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What is the aim of the study?

This study is testing a new medicine called ALN 5288 for people with Alzheimer’s disease. ALN 5288 is a treatment that helps the body make less of a protein called tau. Too much tau in the brain can cause it to clump together, which may lead to memory and thinking problems.

The medicine works by finding and breaking down the instructions inside cells that tell the body to make tau. By reducing tau production, the aim is to lower tau levels, and so slow down the changes in the brain caused by Alzheimer’s disease. The medicine is given as an injection into the space around the spine so it can reach the brain more directly.

What the study wants to find out

The study has two main goals:

• To check if ALN 5288 is safe for people with Alzheimer’s disease and to see how well people can tolerate it.
• To learn how the medicine works inside the body, including what it does and how the body uses and clears it after it is given.

How the study is carried out

This study is a double-blind placebo-controlled trial. This means:

• Some people will get ALN 5288.
• 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.

In the second part of the study, everyone will get ALN 5288, no matter what they received at the start. This part is called an open label extension, because everyone and their doctors will know they are getting the real medicine.

Find more information about why studies use blinding, randomisation and placebo controls.