BP45770
Research type
Research Study
Full title
A Phase I, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Single Ascending Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO7812653 Following Intrathecal Administration in Participants with Early Symptomatic Alzheimer’s Disease
IRAS ID
1012605
Contact name
Head of Clinical Trial Regulatory Management
Contact email
Sponsor organisation
F. Hoffmann-La Roche Ltd
Eudract number
2025-522101-37
ISRCTN Number
ISRCTN10651912
Research summary
Apolipoprotein E, or ApoE, is a protein in the body that helps transport fats and cholesterol. In Alzheimer's disease (AD), which affects memory and thinking, ApoE doesn't work as well as it should. This can lead to the build-up of harmful substances in the brain, which interfere with how brain cells communicate. This study is testing a medicine called RO7812653, which aims at reducing levels of ApoE in the brain. This study aims to test how safe RO7812653 is (at different doses) and to understand what happens to RO7812653 once it is in the body. Up to about 50 participants who have a diagnosis of probable AD dementia or Mild Cognitive Impairment due to AD between 50 and 75 years old are planned to be enrolled. People who are pregnant, or currently breastfeeding cannot take part in the study. Potential participants will undergo screening tests (up to 8 weeks) to confirm that they are eligible. Everyone who joins this study will be split up into 2 groups randomly (like flipping a coin) and receive either RO7812653, or placebo (dummy medication) and means that this study is a ‘placebo-controlled’ study. It is a double-blinded study, which means that neither the participants in the study nor the team running it will know which treatment is being given until the study is over. The study treatment will be given as an injection into the lower back directly into the space around the spinal cord and will occur on visit 1, then participants will enter a safety follow up period that will consist of 11 to 12 visits to the study centre. The main results measured are to assess if RO7812653 is safe in terms of number and seriousness of adverse events, number and seriousness of abnormal laboratory results, abnormal vital signs, and cardiac parameters, MRI findings, and to assess any changes in mood/behaviour from the start of the study. All the findings will be analysed in terms of relationship to RO7812653. Total time in the study will be about 8 to 11 months.
REC name
London - West London & GTAC Research Ethics Committee
REC reference
25/LO/0508
Date of REC Opinion
18 Nov 2025
REC opinion
Further Information Favourable Opinion