) exceeding the limits of normality if deemed to be clinically relevant by the investigator.
• The participant complains of claustrophobia.
• The participant has a moderate to severe thyroid disease (thyroid stimulating hormone [TSH] exceeding the limits of normality by more than 10%), if deemed to be clinically relevant by the investigator.

For participants with ET:

• The participant has at least 1 first-degree relative diagnosed with PD.

For Healthy Volunteers:

• History of psychiatric illness.

For all participants:

• It is the physician's best judgment not to include the participant in the trial.