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ACI-15916

Phase 1

Parkinson's Disease (PD) | Unknown | Neurology |AC Immune SA|Last Updated: Nov 19, 2025

Success Probability

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Trial Design

ACTIVE_CONTROLLED
Total Trials1
Total Enrollment46

FDA Designations

No designations recorded

Clinical trial landscape

ACI-15916 · 1 trial · 3 indications

Early Phase 1 1
NCT06891703[18F]ACI-15916 PET in α-synucleinopathiesParkinson's Disease (PD)
RECRUITING46 Analytics
EARLY_PHASE1RECRUITING
[18F]ACI-15916 PET in α-synucleinopathies
Parkinson's Disease (PD)Unlock trial analytics

Study Endpoints

Primary Endpoints

Number of participants with Adverse Events (AEs) assessed by severity (mild, moderate, severe, life threatening, death) and causal relationship (not related, unlikely related, possibly related or related)
From Informed Consent Signature (screening) to safety phone call after PET scan (i.e. up to 14 weeks in total)
Number of participants with clinically significant changes in vital signs measurements
During PET scan visit (i.e. at Day 0): before [18F]ACI-15916 injection and after the PET scan is completed

Vital signs measurements will be performed after the PET scan is completed and will be compared with measurements performed before the injection of \[18F\]ACI-15916

Brain uptake of the tracer [18F]ACI-15916
At the time of the [18F]ACI-15916 PET scan (i.e. at Day 0): 0-93 minutes after injection

\[18F\]ACI-15916 uptake in relevant regions of interest of the brain will be measured with PET scan and the mean of each group (participants with α-synucleinopathies and healthy volunteers) will be calculated

Secondary Endpoints

Assessment of simplified methods to quantify brain uptake of the tracer [18F]ACI-15916
At the time of the [18F]ACI-15916 PET scan (i.e. at Day 0): 0-93 minutes after injection
Variability of the tracer brain uptake between two [18F]ACI-15916 PET scans (test/retest)
From the first PET scan (i.e. Day 0) to the second PET scan (i.e. Day 30)
Radiation dosimetry after one [18F]ACI-15916 PET scan
At the time of the [18F]ACI-15916 PET scan (i.e. at Day 0): 0-6 hours after injection
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeDIAGNOSTIC

Treatment Arms

ArmTypeDescription
Participants with suspected α-synucleinopathiesEXPERIMENTALThe study population will be composed of participants with suspected α-synucleinopathies
Healthy volunteersACTIVE_COMPARATORThe study population will be composed of healthy volunteers

Interventions

NameTypeDescription
[18F]ACI-15916OTHER\[18F\]ACI-15916 is an intravenously administered radioactive imaging agent being studied as a potential positron emitting radiopharmaceutical for in vivo imaging of α-synuclein deposits.
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Eligibility Criteria

Age Range20 Years to N/A
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria for all Participants: 1. Subject is able to provide written informed consent, which must be obtained before any assessment is performed. 2. Subjects must be able to understand and be willing to comply with study procedures, restrictions, and requirements. 3. Body mass index is \>...

Countries:Sweden
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Frequently asked questions about ACI-15916

What is ACI-15916 used for in Parkinson's Disease?

ACI-15916 is an investigational diagnostic agent being studied for use in Parkinson's Disease (PD), as well as in related conditions including Multiple System Atrophy (MSA) and Dementia With Lewy Bodies (DLB). It is currently in early Phase 1 clinical development for these α-synucleinopathies.

What does ACI-15916 target?

ACI-15916 is a positron emission tomography (PET) imaging agent designed to target α-synuclein, the protein that accumulates in Parkinson's Disease and other α-synucleinopathies. It is being developed to enable visualization of α-synuclein pathology in the brain.

Who makes ACI-15916?

ACI-15916 is being developed by AC Immune SA, a biopharmaceutical company traded on NASDAQ under the ticker ACIU. The company is conducting clinical research on this agent for imaging α-synuclein in neurological conditions.

What phase is ACI-15916 in?

ACI-15916 is in early Phase 1 clinical development. It is an investigational agent and has not been approved by regulatory authorities. The ongoing trial is in the recruiting stage, with an enrollment target of 46 participants.

What clinical trials is ACI-15916 in?

ACI-15916 is being studied in a single early Phase 1 clinical trial registered as NCT06891703, titled "[18F]ACI-15916 PET in α-synucleinopathies." This actively recruiting study is being conducted in Sweden and includes healthy volunteers as well as patients with Parkinson's Disease, Multiple System Atrophy, and Dementia With Lewy Bodies.

Is ACI-15916 the same as [18F]ACI-15916?

Yes, ACI-15916 is also known as [18F]ACI-15916, which refers to the radiolabeled form of the compound used in positron emission tomography (PET) imaging. The clinical trial NCT06891703 specifically evaluates [18F]ACI-15916 as a PET tracer for α-synucleinopathies.