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
Location: See all (8) locations...
Intervention Type: Other, Biological
Study Type: Interventional
Study Phase: Phase 2
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 50
Maximum Age: 85
Healthy Volunteers: f
View:
• 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
Locations
United States
Florida
Jem Research Institute
RECRUITING
Atlantis
Visionary Investigators Network
RECRUITING
Aventura
K2 Medical Research LLC
RECRUITING
Maitland
Charter Research The Villages
RECRUITING
The Villages
Massachusetts
ActivMed Practices and Research
RECRUITING
Methuen
Pennsylvania
Abington Neurological Associates Ltd
RECRUITING
Willow Grove
Other Locations
Canada
Novartis Investigative Site
RECRUITING
Toronto
United Kingdom
Novartis Investigative Site
RECRUITING
London
Contact Information
Primary
Novartis Pharmaceuticals
novartis.email@novartis.com
1-888-669-6682
Backup
Novartis Pharmaceuticals
+41613241111
Time Frame
Start Date: 2025-08-07
Estimated Completion Date: 2030-12-31
Participants
Target number of participants: 407
Treatments
Experimental: VHB937 Low Dose
I.V. infusions
Experimental: VHB937 High Dose
I.V. infusions
Placebo_comparator: Placebo
I.V. infusions
Related Therapeutic Areas
Sponsors
Leads: Novartis Pharmaceuticals