Study to Evaluate a Potential PET Radioligand for Imaging Alpha-synuclein Deposits in the Brain

Inclusion Criteria

• •Participants is able to provide written informed consent, which must be obtained before any assessment is performed.
• •Female participants must not be of childbearing potential, or agree to use contraception and not donate eggs if of childbearing potential. At the discretion of the Investigator, participants without documentation of non-childbearing potential may receive pregnancy testing.
• •* A woman is considered to be of childbearing potential if postmenarchal, has not reached a postmenopausal state (12 continuous months of amenorrhea with no identified cause other than menopause), and is not permanently infertile due to surgery (ie, removal of ovaries, fallopian tubes, and/or uterus) or another cause as determined by the PI (eg, Müllerian agenesis).
• •* Women of childbearing potential must commit to remain abstinent (refrain from heterosexual intercourse) or use 2 forms of birth control, 1 of which is a barrier contraception method, for the duration of the study and 30 days after study completion. Periodic abstinence (eg, calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not adequate methods of contraception.
• •* Women of childbearing potential must commit to not donate ovum for the duration of the study and 30 days after study completion.
• •Male participants and their partners of childbearing potential must commit to the use of 2 methods of contraception, 1 of which is a barrier method for male participants for the study duration and 90 days after study completion.
• •Male participants must not donate sperm for the study duration and for 90 days after study completion.
• •Willing and able to cooperate with study procedures.
• •For participants receiving arterial cannulation, adequate circulation to the hand for safe placement of arterial line (as determined by Allen's test) and blood clotting (PT and PTT).
• •If participant takes bupropion, participant must agree to hold this medication for at least 12 hours prior to DaTscan imaging (if performed).
• •Males and females aged ≥ 21 years.
• •Healthy with no clinically relevant finding on physical examination at Screening and upon reporting to the clinic for the \[18F\]MNI-1216 (\[18F\]ACI-12589) Imaging Visit.
• •No family history of α-synucleinopathy, including PD, or other early-onset neurological disease associated with dementia.
• •No personal history of clinically significant neurologic and/or psychiatric disorders.
• •No evidence of dopamine transporter deficit on DaTscan performed either as part of Screening or on previously acquired DaTscan (within 6 months prior to signing consent).
• •Have a Montreal Cognitive Assessment (MoCA) score ≥ 26.
• •No cognitive impairment as judged by the PI.
• •Males and females aged ≥ 40 years.
• •Participants diagnosed with any of the following:
• •* Idiopathic Parkinson's Disease
• •* Parkinson's Disease with genetic risk factor (except leucine-rich repeat kinase 2 \[LRRK2\] mutation)
• •* Dementia with Lewy Bodies
• •* Multisystem Atrophy