[18F]ACI-15916 PET in α-synucleinopathies
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age20+
SponsorAC Immune SA
About this trial
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 with a licensed tracer (\[18F\]FE-PE2I) to confirm or not the disease\]. * Visit the clinic to receive the tracer \[18F\]ACI-15916 intravenously and be scanned in a PET scanner, during which blood will be collected (and optionally spinal fluid). * Receive a phone call from the clinic 1 week after the PET scan to report any symptoms and side-effects that they may be having.
Some of the participants may be asked to come again to the clinic for a second PET scan with \[18F\]ACI-15916, allowing the researchers to determine if the measurements with the first PET scan are stable and reproducible.
Some of the participants will participate in a specific part of the study to evaluate the distribution of the PET ligand in the whole body, with a similar visit schedule.
Eligibility criteria
Qualifiers
Subject is able to provide written informed consent, which must be obtained before any assessment is performed.
Subjects must be able to understand and be willing to comply with study procedures, restrictions, and requirements.
Body mass index is > 18 and < 31 kg/m2 and Bodyweight ≥ 50 kg and ≤ 100 kg.
Female participants must not be of childbearing potential or agree to use highly effective methods of contraception.
Disqualifiers
Dementia with Lewy bodies (DLB)
Diagnosis of possible or probable Multiple System Atrophy (MSA)
Evidence of dopamine transporter deficit on DAT PET or SPECT imaging performed either as part of Screening or previously acquired (if not older than 6 months) and of good quality as judged by the investigator.
Medications taken for symptomatic treatment of α-synucleinopathy must be maintained on a stable dosage regimen for at least 30 days before the Screening Visit.
Trial design
Treatments tested in this trial
- [18F]ACI-15916
Treatment groups
46 Participants
are divided into 2 treatment groupsSponsors and collaborators
AC Immune SA
Lead sponsor
Karolinska Institutet
Collaborator
Source ClinicalTrials.gov