Phase 1 Study of RO7812653 Given Into the Spine to Assess Safety and Effects in Adults Aged 50 to 75 With Early Symptomatic Alzheimers Disease

What this Trial Is About

Researchers are evaluating the safety, tolerability, immune response, and how the body processes and responds to the drug RO7812653 in people with early symptomatic Alzheimers Disease eAD. This Phase I trial compares RO7812653 to a placebo to understand its effects when given via spinal injection. The study is designed as a randomized, double-blind, placebo-controlled trial involving participants aged 50 to 75 years with early Alzheimers symptoms. Participants will be randomly assigned to receive either a single dose of RO7812653 or a placebo through intrathecal administration. The dosing follows a schedule outlined in the study protocol and is part of a parallel group design. The trial includes monitoring for drug presence in blood plasma and cerebrospinal fluid, as well as checking for antibodies against the drug. During the study, participants will undergo assessments to monitor safety, including tracking any adverse events and changes in suicide risk over about 40 weeks. Evaluations also include neuropsychological testing, imaging to assess brain conditions, and laboratory tests. Participants are expected to complete all assessments with or without the help of a study partner, and the study aims to gather detailed information on the drugs effects and safety over the study period.

A Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO7812653 in Participants With Early Symptomatic Alzheimer's Disease (eAD)