RecruitingPHASE1INTERVENTIONAL

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

This research study is investigating a new medication, RO7812653, for people in the early stages of Alzheimer's disease. The main goals are to understand if the medication is safe, how well people tolerate it, and how it works in the body. Participants will receive either the new medication or a placebo, which is an inactive substance, to help researchers compare their effects. This is a Phase 1 study, meaning it's one of the first times this new treatment is being tested in humans. The study is open to both men and women aged 50 to 75 who have been diagnosed with early Alzheimer's disease.

At a glance

Status

Recruiting

Phase

PHASE1

Sponsor

Hoffmann-La Roche

Enrolment target

Start

27 Jan 2026

Estimated completion

05 Mar 2030

Alzheimer's Disease

What is this study about?

This study is focused on a new investigational medication called RO7812653, which is being tested for people with early Alzheimer's disease. Many research studies like this are crucial steps in finding new ways to treat and understand conditions like Alzheimer's. The primary goals are to check if the new medication is safe to use in humans, how well people tolerate it (meaning if they experience any uncomfortable side effects), and how the body handles the medication once it's taken.

Researchers will also be looking at how this medication might affect biological processes in the body related to Alzheimer's disease. To make sure the results are clear, some participants will receive the active study medication, while others will receive a 'placebo'. A placebo looks just like the study medication but contains no active ingredients. This helps researchers determine if any changes observed are due to the medication itself or other factors.

This is a 'Phase 1' study, which means it's an early stage of human testing. These studies are essential to gather initial information about a new treatment before it can move into larger trials. Understanding how safe a new medication is and how it behaves in the body is the first step towards potentially making it available to patients in the future.

Key takeaways

This study is testing a new medication, RO7812653, for early Alzheimer's disease.
The main aims are to check safety, how well people tolerate it, and how it works in the body.
Participants will receive either the active medication or a placebo (dummy treatment).
It's a Phase 1 study, focusing on initial human testing.
Open to men and women aged 50-75 with early Alzheimer's diagnosis.

Who may be eligible?

To join this study, you must have a diagnosis of probable Alzheimer's dementia or a condition called Mild Cognitive Impairment (MCI) that is thought to be caused by Alzheimer's. You should be aged between 50 and 75 years old, and able to understand and complete study assessments, either on your own or with the help of a study partner. It’s also important that you can speak the language used for the tests and have good enough sight and hearing to take part.

There are also some reasons why you might not be able to join. These include having other medical conditions that could affect your brain or memory, or certain significant heart, lung, kidney, gut, or blood conditions that are not well-managed. You also can't have a history of serious mental health conditions like schizophrenia or bipolar disorder, or any brain abnormalities that would make certain study procedures unsafe.

Quick self-check

Are you between 50 and 75 years old?
Have you been diagnosed with early Alzheimer's disease or Mild Cognitive Impairment (MCI) likely due to Alzheimer's?
Can you understand and complete study tasks, possibly with help from a partner?
Do you have any other significant medical conditions (e.g., heart, lung, kidney problems) that are not well-controlled, or a history of serious mental health conditions?
Are you willing not to take part in other research studies while this one is ongoing?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you take part in this study, you would receive either the new study medication, RO7812653, or a placebo (a dummy treatment). The study involves regular visits to the clinic where you would undergo various assessments. These could include memory and thinking tests, blood tests, and possibly other procedures like a lumbar puncture (spinal tap) to collect fluid from around your brain and spine. You will receive clear instructions about how to take the medication, and your health will be closely monitored throughout the study. The total duration of your participation would be explained to you in detail by the study team, along with how many visits are expected and how long each might take.

Potential risks and benefits

Participating in a clinical trial may offer potential benefits, such as contributing to medical knowledge and potentially gaining access to a new experimental treatment before it's widely available. However, there are also potential risks, including side effects from the medication or discomfort from study procedures. All participants have the right to withdraw from the study at any time, for any reason, without it affecting their usual medical care.

Locations (8)

Brain Research Center Amsterdam
Amsterdam, Netherlands· Recruiting
Hospital Universitario Reina Sofia
Córdoba, Spain· Recruiting
Sahlgrenska Universitetssjukhuset
Mlndal, Sweden· Recruiting
Karolinska Universitetssjukhuset
Solna, Sweden· Recruiting
Institute of Psychiatry, Psychology and Neuroscience;Department of Old Age Psychiatry
London, United Kingdom· Recruiting
Southampton General Hospital
Southampton, United Kingdom· Recruiting
Queen Elizabeth Hospital
Glasgow, United Kingdom· Recruiting
National Hospital For Neurology and Neurosurgery
London, United Kingdom· Recruiting

Common questions

What is Alzheimer's disease?

Alzheimer's disease is a common type of dementia that causes problems with memory, thinking, and behaviour. Symptoms usually develop slowly and get worse over time.

What is a 'placebo'?

A placebo is an inactive substance that looks exactly like the study medication but contains no active drug. It helps researchers compare the effects of the new treatment.

What does 'early symptomatic Alzheimer's disease' mean?

This refers to the early stages of Alzheimer's disease, where symptoms like memory loss or thinking problems are noticeable but may not yet severely interfere with daily life.

Will I know if I'm getting the drug or the placebo?

Typically, in this type of study, neither you nor the study team will know whether you are receiving the active medication or the placebo. This is to ensure fair and unbiased results.

What is a Phase 1 study?

A Phase 1 study is one of the first steps in testing a new medication in humans. Its main purpose is to evaluate the safety and basic effects of the drug.

How to find out more

Reference Study ID Number: BP45770 https://forpatients.roche.com/

global-roche-genentech-trials@gene.com 888-662-6728 (U.S. and Canada) Official trial record

Always speak to your GP or specialist before deciding to take part in a study.