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Study identifier: NCT06891716 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

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

Condition: Frontotemporal Dementia (FTD) · Amyotrophic Lateral Sclerosis (ALS) · TDP-43 Proteinopathies  ·  Sponsor: AC Immune SA

PhaseEARLY_Phase 1
Planned participants45
Who can joinAll sexes, 40 Years to 70 Years
Healthy volunteersYes

About this study

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 stabl…

This description comes directly from the study's public registry record.

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Locations (1)

Amsterdam UMCAmsterdam, NetherlandsRecruiting

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Source record: clinicaltrials.gov/study/NCT06891716