This study is designed to evaluate new approaches to Alzheimer’s treatment, aiming to reduce key proteins, amyloid and tau, that build-up in the brain in early Alzheimer’s disease.
The first tau-targeting therapy being studied is called AADvac1, which is designed to target tau. Researchers will evaluate how well it works by itself, and in combination with donanemab, a drug that targets amyloid. They will compare these results to treatment with donanemab alone.
The study population includes adults ages 50–80 years old with no symptoms or only very mild symptoms of Alzheimer’s disease. Even though those individuals do not have noticeable symptoms, testing shows that they already have amyloid and tau changes in the brain, based on blood tests and brain imaging.
The study uses a randomized design, meaning that treatment is assigned by chance to one of three groups:
- Donanemab alone (to remove amyloid)
- Donanemab plus AADvac1 (to remove amyloid and target tau)
- AADvac1 alone (to target tau without removing amyloid)
Study treatment is given under blinded conditions for about 30 months, meaning that neither participants nor study teams know which treatment group is assigned during the study.
The main goal of the study is to understand whether combining treatments that target amyloid and tau works better than targeting just one of the proteins, especially in people at the earliest stages of disease.
The study is also designed to be flexible. As new tau-targeting treatments become available, they may be added to the study with plans to test additional tau therapies in the future.