RecruitingPhase 2NCT07094516

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

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

Sponsor

Novartis Pharmaceuticals

Enrollment

407 participants

Start Date

Aug 7, 2025

Study Type

INTERVENTIONAL

Conditions

Alzheimer s Disease

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

Min Age: 50 YearsMax Age: 85 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new drug called VHB937 in people with early-stage Alzheimer's disease — specifically those with mild memory problems (mild cognitive impairment due to Alzheimer's) or mild Alzheimer's dementia. The goal is to see if the drug is safe and whether it slows the progression of the disease. **You may be eligible if...** - You are between 50 and 85 years old - You have been diagnosed with mild cognitive impairment or mild Alzheimer's disease - Your diagnosis is confirmed by spinal fluid tests or a special brain scan (amyloid PET) - You have a reliable friend or family member who can accompany you to visits - If you are already taking Alzheimer's medications (such as donepezil or memantine), you have been on a stable dose **You may NOT be eligible if...** - Your memory problems are caused by something other than Alzheimer's disease (e.g., Parkinson's, Lewy body dementia, vascular dementia) - You have significant heart problems or abnormal heart rhythms - You have had a stroke or mini-stroke (TIA) in the past 12 months - You have liver or kidney disease, uncontrolled depression, schizophrenia, epilepsy, or active cancer - You have had thoughts of suicide in the past 6 months Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALVHB937

VHB937 solution for infusion

BIOLOGICALVHB937

VHB937 solution for infusion

OTHERPlacebo

Solution for infusion

Locations(52)

Banner Alzheimers Institute

Phoenix, Arizona, United States

University of California San Diego

La Jolla, California, United States

University of California at Los Angeles

Los Angeles, California, United States

Jem Research Institute

Atlantis, Florida, United States

Visionary Investigators Network

Aventura, Florida, United States

K2 Medical Research LLC

Maitland, Florida, United States

K2 Medical Research LLC

Maitland, Florida, United States

Renstar Medical Research

Ocala, Florida, United States

Charter Research The Villages

The Villages, Florida, United States

Alzheimers Research Treatment Ctr

Wellington, Florida, United States

Alzheimers Research Treatment Ctr

Wellington, Florida, United States

Conquest Research

Winter Park, Florida, United States

Hawaii Pacific Neuroscience LLC

Honolulu, Hawaii, United States

University of Kansas Hospital

Fairway, Kansas, United States

ActivMed Practices and Research

Methuen, Massachusetts, United States

Citizens Memorial Hospital Neurology CLinic

Bolivar, Missouri, United States

UNC Hosp Invest Drug Serv Pharm

Chapel Hill, North Carolina, United States

The Ohio State University

Columbus, Ohio, United States

Neural Net Research

Portland, Oregon, United States

Abington Neurological Associates Ltd

Willow Grove, Pennsylvania, United States

University of Texas Health Science Center at San Antonio

San Antonio, Texas, United States

University of Washington Medical Center

Seattle, Washington, United States

Novartis Investigative Site

Camperdown, New South Wales, Australia

Novartis Investigative Site

Kogarah, New South Wales, Australia

Novartis Investigative Site

Box Hill, Victoria, Australia

Novartis Investigative Site

North York, Ontario, Canada

Novartis Investigative Site

Toronto, Ontario, Canada

Novartis Investigative Site

Brno, Czechia

Novartis Investigative Site

Prague, Czechia

Novartis Investigative Site

Toulouse, Haute Garonne, France

Novartis Investigative Site

Paris, France

Novartis Investigative Site

Berlin, Germany

Novartis Investigative Site

Berlin, Germany

Novartis Investigative Site

München, Germany

Novartis Investigative Site

Itabashi Ku, Tokyo, Japan

Novartis Investigative Site

Kodaira, Tokyo, Japan

Novartis Investigative Site

Shinjuku Ku, Tokyo, Japan

Novartis Investigative Site

Amsterdam, Netherlands

Novartis Investigative Site

Bialystok, Poland

Novartis Investigative Site

Wroclaw, Poland

Novartis Investigative Site

Seoul, Korea, South Korea

Novartis Investigative Site

Seoul, Korea, South Korea

Novartis Investigative Site

Incheon, South Korea

Novartis Investigative Site

Incheon, South Korea

Novartis Investigative Site

Seoul, South Korea

Novartis Investigative Site

Seoul, South Korea

Novartis Investigative Site

Mölndal, Sweden

Novartis Investigative Site

Stockholm, Sweden

Novartis Investigative Site

Aberdeen, United Kingdom

Novartis Investigative Site

London, United Kingdom

Novartis Investigative Site

London, United Kingdom

Novartis Investigative Site

Southampton, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT07094516

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