Clinical trial • Phase I • Neurology

RO7812653 for Early symptomatic Alzheimer's disease | Mild cognitive impairment due to Alzheimer's disease | Alzheimer's disease dementia

Phase I trial of RO7812653 for Early symptomatic Alzheimer's disease | Mild cognitive impairment due to Alzheimer's disease | Alzheimer's disease dementia.

Overview

Trial Therapeutic Area
Neurology
Trial Disease
Early symptomatic Alzheimer's disease | Mild cognitive impairment due to Alzheimer's disease | Alzheimer's disease dementia
Trial Stage
Phase I

Key dates

Initial CTIS Submission Date
07-08-2025
First CTIS Authorization Date
02-12-2025

Trial design

None/Not specified-controlled Phase I trial across 10 sites in Spain, Sweden, Netherlands and others.

Comparator
None/Not specified
Target Sample Size
70

Eligibility

Recruits 70 No vulnerable populations selected (isVulnerablePopulationSelected=false). No specific consent/assent handling described in the record..

Vulnerable Population
No vulnerable populations selected (isVulnerablePopulationSelected=false). No specific consent/assent handling described in the record.

Recruitment

Planned Sample Size
70
Recruitment Window Months
45

Geography

Total Number Of Sites
10
Total Number Of Participants
117

Spain

Earliest CTIS Part Ii Submission Date
19-11-2025
Latest Decision Or Authorization Date
03-12-2025
Processing Time Days
14
Number Of Sites
4
Number Of Participants
50

Sites

Site Name
Hospital Universitari General De Catalunya
Department Name
Neurology
Contact Person Name
Ernest Balaguer Martinez
Contact Person Email
e.balaguer@udic.es
Site Name
Hospital Universitario Reina Sofia
Department Name
Neurology
Contact Person Name
Eduardo Aguera Morales
Contact Person Email
doctoredu@gmail.com
Site Name
Hospital De La Santa Creu I Sant Pau
Department Name
Neurology
Contact Person Name
Juan Fortea Ormaechea
Contact Person Email
jfortea@santpau.es
Site Name
Fundacio Ace Institut Catala De Neurociencies Aplicades
Department Name
Neurology
Contact Person Name
Merce Boada Rovira
Contact Person Email
mboadatrials@fundacioace.org

Sweden

Earliest CTIS Part Ii Submission Date
12-11-2025
Latest Decision Or Authorization Date
04-12-2025
Processing Time Days
22
Number Of Sites
2
Number Of Participants
24

Sites

Site Name
Sahlgrenska University Hospital-Vaestra Goetalandsregionen
Department Name
Sahlgrenska Universitetssjukhuset
Contact Person Name
Michael Jonsson
Contact Person Email
michael.jonsson@neuro.gu.se
Site Name
Karolinska University Hospital
Department Name
Karolinska Universitetssjukhuset
Contact Person Name
Pia Andersen

Netherlands

Earliest CTIS Part Ii Submission Date
24-11-2025
Latest Decision Or Authorization Date
02-12-2025
Processing Time Days
8
Number Of Sites
1
Number Of Participants
12

Sites

Site Name
Brain Research Center Amsterdam B.V.
Department Name
Neurology
Contact Person Name
Jort Vijverberg

Poland

Earliest CTIS Part Ii Submission Date
12-11-2025
Latest Decision Or Authorization Date
08-12-2025
Processing Time Days
26
Number Of Sites
3
Number Of Participants
31

Sites

Site Name
Centrum Medyczne Neuroprotect
Contact Person Name
Maciej Czarnecki
Contact Person Email
marta.biel@neuroprotect.pl
Site Name
Revit Sp. z o.o.
Department Name
Podlaskie Centrum Psychogeriatrii
Contact Person Name
Jacek Dobryniewski
Contact Person Email
jacekdobryniewski@gmail.com
Site Name
Krakowska Akademia Neurologii Sp. z o.o.
Contact Person Name
Monika Rudzińska-Bar
Contact Person Email
olga.fraczek@neurologia.org.pl

Sponsor

Primary sponsor

Full Name
F. Hoffmann-La Roche AG
Organisation Type
Pharmaceutical company
Country Of Registered Address
Switzerland

Investigational products

Investigational Product Name
RO7812653
First In Human
Yes

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