Early phase 1Recruiting
[18F]ACI-19626 PET in TDP-43 Proteinopathies
Phase 1 Study to Evaluate [18F]ACI-19626 as a Potential PET Radioligand for Imaging TDP-43 Inclusions in the Brain of Patients With Suspected TDP-43 Proteinopathies Compared With Healthy Controls
- Sponsor
- AC Immune SA (Industry)
- Enrolment
- 45 planned
- Conditions
- Frontotemporal Dementia (FTD); Amyotrophic Lateral Sclerosis (ALS); TDP-43 Proteinopathies; Suspected Limbic Predominant Age-related TDP-43 Encephalopathy (LATE); Alzheimer's Disease (AD)
- Interventions
- [18F]ACI-19626
- Ages
- adults, older adults
- Registry
- NCT06891716
From the registry
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…
Primary outcomes
- Number of participants with Adverse Events (AEs) assessed by severity (mild, moderate or severe) and causal relationship (unrelated, unlikely, possibly or probably related)
- Number of participants with clinically significant changes in vital signs measurements
- Brain uptake of the tracer [18F]ACI-19626
- Assessment of the optimal kinetic model quantification of [18F]ACI-19626 tracer uptake