Calendario›ACIU›[18F]ACI-19626 PET in TDP-43 Proteinopathies
[18F]ACI-19626 PET in TDP-43 Proteinopathies
Ensayo de AC Immune SA en Demencia frontotemporal (FTD) · Esclerosis lateral amiotrofica (ALS) · Proteinopatias TDP-43 · Encefalopatia TDP-43 predominante limbica relacionada con la edad sospechada (LATE) · Enfermedad de Alzheimer (AD).
- Fase
- Fase 1 temprana
- Estado
- Reclutando pacientes
- Participantes
- 45
- Centros
- 1
- Fin del objetivo primario
- nov 2026
Qué significa cada fase y cada estado.
Estudio de intervención, no aleatorizado, abierto. Comenzó en ene 2025.
Qué mide
Numero de participantes con acontecimientos adversos (AE) evaluados por gravedad (leve, moderada o grave) y relacion causal (no relacionado, improbable, posiblemente o probablemente relacionado) (From Informed Consent Signature (screening) to safety phone call after PET scan (i.e. up to 3 months in total)) (del registro, en inglés)
Qué se prueba
Se prueba si un nuevo trazador PET puede medir de forma fiable y segura la acumulacion de la proteina TDP-43 en personas sanas y en personas con sospecha de esta acumulacion.
Lo que dice el documentotest 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.
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Cómo lo describe el promotor
En el documentoEn inglés, del registroThe 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.
Más ensayos de ACIU
| Ensayo | Fase | Estado | Lectura de resultados |
|---|---|---|---|
| [18F]ACI-15916 PET in α-synucleinopathies | Fase 1 temprana | Reclutando pacientes | mar 2026 (prevista, ya pasada: sin actualizar en el registro) |
| ACI-19764 at dose A1 | Fase 1 | Reclutando pacientes | dic 2026 (prevista) |
| ACI-7104.056 at Dose A · VacSYn | Fase 2 | En marcha, sin reclutar | jun 2028 (prevista) |
| ACI-24.060 at Dose A in Study… | Fase 1/2 | Reclutando pacientes | abr 2029 (prevista) |
| ACI-24 | Fase 2 | Retirado antes de empezar | abr 2024 (prevista, ya pasada: sin actualizar en el registro) |
| ACI-35.030 | Fase 1/2 | Completado | sep 2023 (real) |
Todos los de ACIU, en su ficha.
Ficha completa en ClinicalTrials.gov (NCT06891716), actualizada en ago 2026.