Actively Recruiting
Phase 1 Study to Evaluate [18F]ACI-19626 as a PET Radioligand for Imaging TDP-43 in Patients With Suspected TDP-43 Proteinopathies Compared With Healthy Controls
Led by AC Immune SA · Updated on 2025-03-24
45
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
A
AC Immune SA
Lead Sponsor
A
Amsterdam UMC, location VUmc
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating a new imaging method to detect the accumulation of a protein called TDP-43, which is linked to rare brain diseases like frontotemporal dementia (FTD) and amyotrophic lateral sclerosis (ALS). The study aims to see if the new PET tracer, called [18F]ACI-19626, is safe when injected and if it can reliably show abnormal TDP-43 in the brain. The study includes both healthy people and those suspected of having TDP-43 protein buildup to compare differences. The study involves up to 45 participants split into groups: healthy controls, symptomatic gene mutation carriers with FTD, and patients with other TDP-43 related diseases. Participants receive an intravenous injection of [18F]ACI-19626 followed by a PET scan to track the tracer's brain uptake. Some participants may have a second PET scan within a month to check if the results are consistent. The study lasts up to 3 months, including screening, scanning, and follow-up. During the study, participants will undergo physical and neurological exams, questionnaires, blood and urine tests, ECGs, and sometimes MRI scans to confirm eligibility and health status. After the PET scan, blood samples are taken, and participants receive a phone call 2 to 4 days later to monitor any side effects. The main measurements include safety assessments, brain uptake of the tracer, and how well the scans can quantify TDP-43. The study also evaluates radiation exposure and tracer consistency between scans.
CONDITIONS
Brief Title
[18F]ACI-19626 PET in TDP-43 Proteinopathies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to provide written informed consent before any assessments
- Female participants must not be of childbearing potential or must agree to use reliable contraception and avoid egg donation during the study and 30 days after the PET scan
- Male participants must agree to use barrier contraception and avoid sperm donation during the study and 90 days after the PET scan
- Willing and able to cooperate with study procedures
- Able to lie still in the scanner for up to 90 minutes (or 120 minutes with a break)
- For those receiving arterial cannulation, adequate hand circulation and normal blood clotting tests
- Healthy controls aged 40-70 years with no relevant neurological or psychiatric disorders, no family history of TDP-43 proteinopathies, and cognitive score (MoCA) of 26 or higher
- Participants with TDP-43 proteinopathies aged 40 years or older with specific diagnoses including genetic mutation carriers or sporadic forms of FTD, ALS, or related diseases
- Confirmed genetic status for genetic participants with FTD, FTD-MND, or ALS
- MRI consistent with diagnosis for sporadic FTD/FTD-MND participants
You will not qualify if you...
- History of alcohol or drug abuse within the past 2 years
- Clinically significant abnormal lab tests or unstable medical conditions
- Known hypersensitivity to [18F]ACI-19626 or related substances
- Radiation exposure exceeding annual limits from other studies in past year
- Pregnant or breastfeeding
- Significant gastrointestinal, cardiovascular, liver, kidney, blood, cancer, endocrine, neurological, immune, lung, or other disorders
- Unsuitable veins for repeated blood draws
- MRI-incompatible implants or claustrophobia
- Recent use of blood-thinning medications before arterial cannulation
- Significant anemia or blood clotting disorders
- Blood donation or loss over 500 mL within 4 months prior to study visits for those undergoing arterial cannulation
- Recent investigational drug use unless placebo only
- For TDP-43 proteinopathy participants: prior disease-modifying therapy trials affecting TDP-43, MRI showing alternative pathology, or mutations known to lack TDP-43 pathology such as SOD1 or FUS
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for informed consent and eligibility assessments
Duration - Up to 1 day
Participants undergo PET scans using the [18F]ACI-19626 radiotracer to assess brain uptake and safety.
1 PET scan visit lasting up to 90 minutes
Duration - Up to 3 months
Participants are monitored for safety and adverse events for up to 3 months after the PET scan.
Safety phone call(s) after the PET scan
Duration - Up to 1 day
A subset of participants may have an additional PET scan within 1 month to assess test-retest reliability.
1 additional PET scan visit within 1 month of the first scan
Trial Site Locations
Total: 1 location
1
Amsterdam UMC
Amsterdam, Netherlands
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
2
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