Calendario›ACIU›[18F]ACI-15916 PET in α-synucleinopathies

[18F]ACI-15916 PET in α-synucleinopathies

Ensayo de AC Immune SA en Enfermedad de Parkinson (EP) · Atrofia multisistemica (AMS) · Demencia con cuerpos de Lewy (DCL).

Fase

Fase 1 temprana

Estado

Reclutando pacientes

Participantes

46

previstos

Centros

1

Fin del objetivo primario

mar 2026

estimado por el promotor

Qué significa cada fase y cada estado.

Estudio de intervención, no aleatorizado, abierto. Comenzó en mar 2025.

Qué mide

Numero de participantes con acontecimientos adversos (AA) evaluados por gravedad (leve, moderada, grave, potencialmente mortal, muerte) y relacion causal (no relacionado, poco probablemente relacionado, posiblemente relacionado o relacionado) (From Informed Consent Signature (screening) to safety phone call after PET scan (i.e. up to 14 weeks in total)) (del registro, en inglés)

Qué se prueba

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 α-synuclein \[involved in some diseases such as Parkinson's disease, Lewy body dementia and Multiple System Atrophy (MSA), collectively named α-synucleinopathies\] using a new positron emission tomography (PET) tracer called \[18F\]ACI-15916. Both healthy people and people with (suspected) α-synuclein pathology will participate to this trial. The main questions it aims to answer are: * whether \[18F\]ACI-15916 is safe and well tolerated when injected into participants * whether \[18F\]ACI-15916 reliably detects α-synuclein in the brain using PET technique. * whether there are differences in the amount of this protein between people with diseases related to α-synuclein 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 in some cases a MRI and a PET scan with a licensed tracer (\[18F\]FE-PE2I) to confirm or not the disease\]. * Visit the clinic to receive the tracer \[18F\]ACI-15916 intravenously and be scanned in a PET scanner, during which blood will be collected (and optionally spinal fluid). * Receive a phone call from the clinic 1 week 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 with \[18F\]ACI-15916, allowing the researchers to determine if the measurements with the first PET scan are stable and reproducible. Some of the participants will participate in a specific part of the study to evaluate the distribution of the PET ligand in the whole body, with a similar visit schedule.

Más ensayos de ACIU

Todos los de ACIU, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT06891703), actualizada en nov 2025.