Dementia Support Line
Study of RO7812653 for early symptomatic Alzheimer's disease
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Use the information below to reference this clinical trial when speaking with your healthcare professional or research team.
Note: the information presented on the Clinical Trial Finder is for information only. To join a clinical trial you must meet the eligibility criteria set by the study and the research team will discuss this with you.
This trial is open to recruitment at the following locations. Contact your preferred location at their email address.
Contact the Clinical Trials team
- National Hospital for Neurology and Neurosurgery (UCLH), London: [email protected]
- Queen Elizabeth University Hospital, Glasgow: coming soon
- Royal Hallamshire Hospital, Sheffield: coming soon
- University Hospital Southampton: [email protected]
This study is testing a new investigational medicine called RO7812653.
The aim of this study is to compare RO7812653 with a placebo (a dummy medicine) to see:
- How well RO7812653 works
- How safe RO7812653 is in people who have early signs of Alzheimer’s disease.
RO7812653 is an experimental medicine. This means health authorities (like the U.S. Food and Drug Administration and European Medicines Agency) have not approved RO7812653 for the treatment of AD.
How the study is carried out
This study is a double-blind placebo-controlled trial. This means:
- Some people will get RO7812653.
- Some people will get a placebo (a dummy treatment that has no medicine in it).
Neither the participant, their study doctor, nor the study team will know who is getting which treatment during the first part of the study. This helps make the results fair.
People in the study will be put into their treatment groups by chance, like flipping a coin. Most participants will have a 3 in 4 chance of receiving RO7812653 (the study drug) and a 1 in 4 chance of receiving a placebo (a dummy treatment).
For the very first group taking part, the chances are slightly different: they will have a 2 in 3 chance of getting the study drug and a 1 in 3 chance of getting a placebo.
Find more information about why studies use blinding, randomisation and placebo controls.
How is the study treatment given?
RO7812653 or placebo is given as an injection into the space around the spine so it can reach the brain more directly. Participants will be given RO7812653 or placebo once in the study.
What will participants be asked to do during the study?
During the study, participants will:
- Have some laboratory tests, such as blood tests. These tests help doctors check for any new side effects, such as symptoms or health changes that might happen after receiving the study medicine.
- Have brain scans called magnetic resonance imaging (MRI) scans. These scans take detailed pictures of the brain to help doctors check brain health and safety.
- Wear a heart monitor that records your heartbeat so doctors can spot any problems that a quick heart test might miss, like your heart beating too fast, too slow, or feeling like it skips a beat.
- Be admitted to hospital to be monitored immediately before, and for 24 hours after receiving RO7812653 or placebo
- Complete tests that look at memory, thinking, and emotional wellbeing.
If participants would like more details about the tests, procedures, or number of visits, the study team can provide full information.
Who can take part
- People who have been diagnosed with early symptomatic Alzheimer’s disease or Mild Cognitive Impairment (MCI) due to Alzheimer’s disease.
- People who are not on any medication for the symptoms of their Alzheimer’s disease, or, who have been on a stable dose of medication for the symptoms of their Alzheimer’s disease for at least 8 weeks prior to screening and until randomization.
- People who are able and willing to meet all study requirements in the opinion of the Investigator
- To take part in this study you must have a study partner (a close friend or family member who has regular contact with you and can provide information at study visits).
Who cannot take part
- People who are pregnant or breastfeeding
- People who have a history of schizophrenia, schizoaffective disorder, major depression or bipolar disorder
- People who have any current or previous medical conditions which would make spinal injections dangerous for them
- People who have any medical conditions which in the opinion of the study doctor are unstable or inadequately controlled.
Other specific medical criteria will apply, which a study doctor will discuss with you and evaluate.
Clinical trial team
Who can take part
- People who have been diagnosed with early symptomatic Alzheimer’s disease or Mild Cognitive Impairment (MCI) due to Alzheimer’s disease.
- People who are not on any medication for the symptoms of their Alzheimer’s disease, or, who have been on a stable dose of medication for the symptoms of their Alzheimer’s disease for at least 8 weeks prior to screening and until randomization.
- People who are able and willing to meet all study requirements in the opinion of the Investigator
- To take part in this study you must have a study partner (a close friend or family member who has regular contact with you and can provide information at study visits).
Who cannot take part
- People who are pregnant or breastfeeding
- People who have a history of schizophrenia, schizoaffective disorder, major depression or bipolar disorder
- People who have any current or previous medical conditions which would make spinal injections dangerous for them
- People who have any medical conditions which in the opinion of the study doctor are unstable or inadequately controlled.
Other specific medical criteria will apply, which a study doctor will discuss with you and evaluate.