Ignite Creation Date:
2024-06-16 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06445465
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-06-06
First Post:
2024-04-23
Brief Title:
Study to Evaluate a Potential PET Radioligand for Imaging Alpha-synuclein Deposits in the Brain
Sponsor:
Invicro
Organization:
Invicro
Study Overview
Official Title:
Phase 1 Study to Evaluate 18FMNI-1216 18FACI-12589 as a Potential PET Radioligand for Imaging Alpha-synuclein Deposits in the Brain of Patients With Suspected Alpha-synuclein Pathology Compared With Healthy Volunteers
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The overall goal of this protocol is to evaluate 18FMNI-1216 also known as 18FACI-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 Parkinsons 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 andor 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 andor Part 2 including health volunteers and participants with α-synucleinopathies to evaluate the reliability of 18FMNI-1216 18FACI-12589 Positron Emission Tomography PET imaging
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 Parkinsons 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 andor 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 andor Part 2 including health volunteers and participants with α-synucleinopathies to evaluate the reliability of 18FMNI-1216 18FACI-12589 Positron Emission Tomography PET imaging
Detailed Description:
The overall goal of this protocol is to evaluate 18FMNI-1216 also known as 18FACI-12589 as an α-synuclein targeted radiopharmaceutical in 3 parts
The specific objective for Parts 1 2 and 3 is
To characterize 18FMNI-1216 18FACI-12589 as a PET radioligand for imaging α-synuclein pathology
The additional specific objectives for Part 1 and Part 2 are
To visually and quantitatively assess brain uptake and pharmacokinetics of 18FMNI-1216 18FACI-12589 as a PET imaging marker for α-synuclein pathology in individuals with α-synucleinopathies including idiopathic PD compared with corresponding data from healthy volunteer participants
To evaluate the safety of a single injection of 18FMNI-1216 18FACI-12589
The additional specific objectives for Part 3 are
To evaluate the reliability testretest of 18FMNI-1216 18FACI-12589 parameters in individuals with α-synucleinopathies and healthy volunteers
To evaluate the safety of up to 2 injections of 18FMNI-1216 18FACI-12589
For each subject participating in the study the duration of study participation will be up to 78 days
In Part 1 and Part 2 if Part 2 is performed screening assessments will occur within 30 days prior to the Baseline 18FMNI-1216 18FACI-12589 Imaging Visit Day 1 If determined to be necessary by the study team subjects may participate in an 18FFlorbetapir Imaging Visit up to 6 weeks following Day 1 will be completed between Day 2 and Day 42 A Safety Phone Call for adverse event assessment will occur 4 days 2 days following each imaging visit performed In Part 3 if performed subjects will participate in a Retest 18FMNI-1216 18FACI-12589 Imaging Visit between Day 4 and Day 29 within 3 days to 4 weeks following the Baseline 18FMNI-1216 18FACI-12589 Imaging Visit Day 1 A Safety Phone Call for adverse event assessment will occur 4 days 2 days following the retest imaging visit if performed
The specific objective for Parts 1 2 and 3 is
To characterize 18FMNI-1216 18FACI-12589 as a PET radioligand for imaging α-synuclein pathology
The additional specific objectives for Part 1 and Part 2 are
To visually and quantitatively assess brain uptake and pharmacokinetics of 18FMNI-1216 18FACI-12589 as a PET imaging marker for α-synuclein pathology in individuals with α-synucleinopathies including idiopathic PD compared with corresponding data from healthy volunteer participants
To evaluate the safety of a single injection of 18FMNI-1216 18FACI-12589
The additional specific objectives for Part 3 are
To evaluate the reliability testretest of 18FMNI-1216 18FACI-12589 parameters in individuals with α-synucleinopathies and healthy volunteers
To evaluate the safety of up to 2 injections of 18FMNI-1216 18FACI-12589
For each subject participating in the study the duration of study participation will be up to 78 days
In Part 1 and Part 2 if Part 2 is performed screening assessments will occur within 30 days prior to the Baseline 18FMNI-1216 18FACI-12589 Imaging Visit Day 1 If determined to be necessary by the study team subjects may participate in an 18FFlorbetapir Imaging Visit up to 6 weeks following Day 1 will be completed between Day 2 and Day 42 A Safety Phone Call for adverse event assessment will occur 4 days 2 days following each imaging visit performed In Part 3 if performed subjects will participate in a Retest 18FMNI-1216 18FACI-12589 Imaging Visit between Day 4 and Day 29 within 3 days to 4 weeks following the Baseline 18FMNI-1216 18FACI-12589 Imaging Visit Day 1 A Safety Phone Call for adverse event assessment will occur 4 days 2 days following the retest imaging visit if performed
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None