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

Last updated: June 25, 2026
Sponsor: Novartis Pharmaceuticals
Overall Status: Active - Recruiting

Phase

2

Condition

Alzheimer's Disease

Memory Loss

Dementia

Treatment

VHB937

Placebo

Clinical Study ID

NCT07094516
CVHB937A12201
  • Ages 50-85
  • All Genders

Study 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 Criteria

Inclusion

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

Total Participants: 407
Treatment Group(s): 2
Primary Treatment: VHB937
Phase: 2
Study Start date:
August 07, 2025
Estimated Completion Date:
December 31, 2030

Study 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.

Connect with a study center

  • Novartis Investigative Site

    Camperdown, New South Wales 2050
    Australia

    Active - Recruiting

  • Novartis Investigative Site

    Kogarah, New South Wales 2217
    Australia

    Active - Recruiting

  • Novartis Investigative Site

    Box Hill, Victoria 3128
    Australia

    Active - Recruiting

  • Novartis Investigative Site

    Heidelberg, Victoria 3084
    Australia

    Active - Recruiting

  • Novartis Investigative Site

    Nedlands, Western Australia 6009
    Australia

    Active - Recruiting

  • Novartis Investigative Site

    London, Ontario N6G 3H7
    Canada

    Active - Recruiting

  • Novartis Investigative Site

    North York, Ontario M6A 2C8
    Canada

    Active - Recruiting

  • Novartis Investigative Site

    Ottawa, Ontario K1N 5C8
    Canada

    Active - Recruiting

  • Novartis Investigative Site

    Toronto, Ontario M3B 2S7
    Canada

    Active - Recruiting

  • Novartis Investigative Site

    Hangzhou, Zhejiang 310002
    China

    Active - Recruiting

  • Novartis Investigative Site

    Shanghai, 200040
    China

    Active - Recruiting

  • Novartis Investigative Site

    Brno, 602 00
    Czechia

    Active - Recruiting

  • Novartis Investigative Site

    Prague, 160 00
    Czechia

    Active - Recruiting

  • Novartis Investigative Site

    Toulouse, Haute Garonne 31059
    France

    Active - Recruiting

  • Novartis Investigative Site

    Paris, 75013
    France

    Active - Recruiting

  • Novartis Investigative Site

    Berlin, 13353
    Germany

    Active - Recruiting

  • Novartis Investigative Site

    München, 80377
    Germany

    Active - Recruiting

  • Novartis Investigative Site

    Cefalù, PA 90015
    Italy

    Active - Recruiting

  • Novartis Investigative Site

    Perugia, PG 06129
    Italy

    Active - Recruiting

  • Novartis Investigative Site

    Ōbu, Aichi-ken 4748511
    Japan

    Active - Recruiting

  • Novartis Investigative Site

    Fujioka, Gunma 375-0017
    Japan

    Active - Recruiting

  • Novartis Investigative Site

    Itabashi Ku, Tokyo 1730015
    Japan

    Active - Recruiting

  • Novartis Investigative Site

    Kodaira, Tokyo 187-8551
    Japan

    Active - Recruiting

  • Novartis Investigative Site

    Shinjuku Ku, Tokyo 160-0023
    Japan

    Active - Recruiting

  • Novartis Investigative Site

    Amsterdam, 1081 GN
    Netherlands

    Active - Recruiting

  • Novartis Investigative Site

    Bialystok, 15-756
    Poland

    Active - Recruiting

  • Novartis Investigative Site

    Oświęcim, 32-600
    Poland

    Active - Recruiting

  • Novartis Investigative Site

    Wroclaw, 53659
    Poland

    Active - Recruiting

  • Novartis Investigative Site

    Seoul, Seoul 03080
    South Korea

    Active - Recruiting

  • Novartis Investigative Site

    Incheon, 21565
    South Korea

    Active - Recruiting

  • Novartis Investigative Site

    Pamplona, Navarre 31008
    Spain

    Active - Recruiting

  • Novartis Investigative Site

    Valencia, 46026
    Spain

    Active - Recruiting

  • Novartis Investigative Site

    Mölndal, 431 80
    Sweden

    Active - Recruiting

  • Novartis Investigative Site

    Stockholm, 141 86
    Sweden

    Active - Recruiting

  • Novartis Investigative Site

    Edinburgh, Lothian EH12 5PJ
    United Kingdom

    Active - Recruiting

  • Novartis Investigative Site

    Oxford, Oxfordshire OX3 7JX
    United Kingdom

    Active - Recruiting

  • Novartis Investigative Site

    Aberdeen, AB25 2ZH
    United Kingdom

    Active - Recruiting

  • Novartis Investigative Site

    London, SE5 8AF
    United Kingdom

    Active - Recruiting

  • Novartis Investigative Site

    Newcastle upon Tyne, NE4 6BE
    United Kingdom

    Active - Recruiting

  • Novartis Investigative Site

    Salford, M6 8HD
    United Kingdom

    Active - Recruiting

  • Novartis Investigative Site

    Southampton, SO16 6YD
    United Kingdom

    Active - Recruiting

  • Banner Alzheimers Institute

    Phoenix, Arizona 85006
    United States

    Active - Recruiting

  • Irvine Center for Clinical Research

    Irvine, California 92618
    United States

    Active - Recruiting

  • University of California San Diego

    La Jolla, California 92037
    United States

    Active - Recruiting

  • University of California at Los Angeles

    Los Angeles, California 90095
    United States

    Active - Recruiting

  • Jem Research Institute

    Atlantis, Florida 33462-6608
    United States

    Active - Recruiting

  • Visionary Investigators Network

    Aventura, Florida 33180
    United States

    Active - Recruiting

  • K2 Medical Research LLC

    Maitland, Florida 32751
    United States

    Active - Recruiting

  • Renstar Medical Research

    Ocala, Florida 34471
    United States

    Active - Recruiting

  • Charter Research The Villages

    The Villages, Florida 32162
    United States

    Active - Recruiting

  • Alzheimers Research Treatment Ctr

    Wellington, Florida 33414
    United States

    Active - Recruiting

  • Conquest Research

    Winter Park, Florida 32789
    United States

    Active - Recruiting

  • K2 Medical Research LLC

    Maitland 4163220, Florida 4155751 32751
    United States

    Active - Recruiting

  • Hawaii Pacific Neuroscience LLC

    Honolulu, Hawaii 96817
    United States

    Active - Recruiting

  • University of Kansas Hospital

    Fairway, Kansas 66205
    United States

    Active - Recruiting

  • ActivMed Practices and Research

    Methuen, Massachusetts 01844
    United States

    Active - Recruiting

  • Citizens Memorial Hospital Neurology CLinic

    Bolivar, Missouri 65613
    United States

    Active - Recruiting

  • Lou Ruvo Center for Brain Health

    Las Vegas, Nevada 89106
    United States

    Active - Recruiting

  • UNC Hosp Invest Drug Serv Pharm

    Chapel Hill, North Carolina 27514
    United States

    Active - Recruiting

  • The Ohio State University

    Columbus, Ohio 43210
    United States

    Active - Recruiting

  • Neural Net Research

    Portland, Oregon 97225
    United States

    Active - Recruiting

  • Abington Neurological Associates Ltd

    Willow Grove, Pennsylvania 19090
    United States

    Active - Recruiting

  • University of Texas Health Science Center at San Antonio

    San Antonio, Texas 78229-3900
    United States

    Active - Recruiting

  • University of Washington Medical Center

    Seattle, Washington 98195
    United States

    Active - Recruiting

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