Clinical Trial

[18F]ACI-19626 PET in TDP-43 Proteinopathies

Recruiting Early Phase 1
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Summary
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.
Trial Details
NCT Number NCT06891716
Lead Sponsor AC Immune SA
Collaborators: Amsterdam UMC, location VUmc
Conditions Frontotemporal Dementia (FTD), Amyotrophic Lateral Sclerosis (ALS), TDP-43 Proteinopathies, Suspected Limbic Predominant Age-related TDP-43 Encephalopathy (LATE), Alzheimer's Disease (AD)
Enrollment 45 participants
Start Date 2025-01-21
Primary Completion 2026-11 (estimated)
Study Completion 2026-11 (estimated)
Updated on ClinicalTrials.gov 2025-03-24