In short
Clinical trials are studying VHB937 in people with amyotrophic lateral sclerosis (ALS) and Alzheimer’s disease. These Phase 2 studies aim to compare VHB937 with placebo and measure outcomes such as function, survival, and cognition in adults with these conditions.
Key points
- Clinical trials are studying VHB937 in two different diseases: amyotrophic lateral sclerosis (ALS) and Alzheimer’s disease. Both studies are Phase 2 and are authorised. The ALS trial plans to compare VHB937 with placebo in 225 people and looks at a combined measure of function and survival. The Alzheimer’s disease trial plans to enroll 407 people and measures change in the Clinical Dementia Rating scale – Sum of Boxes. These trials are designed to see whether VHB937 may help with disease outcomes in these patient groups.
Trial overview
Two interventional studies are investigating VHB937, which means researchers are giving a study treatment and comparing the results with another group. Both trials are in Phase 2, and both are authorised.
One study is in people with amyotrophic lateral sclerosis (ALS), and the other is in people with Alzheimer’s disease. These trials are designed to learn whether VHB937 may improve disease-related outcomes compared with placebo.
ALS study details
The ALS trial is titled “A clinical trial to learn about the effects of VHB937 in people with amyotrophic lateral sclerosis (ALS).” It plans to enroll 225 people and is authorised.
This study compares VHB937 with placebo, which is a study infusion that does not contain the active trial drug and is used for fair comparison. The brief summary says the goal is to compare the efficacy of VHB937 versus placebo on a composite of permanent assisted ventilation (PAV)-free survival and function in the double-blind period.
The main outcome is the composite of PAV-free survival and change in ALSFRS-R, analysed using Combined Assessment of Function and Survival (CAFS) from baseline to double-blind week 40. In simple terms, this means the study looks at both breathing-related survival and daily function together, not just one result alone.
Alzheimer’s disease study details
The Alzheimer’s disease trial is titled “A clinical trial to learn about the effects of VHB937 in people with Alzheimer's disease.” It is also authorised and plans to enroll 407 people.
This study compares VHB937 with placebo and is focused on cognition and function, meaning memory, thinking, and daily life abilities. The trial uses an infusion form of the study treatment, as listed in the trial data.
The primary outcome is the change from baseline to week 72 in the Clinical Dementia Rating scale – Sum of Boxes (CDR-SB). This score helps researchers measure how Alzheimer’s disease changes thinking and daily function over time.
What the trials measure
The ALS study focuses on a combined outcome, which is a way of putting two important results together: survival without permanent assisted ventilation and change in ALSFRS-R. This helps researchers see whether treatment affects both life support needs and everyday function.
The Alzheimer’s disease study measures change in CDR-SB from baseline to week 72. This is a standard way to track how much the disease affects memory, thinking, and daily activities over time.
Who can participate
Each trial is limited to one disease group: people with ALS for the first study and people with Alzheimer’s disease for the second study. The trial data do not list the full eligibility rules, so the exact participation criteria are not shown here.
Because these are disease-specific studies, a person would need to have the condition being studied and meet the study’s detailed requirements.
How the studies are designed
Both studies are Phase 2 and interventional, which means they are testing a treatment in people and looking closely at whether it may help. The ALS study includes a double-blind period, meaning the people in the study and the researchers do not know who is receiving VHB937 or placebo during that time.
The trial records provide the main condition, phase, status, planned enrollment, intervention type, and primary outcome for each study. They do not give detailed results yet, so these records describe ongoing research rather than final findings.