Early phase 1Recruiting
[18F]ACI-15916 PET in α-synucleinopathies
Phase 1 Study to Evaluate [18F]ACI-15916 as a Potential PET Radioligand for Imaging α-synuclein Deposits in the Brain of Patients With Suspected α-synuclein Pathology Compared With Healthy Volunteers
- Sponsor
- AC Immune SA (Industry)
- Enrolment
- 46 planned
- Conditions
- Parkinson's Disease (PD); Multiple System Atrophy (MSA); Dementia With Lewy Bodies (DLB)
- Interventions
- [18F]ACI-15916
- Ages
- adults, older adults
- Registry
- NCT06891703
From the registry
The goal of this clinical trial is to test whether we can reliably and safely measure the accumulation of pathological protein α-synuclein \[involved in some diseases such as Parkinson's disease, Lewy body dementia and Multiple System Atrophy (MSA), collectively named α-synucleinopathies\] using a new positron emission tomography (PET) tracer called \[18F\]ACI-15916. Both healthy people and people with (suspected) α-synuclein pathology will participate to this trial. The main questions it aims to answer are: * whether \[18F\]ACI-15916 is safe and well tolerated when injected into participants * whether \[18F\]ACI-15916 reliably detects α-synuclein in the brain using PET technique. * whether there are differences in the amount of this protein between people with diseases related to α-synuclein accumulation in the brain and people without these diseases. Participants will: * Visit the clinic to consent to their participation and to ensure they are eligible \[physical and neurological examinations, questionnaires, blood and urine tests, ECG and in some cases a MRI and a PET scan…
Primary outcomes
- Number of participants with Adverse Events (AEs) assessed by severity (mild, moderate, severe, life threatening, death) and causal relationship (not related, unlikely related, possibly related or related)
- Number of participants with clinically significant changes in vital signs measurements
- Brain uptake of the tracer [18F]ACI-15916