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
Full record on ClinicalTrials.gov