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

May 13, 2026 updated by: Novartis Pharmaceuticals

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

407

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Novartis Pharmaceuticals
  • Phone Number: +41613241111

Study Locations

  • Australia
    • New South Wales
      • Camperdown, New South Wales, Australia, 2050
        • Recruiting
        • Novartis Investigative Site
      • Kogarah, New South Wales, Australia, 2217
        • Recruiting
        • Novartis Investigative Site
    • Victoria
      • Box Hill, Victoria, Australia, 3128
        • Recruiting
        • Novartis Investigative Site
  • Canada
    • Ontario
      • London, Ontario, Canada, N6G 3H7
        • Recruiting
        • Novartis Investigative Site
      • North York, Ontario, Canada, M6A 2C8
        • Recruiting
        • Novartis Investigative Site
      • Toronto, Ontario, Canada, M5T 2S8
        • Recruiting
        • Novartis Investigative Site
      • Toronto, Ontario, Canada, M3B 2S7
        • Recruiting
        • Novartis Investigative Site
  • Czechia
      • Brno, Czechia, 602 00
        • Recruiting
        • Novartis Investigative Site
      • Prague, Czechia, 160 00
        • Recruiting
        • Novartis Investigative Site
  • France
      • Paris, France, 75013
        • Recruiting
        • Novartis Investigative Site
    • Haute Garonne
      • Toulouse, Haute Garonne, France, 31059
        • Recruiting
        • Novartis Investigative Site
  • Germany
      • Berlin, Germany, 13353
        • Recruiting
        • Novartis Investigative Site
      • Berlin, Germany, 12200
        • Recruiting
        • Novartis Investigative Site
      • München, Germany, 80377
        • Recruiting
        • Novartis Investigative Site
  • Italy
    • PA
      • Cefalù, PA, Italy, 90015
        • Recruiting
        • Novartis Investigative Site
    • PG
      • Perugia, PG, Italy, 06129
        • Recruiting
        • Novartis Investigative Site
  • Japan
    • Tokyo
      • Itabashi Ku, Tokyo, Japan, 1730015
        • Recruiting
        • Novartis Investigative Site
      • Kodaira, Tokyo, Japan, 187-8551
        • Recruiting
        • Novartis Investigative Site
      • Shinjuku Ku, Tokyo, Japan, 160-0023
        • Recruiting
        • Novartis Investigative Site
  • Netherlands
      • Amsterdam, Netherlands, 1081 GN
        • Recruiting
        • Novartis Investigative Site
  • Poland
      • Bialystok, Poland, 15-756
        • Recruiting
        • Novartis Investigative Site
      • Oświęcim, Poland, 32-600
        • Recruiting
        • Novartis Investigative Site
      • Wroclaw, Poland, 53659
        • Recruiting
        • Novartis Investigative Site
  • South Korea
      • Incheon, South Korea, 21565
        • Recruiting
        • Novartis Investigative Site
      • Incheon, South Korea, 22332
        • Recruiting
        • Novartis Investigative Site
      • Seoul, South Korea, 03080
        • Recruiting
        • Novartis Investigative Site
      • Seoul, South Korea, 04763
        • Recruiting
        • Novartis Investigative Site
      • Seoul, South Korea, 05030
        • Recruiting
        • Novartis Investigative Site
    • Korea
      • Seoul, Korea, South Korea, 05505
        • Recruiting
        • Novartis Investigative Site
  • Spain
      • Valencia, Spain, 46026
        • Recruiting
        • Novartis Investigative Site
    • Navarre
      • Pamplona, Navarre, Spain, 31008
        • Recruiting
        • Novartis Investigative Site
    • Valencia
      • Valencia, Valencia, Spain, 46017
        • Recruiting
        • Novartis Investigative Site
  • Sweden
      • Mölndal, Sweden, 431 80
        • Recruiting
        • Novartis Investigative Site
      • Stockholm, Sweden, 141 86
        • Recruiting
        • Novartis Investigative Site
  • United Kingdom
      • Aberdeen, United Kingdom, AB25 2ZH
        • Recruiting
        • Novartis Investigative Site
      • London, United Kingdom, WC1N 3BG
        • Recruiting
        • Novartis Investigative Site
      • London, United Kingdom, W1G 9JF
        • Recruiting
        • Novartis Investigative Site
      • London, United Kingdom, SE5 8AF
        • Recruiting
        • Novartis Investigative Site
      • Newcastle upon Tyne, United Kingdom, NE4 6BE
        • Recruiting
        • Novartis Investigative Site
      • Southampton, United Kingdom, SO16 6YD
        • Recruiting
        • Novartis Investigative Site
    • Lothian
      • Edinburgh, Lothian, United Kingdom, EH12 5PJ
        • Recruiting
        • Novartis Investigative Site
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85006
        • Recruiting
        • Banner Alzheimers Institute
        • Principal Investigator:
          • Allison Perrin
    • California
      • Irvine, California, United States, 92618
        • Recruiting
        • Irvine Center for Clinical Research
        • Principal Investigator:
          • Edward Zamrini
        • Contact:
          • Phone Number: +1 949 753 1663#208
      • La Jolla, California, United States, 92037
        • Recruiting
        • University of California San Diego
        • Principal Investigator:
          • Gabriel Leger
      • Los Angeles, California, United States, 90095
        • Recruiting
        • University of California at Los Angeles
        • Principal Investigator:
          • Marie Kim
    • Florida
      • Atlantis, Florida, United States, 33462-6608
        • Recruiting
        • JEM Research Institute
        • Contact:
          • Phone Number: 561-968-2933
        • Principal Investigator:
          • Linda Pao
      • Aventura, Florida, United States, 33180
        • Recruiting
        • Visionary Investigators Network
        • Principal Investigator:
          • Jonathan Cross
      • Maitland, Florida, United States, 32751
        • Recruiting
        • K2 Medical Research LLC
        • Principal Investigator:
          • Craig Curtis
      • Ocala, Florida, United States, 34471
        • Recruiting
        • Renstar Medical Research
        • Contact:
          • Phone Number: +1 813 345 8210
        • Principal Investigator:
          • Anette Veronica Nieves
      • The Villages, Florida, United States, 32162
        • Recruiting
        • Charter Research The Villages
        • Principal Investigator:
          • Jeffrey Norton
      • Wellington, Florida, United States, 33414
        • Recruiting
        • Alzheimers Research Treatment Ctr
        • Contact:
          • Phone Number: 561-209-2400
        • Principal Investigator:
          • David Watson
      • Winter Park, Florida, United States, 32789
        • Recruiting
        • Conquest Research
        • Principal Investigator:
          • Malisa Agard
    • Hawaii
      • Honolulu, Hawaii, United States, 96817
        • Recruiting
        • Hawaii Pacific Neuroscience LLC
        • Principal Investigator:
          • Kore Liow
    • Kansas
      • Fairway, Kansas, United States, 66205
        • Recruiting
        • University of Kansas Hospital
        • Contact:
          • Phone Number: 913-588-0555
        • Principal Investigator:
          • Townley Ryan
    • Massachusetts
      • Methuen, Massachusetts, United States, 01844
        • Recruiting
        • ActivMed Practices and Research
        • Principal Investigator:
          • Deborah Green-LaRoche
        • Contact:
          • Phone Number: 978-462-9571
    • Missouri
      • Bolivar, Missouri, United States, 65613
        • Recruiting
        • Citizens Memorial Hospital Neurology CLinic
        • Principal Investigator:
          • Curtis Schreiber
        • Contact:
          • Phone Number: 417-841-3643
    • Nevada
      • Las Vegas, Nevada, United States, 89106
        • Recruiting
        • Lou Ruvo Center for Brain Health
        • Principal Investigator:
          • Charles Bernick
        • Contact:
          • Phone Number: 702-483-6025
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27514
        • Recruiting
        • UNC Hosp Invest Drug Serv Pharm
        • Principal Investigator:
          • Andrea Bozoki
    • Ohio
      • Columbus, Ohio, United States, 43210
        • Recruiting
        • The Ohio State University
        • Principal Investigator:
          • Douglas W Scharre
    • Oregon
      • Portland, Oregon, United States, 97225
        • Recruiting
        • Neural Net Research
        • Principal Investigator:
          • Michael S Mega
    • Pennsylvania
      • Willow Grove, Pennsylvania, United States, 19090
        • Recruiting
        • Abington Neurological Associates Ltd
        • Principal Investigator:
          • David Weisman
        • Contact:
          • Phone Number: +1 215 957 9250 #57
    • Texas
      • San Antonio, Texas, United States, 78229-3900
        • Recruiting
        • University of Texas Health Science Center at San Antonio
        • Contact:
          • Phone Number: 210-567-8229
        • Principal Investigator:
          • Sudha Seshadri
    • Washington
      • Seattle, Washington, United States, 98195
        • Recruiting
        • University of Washington Medical Center
        • Principal Investigator:
          • Michael Rosenbloom

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: VHB937 Low Dose
I.V. infusions
Biological: VHB937
VHB937 solution for infusion
Experimental: VHB937 High Dose
I.V. infusions
Biological: VHB937
VHB937 solution for infusion
Placebo Comparator: Placebo
I.V. infusions
Other: Placebo
Solution for infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline in the Clinical Dementia Rating scale - Sum of Boxes (CDR-SB)
Time Frame: Baseline and Week 72
The CDR is a measure of cognition and function, widely used in clinical research in AD. The scale assesses six domains: Memory, Orientation, Judgment & Problem Solving, Community Affairs, Home & Hobbies, and Personal Care. Based on in-depth semi-structured interview, each domain is assigned a score, which is summed to obtain the Sum of Boxes (SB) score, ranging from 0 to 18 with higher scores indicating worse condition
Baseline and Week 72

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time Frame: From First treatment to end of study (up to 63 months approximately)
Incidence and severity of AEs and SAEs by treatment group, including Safety findings, Laboratory tests, Vital signs and, ECG findings qualifying and reported as AEs.
From First treatment to end of study (up to 63 months approximately)
Change from Baseline in Clinical Dementia Rating scale - Sum of Boxes (CDR-SB)
Time Frame: Baseline over time until Week 72
The CDR is a measure of cognition and function, widely used in clinical research in AD. The scale assesses six domains: Memory, Orientation, Judgment & Problem Solving, Community Affairs, Home & Hobbies, and Personal Care.
Baseline over time until Week 72
Change from Baseline in Alzheimer's Disease Assessment Scale-Cognitive (ADAS-Cog14)
Time Frame: Baseline over time until Week 72
The ADAS-Cog is is a 14-item clinical assessment tool to measure cognition. The ADAS-Cog14 score ranges between 0 and 90, with higher scores indicating worse cognitive performance
Baseline over time until Week 72
Change from Baseline in instrumental activities of daily living (iADL) on the Alzheimers Disease Cooperative Study - Activities of Daily Living (ADCS-ADL) scale
Time Frame: Baseline over time until Week 72
The ADCS-ADL is a 23-item study partner scale designed to assess the ability of patients with AD to carry out basic activities of daily living (bADLs) and instrumental activities of daily living (iADLs). For each item, the study partner is asked whether the participant attempted the activity in the 4 preceding weeks. Where 'yes' is the answer, the study partner is asked to rate the patient's level of performance according to a set of descriptors tailored to that activity. Scores on iADL sub-scale range between 0 and 59, with lower scores reflecting greater disease severity
Baseline over time until Week 72
Pharmacokinetic parameters of VHB937 in serum - Cmax
Time Frame: Baseline over time until Week 72
Cmax - The maximum concentration of VHB937 in serum
Baseline over time until Week 72
Pharmacokinetic parameters of VHB937 in serum - Tmax
Time Frame: Baseline over time until Week 72
Tmax - The time to reach the maximum concentration of VHB937 in serum
Baseline over time until Week 72
Pharmacokinetic parameters of VHB937 in serum - Ctrough
Time Frame: Baseline over time until Week 72
Ctrough - Minimum observed concentration of VHB937 in CSF
Baseline over time until Week 72
VHB937 immunogenicity in serum
Time Frame: Baseline over time until Week 72
Determination of anti-VHB937 antibodies in serum at selected timepoints
Baseline over time until Week 72

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 7, 2025

Primary Completion (Estimated)

September 14, 2028

Study Completion (Estimated)

December 31, 2030

Study Registration Dates

First Submitted

July 23, 2025

First Submitted That Met QC Criteria

July 23, 2025

First Posted (Actual)

July 30, 2025

Study Record Updates

Last Update Posted (Actual)

May 14, 2026

Last Update Submitted That Met QC Criteria

May 13, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CVHB937A12201

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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