Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 7:39 PM
Ignite Modification Date:
2025-12-24 @ 7:39 PM
NCT ID:
NCT06891703
Brief Summary:
The 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.
Detailed Description:
This is an open-label, first in human (FiH) positron emission tomography (PET) microdose study in patients with suspected α-synuclein pathology and healthy volunteers (HVs) using \[18F\]ACI-15916 as a novel radioligand. This study will be dedicated to qualification of the ligand \[18F\]ACI-15916 to measure α-synuclein pathology using PET investigations, including estimation of effective dose and test-retest reliability.
The study consists of four parts in which a total of up to 46 participants may be included:
* Part 1: Up to 5 HVs and up to 5 patients with Parkinson's Disease (PD) will be included.
* Part 2: Up to 30 additional subjects including: HV cases (maximum 10) and patients with α-synucleinopathies such as PD, Multiple System Atrophy (MSA) and Dementia with Lewy Bodies (DLB).
* Part 3: Up to 10 participants from Part 1 and/or Part 2 will have a second PET measurement within one month after their initial PET measurement to evaluate test-retest variability and reproducibility.
* Part 4. Up to 6 HVs (3 female and 3 male) will undergo a whole-body PET-CT examination to estimate the effective dose after one administration of \[18F\]ACI-15916.
The four study parts can overlap.
The study consists of a screening period of up to 60 days to assess participants' eligibility, a PET scan with \[18F\]ACI-15916 along with arterial blood sampling, and a safety phone call following the scanning visit. For participants in Part 3, a second PET scan with \[18F\]ACI-15916 will be performed up to one month after the first scan to evaluate test-retest variability and reproducibility, followed by a new safety phone call. For subjects in Part 4 (dosimetry), no arterial blood sampling will be performed. The total study duration will be up to 10 weeks for Part 1, 2 and 4 participants and up to 14 weeks for Part 3 participants.
Study:
NCT06891703
Study Brief:
Protocol Section:
NCT06891703