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NCT07094516PHASE2Recruiting

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

Novartis Pharmaceuticals

Start Date

8/7/2025

Completion Date

12/31/2030

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.

Detailed 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 Criteria

Age Range: 50 years to 85 years

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

Interventions

BIOLOGICAL

VHB937

BIOLOGICAL

VHB937

OTHER

Placebo

Interested in This Trial?

Contact the trial locations directly using the information below to learn more about enrollment.

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Conditions

Alzheimer's Disease

Locations

Banner Alzheimers Institute

Phoenix, Arizona 85006

United States

Irvine Center for Clinical Research

Irvine, California 92618

United States

University of California San Diego

La Jolla, California 92037

United States

University of California at Los Angeles

Los Angeles, California 90095

United States

Jem Research Institute

Atlantis, Florida 33462-6608

United States

Visionary Investigators Network

Aventura, Florida 33180

United States

K2 Medical Research LLC

Maitland, Florida 32751

United States

K2 Medical Research LLC

Maitland, Florida 32751

United States

Renstar Medical Research

Ocala, Florida 34471

United States

Charter Research The Villages

The Villages, Florida 32162

United States

Alzheimers Research Treatment Ctr

Wellington, Florida 33414

United States

Alzheimers Research Treatment Ctr

Wellington, Florida 33414

United States

Conquest Research

Winter Park, Florida 32789

United States

Hawaii Pacific Neuroscience LLC

Honolulu, Hawaii 96817

United States

University of Kansas Hospital

Fairway, Kansas 66205

United States

ActivMed Practices and Research

Methuen, Massachusetts 01844

United States

Citizens Memorial Hospital Neurology CLinic

Bolivar, Missouri 65613

United States

Lou Ruvo Center for Brain Health

Las Vegas, Nevada 89106

United States

UNC Hosp Invest Drug Serv Pharm

Chapel Hill, North Carolina 27514

United States

The Ohio State University

Columbus, Ohio 43210

United States

Neural Net Research

Portland, Oregon 97225

United States

Abington Neurological Associates Ltd

Willow Grove, Pennsylvania 19090

United States

University of Texas Health Science Center at San Antonio

San Antonio, Texas 78229-3900

United States

University of Washington Medical Center

Seattle, Washington 98195

United States

Novartis Investigative Site

Camperdown, New South Wales 2050

Australia

Novartis Investigative Site

Kogarah, New South Wales 2217

Australia

Novartis Investigative Site

Box Hill, Victoria 3128

Australia

Novartis Investigative Site

Heidelberg, Victoria 3084

Australia

Novartis Investigative Site

Nedlands, Western Australia 6009

Australia

Novartis Investigative Site

London, Ontario N6G 3H7

Canada

Novartis Investigative Site

North York, Ontario M6A 2C8

Canada

Novartis Investigative Site

Ottawa, Ontario K1N 5C8

Canada

Novartis Investigative Site

Toronto, Ontario M3B 2S7

Canada

Novartis Investigative Site

Toronto, Ontario M5T 2S8

Canada

Novartis Investigative Site

Hangzhou, Zhejiang 310002

China

Novartis Investigative Site

Shanghai, 200040

China

Novartis Investigative Site

Brno, 602 00

Czechia

Novartis Investigative Site

Prague, 160 00

Czechia

Novartis Investigative Site

Toulouse, Haute Garonne 31059

France

Novartis Investigative Site

Paris, 75013

France

Novartis Investigative Site

Berlin, State of Berlin 12200

Germany

Novartis Investigative Site

Berlin, 13353

Germany

Novartis Investigative Site

München, 80377

Germany

Novartis Investigative Site

Cefalù, PA 90015

Italy

Novartis Investigative Site

Perugia, PG 06129

Italy

Novartis Investigative Site

Ōbu, Aichi-ken 4748511

Japan

Novartis Investigative Site

Fujioka, Gunma 375-0017

Japan

Novartis Investigative Site

Itabashi Ku, Tokyo 1730015

Japan

Novartis Investigative Site

Kodaira, Tokyo 187-8551

Japan

Novartis Investigative Site

Shinjuku Ku, Tokyo 160-0023

Japan

Novartis Investigative Site

Amsterdam, 1081 GN

Netherlands

Novartis Investigative Site

Bialystok, 15-756

Poland

Novartis Investigative Site

Oświęcim, 32-600

Poland

Novartis Investigative Site

Wroclaw, 53659

Poland

Novartis Investigative Site

Seoul, Korea 05505

South Korea

Novartis Investigative Site

Seoul, Seoul 03080

South Korea

Novartis Investigative Site

Seoul, Seoul 05030

South Korea

Novartis Investigative Site

Incheon, 21565

South Korea

Novartis Investigative Site

Incheon, 22332

South Korea

Novartis Investigative Site

Seoul, 04763

South Korea

Novartis Investigative Site

Pamplona, Navarre 31008

Spain

Novartis Investigative Site

Valencia, Valencia 46017

Spain

Novartis Investigative Site

Valencia, 46026

Spain

Novartis Investigative Site

Mölndal, 431 80

Sweden

Novartis Investigative Site

Stockholm, 141 86

Sweden

Novartis Investigative Site

Edinburgh, Lothian EH12 5PJ

United Kingdom

Novartis Investigative Site

Oxford, Oxfordshire OX3 7JX

United Kingdom

Novartis Investigative Site

Aberdeen, AB25 2ZH

United Kingdom

Novartis Investigative Site

London, SE5 8AF

United Kingdom

Novartis Investigative Site

London, W1G 9JF

United Kingdom

Novartis Investigative Site

London, WC1N 3BG

United Kingdom

Novartis Investigative Site

Newcastle upon Tyne, NE4 6BE

United Kingdom

Novartis Investigative Site

Salford, M6 8HD

United Kingdom

Novartis Investigative Site

Southampton, SO16 6YD

United Kingdom