Clinical trial • Phase I • Neurology

[18F]ACI-19626 for Alzheimer's disease | Amyotrophic lateral sclerosis | Frontotemporal dementia | Limbic-predominant age-related TDP-43 encephalopathy (LATE)

Phase I trial of [18F]ACI-19626 for Alzheimer's disease | Amyotrophic lateral sclerosis | Frontotemporal dementia | Limbic-predominant age-related TDP-43…

Overview

Trial Therapeutic Area
Neurology
Trial Disease
Alzheimer's disease | Amyotrophic lateral sclerosis | Frontotemporal dementia | Limbic-predominant age-related TDP-43 encephalopathy (LATE)
Trial Stage
Phase I
Drug Modality
Radiopharmaceutical

Key dates

Initial CTIS Submission Date
29-07-2024
First CTIS Authorization Date
30-10-2024

Trial design

Phase I trial across 1 site in Netherlands.

Target Sample Size
45
Trial Duration For Participant
730

Recruitment

Planned Sample Size
45
Recruitment Window Months
24

Geography

Total Number Of Sites
1
Total Number Of Participants
45

Netherlands

Earliest CTIS Part Ii Submission Date
27-09-2024
Latest Decision Or Authorization Date
01-04-2025
Processing Time Days
186
Number Of Sites
1
Number Of Participants
45

Sites

Site Name
Amsterdam UMC
Department Name
Radiology and Nuclear Medicine
Contact Person Name
Elsmarieke van de Giessen

Sponsor

Primary sponsor

Full Name
AC Immune SA
Organisation Type
Pharmaceutical company
Country Of Registered Address
Switzerland

Investigational products

Investigational Product Name
[18F]ACI-19626
Active Substance
[18F]ACI-19626
Modality
Radiopharmaceutical

Related trials

Other published trials that may interest you.