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
Novartis Pharmaceuticals
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.
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.
Eligibility
- Age range
- 50–85 years
- Sex
- All
- Healthy volunteers
- No
Key Inclusion Criteria * Male or female participants 50 to 85 years of age * Diagnosis of Mild Cognitive Impairment (MCI) due to AD or mild AD * Clinical Dementia Rating (CDR) Global score of 0.5 or 1.0 * Confirmation of AD based on cerebral spinal fluid (CSF) biomarkers or amyloid PET imaging * Reliable study partner who can accompany the participant at study visits * If on symptomatic AD treatment (AChEIs/memantine), on a stable dose prior to starting study treatment Key Exclusion Criteria * Dementia due to a condition other than AD, including but not limited to, frontal temporal dementia…
Interventions
- BiologicalVHB937
VHB937 solution for infusion
- BiologicalVHB937
VHB937 solution for infusion
- OtherPlacebo
Solution for infusion
Locations (52)
- Banner Alzheimers InstitutePhoenix, Arizona
- University of California San DiegoLa Jolla, California
- University of California at Los AngelesLos Angeles, California
- Jem Research InstituteAtlantis, Florida
- Visionary Investigators NetworkAventura, Florida
- K2 Medical Research LLCMaitland, Florida