In short
Clinical trials are investigating Sabirnetug in people with early Alzheimer’s disease, including mild cognitive impairment and mild dementia due to Alzheimer’s disease. These studies are checking whether Sabirnetug can slow decline and whether it is safe and effective in this patient group.
Key points
- Sabirnetug is being studied in a Phase 2 trial for early Alzheimer’s disease, including mild cognitive impairment and mild dementia due to Alzheimer’s disease. The study is authorised and plans to enroll 630 people. It is a double-blind, randomized, placebo-controlled trial, which means the treatment is compared with placebo without participants or the study team knowing who gets which group. The main goal is to see whether Sabirnetug can slow cognitive and functional decline. The main measure is the change in iADRS score from the start of the study to Week 80.
Clinical trial overview
The available study is a Phase 2 trial of Sabirnetug in people with early Alzheimer’s disease, which includes mild cognitive impairment and mild dementia due to Alzheimer’s disease.
The study is authorised and is designed to evaluate both efficacy and safety, with the main focus on whether Sabirnetug can slow cognitive and functional decline compared with placebo.
Who the study is for
This trial is for adults with early Alzheimer’s disease, including the stages described as mild cognitive impairment and mild dementia due to Alzheimer’s disease.
These are early stages of the disease, when thinking problems are present and daily function may start to be affected, but the condition is not yet at a more advanced stage.
How the trial is designed
The study is a double-blind, randomized, placebo-controlled trial.
Randomized means people are assigned by chance to a study group, and double-blind means neither the participant nor the study team knows who receives Sabirnetug or placebo.
The study plans to enroll 630 participants and is listed as a study of intravenous Sabirnetug given every 4 weeks, based on the trial summary.
What the trial is measuring
The main outcome is the change from baseline to Week 80 in the iADRS score.
Baseline means the starting point before treatment begins, and the iADRS is a scale used to measure thinking and daily function in Alzheimer’s disease.
This outcome is meant to show whether the study treatment slows decline over time compared with placebo.
Key study details
The trial ID is NCT06335173, and its phase is Phase 2.
The condition studied is early Alzheimer’s disease, including mild cognitive impairment and mild dementia due to Alzheimer’s disease.
The study status is authorised, and the planned enrollment is 630 people.