RecruitingPhase 1NCT07234942

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


Sponsor

Hoffmann-La Roche

Enrollment

50 participants

Start Date

Jan 27, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

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


Eligibility

Min Age: 50 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing the safety and how a new experimental drug called RO7812653 behaves in the body in people with early-stage Alzheimer's disease, including those with mild memory problems or mild dementia. **You may be eligible if...** - You have been diagnosed with early Alzheimer's disease, either mild cognitive impairment (MCI) or mild dementia due to Alzheimer's - You are able to complete study assessments, either on your own or with a study partner's help - You can see and hear well enough to complete thinking and memory tests (glasses and hearing aids are allowed) - You can read and communicate in the language used at the study site **You may NOT be eligible if...** - Your memory or thinking problems are due to another cause - You have significant other health conditions that make participation unsafe Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGRO7812653

Participants will receive RO7812653 as per the schedule in the protocol

DRUGPlacebo

Participants will receive placebo as per the schedule in the protocol


Locations(6)

Brain Research Center Amsterdam

Amsterdam, North Holland, Netherlands

Sahlgrenska Universitetssjukhuset

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

National Hospital For Neurology and Neurosurgery

London, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT07234942


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