Phase 1 study to evaluate [18F]ACI-15916 as a potential PET radioligand for imaging α-synuclein deposits in the brain of patients with suspected α-synuclein pathology compared with healthy volunteers

Start 4 Mar 2025 · Status Ongoing, recruiting · 1 EU/EEA countries · 1 sites · Protocol ACI-15916-PD-2401

Overview

Sponsor-declared trial summary

Phase Human pharmacology (Phase I) - First administration to humans

Status Ongoing, recruiting

Participants planned 46

Countries 1

Sites 1

Parkinson's Disease

Key facts

Sponsor: AC Immune S.A.
Participant type: Patients, Healthy volunteers
Age range: 18-64 years, 65+ years
Gender: Male and Female
Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trial duration: 4 Mar 2025 → ongoing
Decision date (initial): 2025-02-26
Transition trial: No
Low-intervention: No
Rare-disease indication: No
Vulnerable population: Yes

Trial design

CTIS Part I — objectives, methods, condition coding

Conditions and MedDRA coding

Parkinson's Disease

Version	Level	Code	Term	System organ class
21.1	PT	10064060	Multiple system atrophy	100000004852
20.0	PT	10061536	Parkinson's disease	100000004852
20.0	PT	10067889	Dementia with Lewy bodies	100000004852

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

AC Immune S.A.

Sponsor organisation: AC Immune S.A.
Address: Batiment B Epfl Innovation Park
City: Lausanne
Postcode: 1015
Country: Switzerland

Scientific contact point

Organisation: AC Immune S.A.
Contact name: Clinical Trial Information

Public contact point

Organisation: AC Immune S.A.
Contact name: Clinical Trial Information

Locations

1 EU/EEA country · 1 investigational sites

By country

Country	MS status	Planned subjects	Sites
Sweden	Ongoing, recruiting	46	1
Rest of world	—	0	—

Investigational sites

Sweden

1 site · Ongoing, recruiting

Karolinska Institutet

Clinical Neuroscience, Nobels Vag 6, 171 65, Solna

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Country	Trial start	Trial end	Recruitment start	Recruitment end	Early termination
Sweden	2025-03-04		2025-03-20

Application history

2 submissions — initial application plus substantial / non-substantial modifications

#	Type	Code	Submitted	Reference MS	Conclusion	Decision date
1	INITIAL	IN	2024-10-31	Sweden	Acceptable 2025-02-25	2025-02-26
2	SUBSTANTIAL MODIFICATION	SM-1	2025-06-18	Sweden	Acceptable 2025-07-22	2025-07-25