Table of Contents
- Trial overview
- Who is being studied
- What the trials measure
- Trial phases and status
- Trial-by-trial summary
Trial overview
The source data includes two authorised clinical trials investigating LY3372993 in Alzheimer’s disease research.[1][1] One study is in people with dominantly inherited Alzheimer’s disease (DIAD), and the other is in people with early Alzheimer’s disease.[1][1] These are interventional studies, which means participants receive a study treatment or a matching placebo so researchers can compare outcomes fairly.[1][1]
Who is being studied
One trial is designed for individuals at risk for or with early-onset Alzheimer’s disease caused by a genetic mutation.[1] This study focuses on DIAD, a rare family-linked form of Alzheimer’s disease.[1] The other trial includes people with Alzheimer’s disease in an early stage.[1]
In patient terms, these studies are not for all people with memory problems.[1][1] They are aimed at specific groups, such as people with a known disease-causing mutation or people already in an early stage of Alzheimer’s disease.[1][1]
What the trials measure
The DIAD study has two stages and focuses on biomarkers, which are measurable signs in the body that can show how the disease is changing.[1] In Stage 1, the study looks at early disease biomarkers such as amyloid PET, soluble amyloid, and soluble phospho-tau compared with baseline, which means the starting point before treatment.[1] In Stage 2, if used, the study looks at changes in biomarkers linked to tau, neurodegeneration, and inflammation over different periods of the presymptomatic phase, which is the stage before clear symptoms appear.[1]
The early Alzheimer’s disease trial uses a different main outcome.[1] Its primary endpoint is time to clinically meaningful progression, measured by the Clinical Dementia Rating (CDR), a clinician-rated scale that shows the person’s stage and level of impairment across early Alzheimer’s disease.[1] This means researchers are watching how long it takes before the disease clearly gets worse in a way that matters in daily life.[1]
Trial phases and status
The DIAD trial is a Phase 4 study with 301 planned participants and is listed as authorised.[1] Phase 4 studies are usually done after earlier testing and can help researchers learn more about outcomes in a specific group.[1]
The early Alzheimer’s disease trial is a Phase 3 study with 1,393 planned participants and is also listed as authorised.[1] Phase 3 studies are typically larger and are used to check how well a treatment works in a broader group of participants.[1]
Trial-by-trial summary
2024-517187-36-01 studies prevention of disease progression in people at risk for or with early-onset Alzheimer’s disease caused by a genetic mutation.[1] The trial compares study treatment with a placebo to match LY3372993 and measures changes in biomarkers, including brain amyloid measured by PiB PET and centiloid (CL), which is a way to express amyloid burden on a standard scale.[1] The study summary says the goal is to prevent or slow the rate of amyloid accumulation and to evaluate downstream biomarkers of Alzheimer’s disease.[1]
2024-515656-20-00 studies LY3372993 in early Alzheimer’s disease.[1] The main result being measured is the time to clinically meaningful progression by CDR, and the study compares treatment with a placebo to match LY.[1] This trial is focused on whether treatment can delay worsening in early disease.[1]
