Active not recruitingPHASE2INTERVENTIONAL

A Study to Evaluate the Safety and Biomarker Effects of RO7269162 in Participants at Risk for or at the Prodromal Stage of Alzheimer's Disease (AD)

Researchers are looking for people aged 60 to 85 years old to join a study about Alzheimer's disease. This includes individuals who might be at an early stage of the disease, perhaps just starting to experience very mild memory issues, or those who are at risk but don't yet have symptoms. The study aims to find out if a new potential medicine, called RO7269162, is safe and how it might affect the body. Some participants will receive the new medicine, while others will get a placebo (a dummy treatment). Over about 90 weeks, participants will have regular check-ups, especially in the first few months, so the study team can monitor their health and any effects of the treatment.

At a glance

Status

Active not recruiting

Phase

PHASE2

Sponsor

Hoffmann-La Roche

Enrolment target

256

Start

02 May 2024

Estimated completion

19 Nov 2026

Alzheimer's Disease

What is this study about?

This research study is looking into a new potential medicine called RO7269162. It's designed for people who are either at risk of developing Alzheimer's disease or are in the very early stages, where memory problems are mild. Scientists believe that a substance called beta-amyloid builds up in the brain years before Alzheimer's symptoms are clear. This study is recruiting people who have this build-up in their brain, even if they don't have obvious memory issues yet, or if they have mild memory problems that doctors think are due to early Alzheimer's.

The main goal is to understand if RO7269162 is safe for people to take and to see if it has any effects on the body that could be important for Alzheimer's. This is an early-stage study (Phase 2), meaning it's exploring safety and initial effects rather than being a large study to prove the medicine works to stop or slow the disease.

Taking part in studies like this is really important. It helps doctors and scientists learn more about diseases like Alzheimer's and develop new treatments in the future. Your involvement could contribute to worldwide understanding and potentially help many other people in the long run.

Key takeaways

This study is for people aged 60-85 at risk for or with very early signs of Alzheimer's disease.
It tests a new medicine (RO7269162) for safety and its effects, compared to a placebo.
Participants need signs of amyloid build-up in the brain, confirmed by a special scan.
A 'study partner' will help provide information about your daily life and memory.
Participation involves regular hospital visits over roughly 90 weeks to monitor health and treatment.
You won't know if you're getting the active medicine or the placebo until after the study is complete.

Who may be eligible?

This study is designed for men and women aged between 60 and 85 years old. You might be able to take part if you have a certain amount of a substance called amyloid built up in your brain, which will be checked with a special brain scan. This could be the case if you don't yet have any memory problems but are at risk, or if you have very mild memory changes that doctors think are due to early Alzheimer's.

It's important that you are generally healthy otherwise. For example, your body weight needs to be within a certain range, and you shouldn't have serious heart, kidney, or liver problems. Also, if you're taking any medicines for Alzheimer's already, your dose needs to have been stable for at least eight weeks.

Because the study needs to understand how you are doing, you'll need to have a 'study partner' – someone who knows you well and can provide information about your memory and daily activities. This person usually has regular contact with you, understands you well, and can commit to helping with the study. They don't have to be a family member.

Quick self-check

Are you between 60 and 85 years old?
Do you have very mild memory changes, or are you at risk of Alzheimer's but don't have symptoms yet?
Do you have a 'study partner' who can support you and provide information?
Are you generally healthy, without major heart, kidney, or liver conditions?
Is your body weight within a healthy range (BMI between 18 and 35)?
If you take Alzheimer's medicines, has your dose been steady for at least 8 weeks?

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

What does participation involve?

If you decide to join this study, your involvement will last for about 90 weeks, which is roughly a year and three-quarters. You will receive either the new study medicine, RO7269162, or a placebo (a dummy treatment that looks like the real thing but has no active medicine) for up to 18 months.

In the first three months, you'll have appointments with the study team at the hospital every three weeks. After that, your visits will be every six weeks until the end of the study. During these visits, the study team will carefully check how you are responding to the treatment and look for any possible side effects. They will also carry out assessments to monitor your health and any changes you might experience.

Potential risks and benefits

Taking part in any study has potential benefits and risks. You might not directly benefit from taking part, as you could receive the placebo. However, you would be helping researchers learn more about Alzheimer's disease and possibly develop future treatments. There's a chance you might experience side effects from the study medicine; these will be closely monitored by the study team. You have the right to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (46)

Centro de Investigación Clínica UC-CICUC
Santiago, Chile
Hospital Clinico Univ de Chile
Santiago, Chile
Aarhus Universitetshospital Skejby
Aarhus N, Denmark
Rigshospitalet, Hukommelsesklinikken
Koebenhavn Oe, Denmark
Groupement Hospitalier Est - Hôpital Neurologique
Bron, France
Hopital B Roger Salengro
Lille, France
Hôpital de la Timone
Marseille, France
Hôpital Lariboisière
Paris, France
CHU de Rouen Hopital
Rouen, France
Hop Guillaume Et Rene Laennec
Saint-Herblain, France
Hôpital Robertsau
Strasbourg, France
Gerontopole
Toulouse, France

+34 more sites — see the official record for the full list.

Common questions

What is RO7269162?

It's a new potential medicine being tested in this study to see if it's safe and how it affects the body in people at risk of or with very early Alzheimer's disease.

What is a 'placebo'?

A placebo is a dummy treatment. It looks just like the study medicine but doesn't contain any active ingredients. This helps researchers compare the effects of the actual medicine fairly.

What is a 'study partner'?

A study partner is someone who knows you well, spends time with you, and can provide information to the study team about your daily activities and memory. They help the researchers understand how you're doing.

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

No, neither you nor the study team will know whether you are receiving the active medicine or the placebo during the study. This is to ensure the results are accurate and unbiased.

How long will I be in the study?

Your participation in the study will last for about 90 weeks, which is approximately one year and nine months.