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 (49) 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
Arizona
Banner Alzheimers Institute
RECRUITING
Phoenix
California
University of California San Diego
RECRUITING
La Jolla
University of California at Los Angeles
RECRUITING
Los Angeles
Florida
Jem Research Institute
RECRUITING
Atlantis
Visionary Investigators Network
RECRUITING
Aventura
K2 Medical Research LLC
RECRUITING
Maitland
Renstar Medical Research
RECRUITING
Ocala
Charter Research The Villages
RECRUITING
The Villages
Alzheimers Research Treatment Ctr
RECRUITING
Wellington
Alzheimers Research Treatment Ctr
RECRUITING
Wellington
Conquest Research
RECRUITING
Winter Park
Hawaii
Hawaii Pacific Neuroscience LLC
RECRUITING
Honolulu
Kansas
University of Kansas Hospital
RECRUITING
Fairway
Massachusetts
ActivMed Practices and Research
RECRUITING
Methuen
Missouri
Citizens Memorial Hospital Neurology CLinic
RECRUITING
Bolivar
North Carolina
UNC Hosp Invest Drug Serv Pharm
RECRUITING
Chapel Hill
Ohio
The Ohio State University
RECRUITING
Columbus
Oregon
Neural Net Research
RECRUITING
Portland
Pennsylvania
Abington Neurological Associates Ltd
RECRUITING
Willow Grove
Texas
University of Texas Health Science Center at San Antonio
RECRUITING
San Antonio
Washington
University of Washington Medical Center
RECRUITING
Seattle
Other Locations
Australia
Novartis Investigative Site
RECRUITING
Box Hill
Novartis Investigative Site
RECRUITING
Camperdown
Novartis Investigative Site
RECRUITING
Kogarah
Canada
Novartis Investigative Site
RECRUITING
North York
Novartis Investigative Site
RECRUITING
Toronto
France
Novartis Investigative Site
RECRUITING
Paris
Novartis Investigative Site
RECRUITING
Toulouse
Germany
Novartis Investigative Site
RECRUITING
Berlin
Novartis Investigative Site
RECRUITING
Berlin
Novartis Investigative Site
RECRUITING
München
Japan
Novartis Investigative Site
RECRUITING
Itabashi Ku
Novartis Investigative Site
RECRUITING
Kodaira
Novartis Investigative Site
RECRUITING
Shinjuku Ku
Netherlands
Novartis Investigative Site
RECRUITING
Amsterdam
Poland
Novartis Investigative Site
RECRUITING
Bialystok
Novartis Investigative Site
RECRUITING
Wroclaw
Republic of Korea
Novartis Investigative Site
RECRUITING
Incheon
Novartis Investigative Site
RECRUITING
Incheon
Novartis Investigative Site
RECRUITING
Seoul
Novartis Investigative Site
RECRUITING
Seoul
Novartis Investigative Site
RECRUITING
Seoul
Novartis Investigative Site
RECRUITING
Seoul
Sweden
Novartis Investigative Site
RECRUITING
Mölndal
Novartis Investigative Site
RECRUITING
Stockholm
United Kingdom
Novartis Investigative Site
RECRUITING
Aberdeen
Novartis Investigative Site
RECRUITING
London
Novartis Investigative Site
RECRUITING
London
Novartis Investigative Site
RECRUITING
Southampton
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