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

NCT06891716 · Status: RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2025-03-24

No results posted yet for this study

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.

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

OTHER

[18F]ACI-19626

\[18F\]ACI-19626 is an intravenously administered radioactive imaging agent being studied as a potential positron emitting radiopharmaceutical for in vivo imaging of TDP-43 deposits.

Sponsors & Collaborators

  • Amsterdam UMC, location VUmc

    collaborator OTHER

  • AC Immune SA

    lead INDUSTRY

Principal Investigators

  • Elsmarieke van de Giessen, MD · Amsterdam UMC

  • Clinical Lead · AC Immune SA

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-01-21
Primary Completion
2026-11-30
Completion
2026-11-30

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06891716 on ClinicalTrials.gov