A clinical trial to look at how well RO7269162 works in people who are at risk of Alzheimer’s disease or who have mild cognitive impairment due to Alzheimer’s disease and how safe RO7269162 is at different doses
Information about the drug that will be tested in the study
Administration
Pill - Oral administration daily
Is the drug already on the market for another medical condition?
No
Will all participants receive the same drug?
Participants will be selected by chance to receive one of the following options:
- Pill(s) of RO7269162 (one of three dose levels)
- Pill(s) of placebo (also called a dummy treatment which is an inactive substance identical in appearance to the drug being tested with no active therapeutic effect).
Neither the participant nor their doctor will know if the person is receiving the investigational drug or the placebo.
Information about participating in the trial
What are the researchers trying to find out?
The purpose of the study is to evaluate the safety, tolerability and efficacy of RO7269162 in people at risk for or at the prodromal stage of Alzheimer's disease.
How long will the treatment last?
- Around 1.5 years
What your involvement will entail?
- During the study, participants will be asked to complete a PET brain scan and CSF examination (lumbar puncture)
- Complete some laboratory tests such as blood tests to evaluate the emergent adverse events (unfavourable signs, symptoms or diseases temporally associated with the use of the drug tested in the study).
The clinical trial team will see participants every 3 weeks in the first 3 months and then every 6 weeks until the end of the trial. These hospital visits will include checks to see how the participant responds to the treatment and any side effects they may have. Further information on the procedures, tests and number of visits can be obtained from the study team.
Who can participate in this study?
Who can participate in the study?
To take part in the study, participants must:
- Be between 60 and 85 years old
- Have a body mass index between 18 to 35 kg/m²
- Be cognitively unimpaired or have a diagnosis of mild cognitive impairment due to Alzheimer’s disease according to the National Institute on Aging - Alzheimer's Association (NIA - AA) research criteria
- Have a score of 5 or 0.5 in the Clinical Dementia Rating-Global Score (CDR-GS)
- Have build-up of beta-amyloid (according to positive amyloid PET scan)
- Have a study partner who has a sufficient contact with the participant, is willing to participate in study procedures throughout the study duration and agree to provide information about the participant’s ability to think, communicate and perform daily activities
- If the person is taking approved symptomatic medication for dementia (i.e. donepezil, rivastigmine or galantamine), the dosing regimen must have been stable for at least 8 weeks before the start of the study.
Who cannot participate in the study?
People cannot take part in the study if they have or have experienced:
- A disease or condition that may interfere with the safety and/or study assessments or could be the cause of cognitive impairment (e.g., major psychiatric disorder, systematic vascular disease, intracranial mass)
- History or presence of significant cardiovascular conditions, significant haematological disease, chronic kidney disease or impaired hepatic function
- Uncontrolled/poorly controlled diabetes
- Pregnancy or breastfeeding.
The above list is not exhaustive. It includes the most common conditions and diseases that might exclude people from the study.
Information for your doctor
EU Clinical Trial Number
2023-506183-13-00
Clinicaltrials.gov identifier
NCT06402838
Study contact information
global-roche-genentech-trials@gene.com
Link to full text
https://www.clinicaltrials.gov/study/NCT06402838
Link to sponsor's website
The information contained in this document is based on information available on public registries (e.g. clinicaltrials.gov website) on June 2024.
This document has been reviewed by the pharmaceutical company running this trial.
This document has been reviewed by a member of the European Dementia Carers Working Group.
