A Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO7812653 in Participants With Early Symptomatic Alzheimer's Disease (eAD)
Condition(s) studied
Investigational drug(s) / intervention(s)
RO7812653: Participants will receive RO7812653 as per the schedule in the protocol
Placebo: Participants will receive placebo as per the schedule in the protocol
Study summary
This study aims to evaluate the safety, tolerability, immunogenicity, pharmacokinetics, and pharmacodynamics following administration of RO7812653 in participants with eAD.
Eligibility
Primary outcome measure(s)
- Percentage of Participants with Adverse Events — Up to approximately 40 weeks
- Change From Baseline in Columbia-Suicide Severity Rating Scale (C-SSRS) Scores — Up to approximately 40 weeks
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.
Trial sites (12)
| Facility | City | Region | Status |
|---|---|---|---|
| Toronto Western Hospital | Toronto | Ontario | |
| Montreal Neurological Institute Clinical Research Unit | Montreal | Quebec | |
| Brain Research Center Amsterdam | Amsterdam | North Holland | |
| Hospital General de Catalunya | Sant Cugat del Vallès | Barcelona | |
| 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 | |
| Southampton General Hospital | Southampton | Hampshire | |
| Queen Elizabeth Hospital | Glasgow | Strathclyde | |
| National Hospital For Neurology and Neurosurgery | London | United Kingdom |
More Hoffmann-La Roche trials in the UK
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07234942 on ClinicalTrials.gov ↗ ← All trials in the UK