Clinical trial • Phase I • Neurology
[18F]ACI-15916 for Parkinson's disease|Dementia with Lewy bodies|Multiple system atrophy
Phase I trial of [18F]ACI-15916 for Parkinson's disease|Dementia with Lewy bodies|Multiple system atrophy. 46 participants.
Overview
- Trial Therapeutic Area
- Neurology
- Trial Disease
- Parkinson's disease|Dementia with Lewy bodies|Multiple system atrophy
- Trial Stage
- Phase I
- Drug Modality
- Radiopharmaceutical
Key dates
- Initial CTIS Submission Date
- 31-10-2024
- First CTIS Authorization Date
- 26-02-2025
Trial design
Phase I trial across 1 site in Sweden.
- Target Sample Size
- 46
Eligibility
Recruits 46 Vulnerable population selected (isVulnerablePopulationSelected=true) in Part I. No further details on consent/assent handling are provided in the supplied documents..
- Vulnerable Population
- Vulnerable population selected (isVulnerablePopulationSelected=true) in Part I. No further details on consent/assent handling are provided in the supplied documents.
Recruitment
- Planned Sample Size
- 46
- Recruitment Window Months
- 13
- Consent Approach
- Not specified in provided documents. Public/scientific contact: 'Clinical Trial Information' (clinicaltrials@acimmune.com).
Geography
- Total Number Of Sites
- 1
- Total Number Of Participants
- 46
Sweden
- Earliest CTIS Part Ii Submission Date
- 07-02-2025
- Latest Decision Or Authorization Date
- 25-07-2025
- Processing Time Days
- 168
- Number Of Sites
- 1
- Number Of Participants
- 46
Sites
- Site Name
- Karolinska Institutet
- Department Name
- Clinical Neuroscience
- Contact Person Name
- Andrea Varrone
- Contact Person Email
- andrea.varrone@ki.se
Sponsor
Primary sponsor
- Full Name
- AC Immune S.A.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Switzerland
Investigational products
- Investigational Product Name
- [18F]ACI-15916
- Active Substance
- [18F]ACI-15916
- Modality
- Radiopharmaceutical
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