This study aims to evaluate the safety, tolerability, immunogenicity, pharmacokinetics, and pharmacodynamics following administration of RO7812653 in participants with eAD.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
6
Toronto Western Hospital
Toronto, Ontario, Canada
Montreal Neurological Institute Clinical Research Unit
Montreal, Quebec, Canada
Brain Research Center Amsterdam
Amsterdam, North Holland, Netherlands
Percentage of Participants with Adverse Events
Time frame: Up to approximately 40 weeks
Change From Baseline in Columbia-Suicide Severity Rating Scale (C-SSRS) Scores
C-SSRS measures 4 constructs as follows: severity of ideation, intensity of ideation, behavior, and lethality of actual suicide attempts. Binary (yes/no) data are collected for 10 categories. Numeric ratings are provided for intensity of ideation (if present), from 1 to 5, with 1 being the least severe and 5 being the most severe.
Time frame: Up to approximately 40 weeks
Plasma Concentration of RO7812653
Time frame: Up to approximately 40 weeks
Cerebral Spinal Fluid (CSF) Concentration of RO7812653
Time frame: Up to approximately 40 weeks
Percentage of Participants with Anti-Drug Antibodies (ADAs) to RO7812653
Time frame: Up to approximately 40 weeks
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Hospital General de Catalunya
Sant Cugat del Vallès, Barcelona, Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, Spain
Hospital Universitario Reina Sofia
Córdoba, Spain
Sahlgrenska Universitetssjukhuset, Mlndal Sjukhus
Mlndal, Sweden
Karolinska Universitetssjukhuset
Solna, Sweden
Institute of Psychiatry, Psychology and Neuroscience;Department of Old Age Psychiatry
London, Greater London, United Kingdom
Southampton General Hospital
Southampton, Hampshire, United Kingdom
...and 2 more locations