About the Radiant Study

What is the Radiant Study?

Alzheimer’s disease (AD) affects memory, ability to think, and social skills. People with AD may also have psychosis. This is called Alzheimer’s disease psychosis (ADP). It involves hallucinations and delusions. Hallucinations include hearing or seeing things that others do not. Delusions include believing things that are not true. A person with ADP may have thoughts that:

people are plotting against them
their possessions are being stolen
images on the television are real
the person in the mirror is someone else.

The Radiant Study is looking at a potential new drug (study drug) to see how effective and safe it is at reducing delusions and hallucinations associated with ADP.

People taking part in this study must have a designated care partner who can attend all study center visits with them.

About 1000 people from around the world will take part in the Radiant Study. The study will compare the effects of the study drug to a placebo. A placebo looks like the study drug but contains no active medicine. A placebo helps to see if any effects of the study drug are due to people’s expectations of whether it may work or not. The placebo and study drug together are called the study medication.

People taking part in this study will be randomly assigned to 1 of 3 groups:

2 groups will receive the study drug
1 group will receive placebo.

You have an equal chance of being in any group.

At the end of the study, you may be able to take part in what is known as an open-label extension (OLE) study. In the OLE study, everyone will receive the study drug.

What to expect

The Radiant Study will last for about 4 months. People taking part in the study will need to visit the study center about 6 times. There will also be times when the person in the study or their care partner will need to speak by phone to the study team.

People in the study will have several tests and assessments performed to monitor their health. These will include:

Questionnaires and interviews about how they feel, how they are sleeping, and how AD affects their daily life
Physical and neurological examinations
Measurements of vital signs (for example: blood pressure, heart rate, breathing rate, and temperature)
Urine and blood samples

The study periods

The Radiant Study has a screening period, a study treatment period, and a follow-up period.

1

Screening period

(about 6 weeks)

The person interested in taking part and their care partner will visit the study center to see if the study is a good match and to decide if they want to join.

2

Study treatment period

(about 6 weeks)

There will be about 5 study center visits for study assessments.
The participant will take the study medication (a capsule) by mouth 1 time a day.

3

Follow-up period

After the study treatment period, the participant will:

enter the follow-up period of about 4 weeks and will have about 2 phone calls, or
consider joining an open-label extension (OLE) study to look at the effects of the study drug over a longer time period.