[18F]ACI-15916 PET in α-synucleinopathies (NCT06891703) | Clinical Trial Compass
RecruitingEarly Phase 1
[18F]ACI-15916 PET in α-synucleinopathies
Sweden46 participantsStarted 2025-03-20
Plain-language summary
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.
Who can participate
Age range
20 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
. For subjects receiving arterial cannulation, an adequate circulation to the hand for safe placement of arterial line (as determined by Allen's test).
. Males and females aged ≥ 20 at the time of signing the informed consent.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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)
Timeframe: From Informed Consent Signature (screening) to safety phone call after PET scan (i.e. up to 14 weeks in total)
2
Number of participants with clinically significant changes in vital signs measurements
Timeframe: During PET scan visit (i.e. at Day 0): before [18F]ACI-15916 injection and after the PET scan is completed
3
Brain uptake of the tracer [18F]ACI-15916
Timeframe: At the time of the [18F]ACI-15916 PET scan (i.e. at Day 0): 0-93 minutes after injection
. Normal MRI and DAT PET or SPECT (except for Part 4 participants), as judged by the investigator.
. The subject is, in the opinion of the investigator, generally healthy based on the assessment of medical history, physical examination, vital signs, ECG, and the results of the hematology, clinical chemistry, urinalysis, serology, and other laboratory tests.
Exclusion criteria
5. 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.
6. 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.
. Female subjects pregnant, lactating or breastfeeding.
. Presence of psychiatric symptoms that may interfere with the objectives of the study, as judged by the investigator.
. Clinically significant concomitant disease or condition within 6 months prior to screening, that could interfere with the conduct of the study, or that would, in the opinion of the investigator, pose an unacceptable risk to the participant, or compromise the scientific quality of the study.
. History of brain surgery or any neurosurgical procedures. Subject has received treatment with a drug, antibody or vaccine targeting α-synuclein.
. Known or suspected drug, alcohol or other abuse, or positive urine drug screen which may interfere with the study objective, as judged by the investigator.
. History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity as judged by the investigator.