A screening study to identify people who may be able to take part in Alzheimer's disease studies

1. Why is this study needed?

This is a study to identify people who may be able to take part in Roche clinical studies of new medicines for Alzheimer’s disease (AD).

AD is a type of dementia that affects memory, thinking and behaviour. Symptoms usually develop slowly and get worse over time, becoming severe enough to interfere with daily tasks. AD is thought to be caused by changes in two proteins in the brain: amyloid and tau. Plaques (build-up of amyloid) and tangles (twisted threads of tau) are the main reasons that nerve cells are damaged in AD. In the earliest stage, called preclinical AD, people do not have problems with their memory or thinking yet, but already have plaques and may have tangles in the brain.

No medicine is being given in this study. Instead, participants will provide a blood sample to see how likely they are to have the amyloid protein in their brain. Participants will also perform a short memory test.

This study aims to identify people who may be eligible to take part in Roche AD clinical studies based on markers in the blood and their memory function.

2. Who can take part in the study?

Generally, people of 50 to 90 years of age can take part in the study, but exact age requirements depend on which Roche AD clinical studies are enrolling at the time. People must also be willing to receive information about whether they might qualify for a related Roche AD clinical study.

People may not be able to take part in this study if they have other brain conditions that affect thinking and memory, or a history of certain mental health conditions, such as schizophrenia or bipolar disorder.

3. How does this study work?

People will be checked to see if they are able to participate in the study; this process may take up to 3 weeks.

Everyone who joins this study will be asked some questions about themselves, asked to perform a memory test and have a blood draw. A blood draw, also known as a blood sample or blood collection, is the process of taking a small amount of blood from a person, usually from a vein in the arm. Doctors will look for pTau217 – a blood biomarker, to help identify people who are likely to have amyloid protein in their brain. A biomarker is a measurable indicator or sign that can be found in blood that can indicate a health condition. An experimental test will be used to measure the pTau217 biomarker in blood. It may take up to 2 weeks before the results of the blood draw are available. There will be 1 or 2 additional visits to discuss the results. Based on those results, participants may be invited to be screened to take part in a Roche AD study.

Participants have the right to leave the study at any time, if they wish to do so.

4. What are the main results measured in this study?

The main goal in the study is to identify people who may be able to participate in open Roche AD clinical studies. This will include measuring participants’:

• Level of pTau217 in the blood
• Score in a memory test known as the International Shopping List Test (ISLT)

Researchers will also collect basic information, such as age, sex, race or ethnicity, medical history, current medications, and living or social factors (if available).

5. Are there any risks or benefits in taking part in this study?

Risks associated with the study
Participants may have unwanted effects of the blood draw used in this study. Known unwanted effects include discomfort or pain, bruising, or infection where the needle is inserted.

Discussion of eligibility status (meaning whether a participant is recommended to screen for a related AD study based on their biomarker and memory test results) may cause emotional distress or anxiety in some participants.