A Randomized, Placebo-controlled, Parallel Group, 72-week Study to Evaluate the Efficacy and Safety of VHB937 in Participants With Early Alzheimers Disease Followed by an Extension

What this Trial Is About

Researchers are evaluating the safety and effects of a drug called VHB937 in people with early Alzheimers disease. This is a Phase II, multicenter, randomized, double-blind, placebo-controlled study that lasts 72 weeks, followed by an extension phase. The study aims to see if VHB937 can safely improve memory, thinking abilities, daily activities, and brain changes in individuals diagnosed with mild cognitive impairment or mild Alzheimers disease confirmed by specific biomarkers. Participants will receive intravenous infusions of either a low dose or high dose of VHB937, or a placebo. The study groups are assigned randomly and neither the participant nor the researchers know who receives which treatment during the 72-week double-blind period. After this, there is an extension phase to continue monitoring participants. During the study, participants will have regular assessments including memory and cognitive tests, evaluations of daily living activities, brain imaging, and blood tests to track how the body processes the drug and its immune response. Safety will be monitored by recording any adverse events throughout the study, which can last up to about 63 months. The main outcome measured is the change in the Clinical Dementia Rating scale over 72 weeks.

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