Table of Contents
- Clinical trial overview
- Who the study is for
- How the trial is designed
- What the trial is measuring
- Key study details
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.[1]
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.[1]
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.[1]
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.[1]
How the trial is designed
The study is a double-blind, randomized, placebo-controlled trial.[1]
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.[1]
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.[1]
What the trial is measuring
The main outcome is the change from baseline to Week 80 in the iADRS score.[1]
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.[1]
This outcome is meant to show whether the study treatment slows decline over time compared with placebo.[1]
Key study details
The trial ID is NCT06335173, and its phase is Phase 2.[1]
The condition studied is early Alzheimer’s disease, including mild cognitive impairment and mild dementia due to Alzheimer’s disease.[1]
The study status is authorised, and the planned enrollment is 630 people.[1]
