Actively Recruiting
[18F]ACI-19626 PET in TDP-43 Proteinopathies
Led by AC Immune SA · Updated on 2025-03-24
45
Participants Needed
1
Research Sites
92 weeks
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
The goal of this clinical trial is to test whether we can reliably and safely measure the accumulation of pathological protein TDP-43 \[involved in rare forms of dementia such as frontotemporal dementia (FTD) and in amyotrophic lateral sclerosis (ALS)\] using a new positron emission tomography (PET) tracer called \[18F\]ACI-19626. Both healthy people and people with (suspected) TDP-43 accumulation will participate to this trial. The main questions it aims to answer are: * whether \[18F\]ACI-19626 is safe and well tolerated when injected into participants * whether \[18F\]ACI-19626 reliably detects abnormal TDP-43 in the brain using PET technique. * whether there are differences in the amount of this protein between people with diseases related to TDP-43 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 MRI in some cases). * Visit the clinic to receive the tracer \[18F\]ACI-19626 intravenously and be scanned in a PET scanner, during which blood will be collected. * Receive a phone call from the clinic 2 to 4 days 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, allowing the researchers to determine if the measurements with the first PET scan are stable and reproducible.
CONDITIONS
Official 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 agree to use reliable contraception and not donate eggs for 30 days after PET scan
- Male participants with partners of childbearing potential must use barrier contraception and not donate sperm during study and 90 days after PET scan
- Willing and able to cooperate with study procedures
- Able to tolerate lying in scanner for up to 90 minutes without excessive movement, or up to 120 minutes with a break
- For arterial cannulation, adequate hand circulation and normal coagulation tests required
- Healthy controls aged 40-70 years with no neurological or psychiatric disorders, no family history of TDP-43 proteinopathies, normal MRI and cognitive assessment
- Participants with TDP-43 proteinopathies aged 40 years or older with diagnosis of FTD, ALS, or other related neurodegenerative diseases confirmed genetically or by MRI consistent with diagnosis
You will not qualify if you...
- History of alcohol or drug abuse in past 2 years
- Significant abnormal laboratory tests or unstable medical conditions
- Known hypersensitivity to [18F]ACI-19626 or its excipients
- Recent participation in other research involving excessive radiation exposure
- Pregnant or lactating women
- Clinically significant gastrointestinal, cardiovascular, liver, kidney, blood, cancer, endocrine, neurological, immune, lung, or other disorders
- Unsuitable veins for repeated blood draws
- Implanted medical devices not certified for MRI or claustrophobia
- Recent treatment with antihemostasis medications before arterial cannulation
- Clinically significant anemia or coagulopathies for arterial cannulation
- Recent blood loss or donation over 500 mL within 4 months before study visits
- Recent investigational drug use unless placebo only
- Prior disease-modifying therapy trials affecting TDP-43 metabolism unless placebo only
- MRI showing alternative pathology not consistent with TDP-43 proteinopathies
- Mutations known to lack TDP-43 pathology such as SOD1 or FUS
AI-Screening
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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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