CVHB937A12201
Research type
Research Study
Full title
A randomized, placebo-controlled, parallel group, 72-week study to evaluate the efficacy and safety of VHB937 in participants with early Alzheimer’s Disease followed by an Extension
IRAS ID
1011845
Contact name
Carmen Rezola
Contact email
Sponsor organisation
Novartis Pharma AG
Research summary
Alzheimer’s Disease (AD) is a progressive neurodegenerative disorder and the most common cause of dementia. It leads to memory loss, cognitive decline, and an inability to perform daily activities.
VHB937 is an investigational antibody designed to activate microglia, a type of brain cell that protects neurons. By modulating microglial function, VHB937 may help slow or prevent further nerve cell damage, offering a potential new treatment approach for AD.
This study aims to evaluate the safety and effectiveness of VHB937 compared with a placebo in people with early AD. It will determine whether VHB937 can help slow the progression of AD symptoms.
The study will enroll approximately 407 participants, aged 50–85, with confirmed early AD. It will be conducted in approximately 15 countries including the UK.
The study is divided into 4 periods:
• Screening period (approx. 2 months): To assess if participants are eligible to take part in the study
• Double-blind period (approx. 1 year and 6 months): Participants will be assigned to one of the following study treatments by chance:
o VHB937: active investigational treatment
o Placebo: it looks like VHB937 but has no active treatment in it. Using a placebo helps researchers better understand the actual effects of the active treatment under investigation.
• Treatment Extension: If eligible, participants may receive VHB937. Those initially on placebo will also receive VHB937.
• Follow-up: After the last treatment, participants will have two follow-up visits for health monitoring.
There might be aspects associated with VHB937 treatment that are not yet known or have not been predicted. Participants will be closely monitored by the trial doctors for any such medical problems that may happen during the trial.REC name
London - Surrey Borders Research Ethics Committee
REC reference
25/LO/0398
Date of REC Opinion
26 Jun 2025
REC opinion
Further Information Favourable Opinion