Recruiting

Phase 2

VHB937A Clinical Trial to Learn About the Effects of VHB937 in People With Early Alzheimer's Disease

Sponsor:

Novartis Pharmaceuticals

Code:

NCT07094516

Conditions

Alzheimer's Disease

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Not accepted

Interventions

VHB937

Placebo

Study Details

Brief 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.

Conditions

Alzheimer's Disease

Study ID

NCT07094516

Start date

Aug 7, 2025

Status verified date

Jun, 2026

Completion date

Dec 31, 2030

Anticipated

Primary completion date

Sep 14, 2028

Anticipated

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Not accepted

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, Parkinson's disease, dementia with Lewy bodies, Huntington disease, vascular dementia.
History or current diagnosis of cardiac conditions or ECG abnormalities indicating significant risk of safety for participants in the study
Transient ischemic attacks (TIA) or stroke occurring within 12 months
Clinical evidence of liver or renal disease/injury
Current major depressive episode that is not adequately controlled, history of schizophrenia, other chronic psychosis
Significant neurological disease other than dementia (e.g. serious brain infection, traumatic brain injury, multiple concussions, epilepsy or recurrent seizures
Presence of suicidal ideation within 6 months or suicidal behavior within 2 years before Screening
Presence of cancer, HIV, Hep B, Hep C, uncontrolled thyroid disease, uncontrolled diabetes
Taking any prohibited medications

Other protocol-defined inclusion/exclusion criteria may apply

Study Design

Enrollment

407 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: VHB937 Low Dose

I.V. infusions

experimental: VHB937 High Dose

I.V. infusions

placebo comparator: Placebo

I.V. infusions

Interventions

VHB937

VHB937 solution for infusion

VHB937

VHB937 solution for infusion

Placebo

Solution for infusion

Primary outcome measure

Change from Baseline in the Clinical Dementia Rating scale - Sum of Boxes (CDR-SB) [ Time Frame: Baseline and Week 72 ]

Central Contacts and Locations

Central contacts

Novartis Pharmaceuticals

1-888-669-6682 novartis.email@novartis.com

Novartis Pharmaceuticals

+41613241111

Locations

Banner Alzheimers Institute

Recruiting

Phoenix, Arizona, United States, 85006

Principal Investigator:

Allison Perrin

Irvine Center for Clinical Research

Recruiting

Irvine, California, United States, 92618

Contacts

+1 949 753 1663#208

Principal Investigator:

Edward Zamrini

University of California San Diego

Recruiting

La Jolla, California, United States, 92037

Principal Investigator:

Gabriel Leger

University of California at Los Angeles

Recruiting

Los Angeles, California, United States, 90095

Principal Investigator:

Marie Kim

Jem Research Institute

Recruiting

Atlantis, Florida, United States, 33462-6608

Contacts

+1 561 968 2933

Principal Investigator:

Linda Pao

Visionary Investigators Network

Recruiting

Aventura, Florida, United States, 33180

Principal Investigator:

Jonathan Cross

K2 Medical Research LLC

Recruiting

Maitland, Florida, United States, 32751

Principal Investigator:

Sheila Baez Torres

K2 Medical Research LLC

Recruiting

Maitland, Florida, United States, 32751

Principal Investigator:

Craig Curtis

Renstar Medical Research

Recruiting

Ocala, Florida, United States, 34471

Contacts

+1 813 345 8210

Principal Investigator:

Anette Veronica Nieves

Charter Research The Villages

Recruiting

The Villages, Florida, United States, 32162

Principal Investigator:

Jeffrey Norton

Alzheimers Research Treatment Ctr

Recruiting

Wellington, Florida, United States, 33414

Principal Investigator:

Adam Falchook

Alzheimers Research Treatment Ctr

Recruiting

Wellington, Florida, United States, 33414

Contacts

+1 561 209 2400

Principal Investigator:

David Watson

Conquest Research

Recruiting

Winter Park, Florida, United States, 32789

Principal Investigator:

Malisa Agard

Hawaii Pacific Neuroscience LLC

Recruiting

Honolulu, Hawaii, United States, 96817

Principal Investigator:

Kore Liow

University of Kansas Hospital

Recruiting

Fairway, Kansas, United States, 66205

Contacts

+1 913 588 0555

Principal Investigator:

Townley Ryan

ActivMed Practices and Research

Recruiting

Methuen, Massachusetts, United States, 01844

Contacts

+1 978 462 9571

Principal Investigator:

Deborah Green-LaRoche

Citizens Memorial Hospital Neurology CLinic

Recruiting

Bolivar, Missouri, United States, 65613

Contacts

+1 417 841 3643

Principal Investigator:

Curtis Schreiber

Lou Ruvo Center for Brain Health

Recruiting

Las Vegas, Nevada, United States, 89106

Contacts

+1 702 483 6025

Principal Investigator:

Charles Bernick

UNC Hosp Invest Drug Serv Pharm

Recruiting

Chapel Hill, North Carolina, United States, 27514

Principal Investigator:

Andrea Bozoki

The Ohio State University

Recruiting

Columbus, Ohio, United States, 43210

Principal Investigator:

Douglas W Scharre

Neural Net Research

Recruiting

Portland, Oregon, United States, 97225

Principal Investigator:

Michael S Mega

Abington Neurological Associates Ltd

Recruiting

Willow Grove, Pennsylvania, United States, 19090

Contacts

+1 215 957 9250 #57

Principal Investigator:

David Weisman

University of Texas Health Science Center at San Antonio

Recruiting

San Antonio, Texas, United States, 78229-3900

Contacts

+1 210 567 8229

Principal Investigator:

Sudha Seshadri

University of Washington Medical Center

Recruiting

Seattle, Washington, United States, 98195

Principal Investigator:

Michael Rosenbloom

Novartis Investigative Site

Recruiting

London, Ontario, Canada, N6G 3H7

Novartis Investigative Site

Recruiting

North York, Ontario, Canada, M6A 2C8

Novartis Investigative Site

Recruiting

Ottawa, Ontario, Canada, K1N 5C8

Novartis Investigative Site

Recruiting

Toronto, Ontario, Canada, M3B 2S7

Novartis Investigative Site

Recruiting

Toronto, Ontario, Canada, M5T 2S8

More Information

Sponsor

Novartis Pharmaceuticals

Last update posted

Jun 26, 2026

Last verified

Jun, 2026

Keywords

Alzheimer's disease
AD
Dementia
Monoclonal Antibody

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Novartis Pharmaceuticals on 2026-06-26.