RecruitingPhase IInterventional

First-in-human study of RO7812653

This study is investigating a new, experimental medicine called RO7812653 for people with early Alzheimer’s disease. It's a Phase 1 study, meaning the main goals are to check how safe the medicine is at different doses and how the body handles it. Participants will be randomly assigned to receive either RO7812653 or a placebo (a dummy treatment) as an injection into the lower back, around the spinal cord. Neither you nor the study team will know which you are receiving until the study ends. We're looking for men and women aged 50-75 with early Alzheimer's. This research could help us learn more about treating the disease in the future, even if it doesn't directly benefit you.

At a glance

Status

Recruiting

Phase

Phase I

Sponsor

F. Hoffmann-La Roche AG

Enrolment target

Start

28 Nov 2025

Estimated completion

31 Aug 2027

Early symptomatic Alzheimer’s disease (eAD)

What is this study about?

This research is looking into a new medicine called RO7812653 for people living with early Alzheimer's disease. Alzheimer's is a condition that affects memory and thinking. This particular medicine is still in its early stages of testing, which means it hasn't been approved by health authorities yet. We need to study it carefully to understand how it works and whether it might be a helpful new treatment option in the future.

The main aims of this study are to find out if RO7812653 is safe for people to take, and to explore how the body absorbs, uses, and gets rid of the medicine. This is a crucial step in developing any new treatment, as safety is always the top priority. We'll also be giving different doses of the medicine to see what effects they have.

By taking part in this study, you would be contributing to important medical research. Even if this medicine doesn't directly make you feel better, the information we gather could be incredibly valuable in helping future patients with Alzheimer's disease. We want to learn as much as possible to improve our understanding and treatment of this condition.

Key takeaways

This study is testing a new medicine for early Alzheimer's disease.
It aims to check the medicine's safety and how it works in the body.
Treatment is given as an injection into the lower back.
You might receive the medicine or a dummy treatment (placebo).
It's an early-stage study, so direct benefits are not guaranteed.
You can leave the study at any time if you wish.

Who may be eligible?

This study is looking for men and women between 50 and 75 years old who have been diagnosed with early Alzheimer's disease. This includes people with a likely diagnosis of Alzheimer's dementia or mild memory problems due to Alzheimer's.

You might not be able to join if your memory or thinking problems are caused by another condition, such as Parkinson's disease or a different type of dementia. Also, if you have any brain problems that would make a spinal injection unsafe, you won't be able to take part. This includes certain changes seen on a brain scan.

Pregnant or breastfeeding women cannot participate. Your study doctor will check all your health details to make sure this study is right and safe for you.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you between 50 and 75 years old?
Have you been diagnosed with early Alzheimer's disease, including mild memory problems due to Alzheimer's?
Are your memory problems NOT caused by another condition like Parkinson's or a different type of dementia?
Do you not have any brain conditions that would make a spinal injection unsafe?
If you are a woman, are you not pregnant or breastfeeding?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll first go through a screening period, which starts about two months before any treatment begins. This is to check if you meet all the study requirements. Once you're in the study, you'll be randomly assigned to one of two groups: either you'll receive the new medicine, RO7812653, or a placebo. A placebo looks exactly like the medicine but contains no active ingredients. This helps researchers understand if the medicine is truly having an effect.

The study treatment, whether it's the medicine or the placebo, will be given as an injection into the lower back, directly into the fluid around your spinal cord. You have a 1 in 4 chance of being in the placebo group (this might be 1 in 3 for the very first group of participants). Neither you nor the study staff will know which treatment you are receiving until the study is finished, but your doctor can find out if it's important for your safety.

The total study will last for a few months. During this time, you'll have regular visits with the study doctor to monitor your health, see how you're responding to treatment, and check for any side effects. You will also have follow-up visits after your treatment has finished to ensure your wellbeing. Remember, you are free to leave the study at any time.

Potential risks and benefits

It's important to know that while taking part might not directly make you feel better, the information collected could greatly help others with Alzheimer's disease in the future. As this is a new medicine, we don't fully know all its potential effects. There are some risks, generally not higher than those in standard medical care or from Alzheimer's disease itself. You will be fully informed about all known and potential risks before you agree to participate. Possible side effects from the injection into the lower back can include headaches, back pain, or temporary numbness in the legs. Even though the new medicine RO7812653 is designed to be safer, similar types of medicines have, in the past, shown side effects like increased pressure in the head, or issues with kidneys, liver, or blood. We will monitor you closely for any unwanted effects throughout the study, which can range from mild to severe. It’s also crucial that if you are a woman who could become pregnant, or a man whose partner could become pregnant, you take precautions to avoid pregnancy during the study, as the medicine may be harmful to an unborn baby. You have the right to withdraw from the study at any time.

Locations (5)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

University College London Hospitals NHS Foundation Trust
City only
London, England
South London and Maudsley NHS Foundation Trust
City only
Beckenham, England
University Hospital Southampton NHS Foundation Trust
City only
Southampton, England
Sheffield Teaching Hospitals NHS Foundation Trust
City only
Sheffield, England
NHS Greater Glasgow and Clyde
City only
Glasgow, Scotland

Common questions

What is RO7812653?

It's a new, experimental medicine being tested to see if it can help treat early Alzheimer's disease. It's not yet approved by health authorities.

How will I receive the treatment?

The medicine or a dummy treatment (placebo) will be given as an injection into your lower back, into the fluid around your spinal cord.

Will I know if I'm getting the actual medicine or the placebo?

No, neither you nor the study team will know which treatment you are receiving until the study ends. This is done to keep the results fair.

What if I change my mind during the study?

You can decide to stop the study and withdraw at any time, for any reason. Your health and wellbeing are the priority.

Who is paying for this research?

The study is funded by F. Hoffmann-La Roche AG, a pharmaceutical company based in Switzerland.

How to find out more

Clinical Trials

global.trial_information@roche.com +41 (0)616878333 Official trial record

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