RecruitingEarly Phase 1NCT06891703

[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

Enrollment

46 participants

Start Date

Mar 20, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 20 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new PET scan imaging agent called [18F]ACI-15916 that may be able to detect a harmful protein called alpha-synuclein in the brain. Alpha-synuclein buildup is linked to diseases like Parkinson's and Lewy body dementia. This study aims to see how well the new tracer shows up in people with these conditions versus healthy volunteers. **You may be eligible if...** - You have been diagnosed with a condition involving alpha-synuclein (such as Parkinson's disease or Lewy body dementia), OR you are a healthy volunteer - Your body weight and BMI fall within the required range (50–100 kg, BMI 18–31) - Women must not be able to become pregnant or must use highly effective contraception **You may NOT be eligible if...** - You fall outside the required weight or BMI range - You are pregnant or unwilling to use contraception - You have metal implants or other contraindications to the procedures involved Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

OTHER[18F]ACI-15916

\[18F\]ACI-15916 is an intravenously administered radioactive imaging agent being studied as a potential positron emitting radiopharmaceutical for in vivo imaging of α-synuclein deposits.


Locations(1)

Karolinska Institutet

Solna, Sweden

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06891703


Related Trials