CompletedEarly Phase 1

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

United States12 participantsStarted 2020-12-24

Plain-language summary

The overall goal of this protocol is to evaluate \[18F\]MNI-1216 (also known as \[18F\]ACI-12589) as an α-synuclein targeted radiopharmaceutical in 3 parts as follows: * Part 1: first in human (FiH) imaging * Optional Part 2: expansion of FiH imaging * Optional Part 3: retest imaging A total of up to 30 participants may be enrolled and participate in the study. Part 1 of the study will include up to 10 participants (target of up to 5 healthy volunteers and up to 5 participants with idiopathic Parkinson's Disease). There will be an ongoing review of study data in Part 1 to evaluate the characteristics of tracer binding and safety. If the study results are deemed adequate in Part 1, Part 2 and/or Part 3 may be initiated. The decision to initiate Part 3 may also include a review of data from Part 2, if Part 2 is performed and the data are available. If performed, Part 2 will include up to 20 participants, including health volunteers and participants with α-synucleinopathies to acquire additional tracer-related data. If performed, Part 3 will include up to 10 participants from in Part 1 and/or Part 2 (including health volunteers and participants with α-synucleinopathies) to evaluate the reliability of \[18F\]MNI-1216 (\[18F\]ACI-12589) Positron Emission Tomography (PET) imaging.

Who can participate

Age range21 Years

SexALL

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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 s…

What they're measuring

Volume of distribution (VT) of [18F]MNI-1216 across multiple brain regions

Timeframe: up to 78 days

Number of participants with [18F]MNI-1216-related adverse events as assessed by CTCAE

Timeframe: up to 78 days

Trial details

NCT IDNCT06445465

SponsorInvicro

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-11-26