NCT07094516

A Clinical Trial to Learn About the Effects of VHB937 in People With Early Alzheimer's Disease

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 407 (estimated)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 50 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

This is a multicentre, randomized, double-blind, placebo-controlled, parallel group Phase II study to evaluate the efficacy and safety of VHB937 in participants with early AD followed by an Extension. The double-blind part is 72 weeks long, followed by an extension.

Detailed description

The purpose of this study is to find out whether treatment with VHB937 is safe and beneficial in people with early Alzheimer's disease. The study will evaluate the safety of VHB937, as well as its effects on memory and other thinking abilities, on daily activities, and on changes in the brain. The study will also observe and measure how VHB937 is processed by the body and how the body responds to it.

Conditions

• Alzheimer's Disease

Interventions

Type	Name	Description
BIOLOGICAL	VHB937	VHB937 solution for infusion
BIOLOGICAL	VHB937	VHB937 solution for infusion
OTHER	Placebo	Solution for infusion

Timeline

• Start date: 2025-08-07
• Primary completion: 2028-09-14
• Completion: 2030-12-31
• First posted: 2025-07-30
• Last updated: 2026-03-23

Locations

52 sites across 12 countries: United States, Australia, Canada, Czechia, France, Germany, Japan, Netherlands, Poland, South Korea, Sweden, United Kingdom

Regulatory

• FDA-regulated drug study