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RecruitingNCT07234942

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

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

Status
Recruiting
Phase
Phase 1
Study type
Interventional
Enrollment
50 (estimated)
Sponsor
Hoffmann-La Roche · Industry
Sex
All
Age
50 Years – 75 Years
Healthy volunteers
Not accepted

Summary

This study aims to evaluate the safety, tolerability, immunogenicity, pharmacokinetics, and pharmacodynamics following administration of RO7812653 in participants with eAD.

Conditions

Interventions

TypeNameDescription
DRUGRO7812653Participants will receive RO7812653 as per the schedule in the protocol
DRUGPlaceboParticipants will receive placebo as per the schedule in the protocol

Timeline

Start date
2026-01-27
Primary completion
2028-04-19
Completion
2030-03-05
First posted
2025-11-19
Last updated
2026-04-03

Locations

5 sites across 3 countries: Netherlands, Sweden, United Kingdom

Source: ClinicalTrials.gov record NCT07234942. Inclusion in this directory is not an endorsement.

A Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO7812653 in Participants Wit (NCT07234942) · Clinical Trials Directory