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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
407

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 7, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 14, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2030

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 23, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 23, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 30, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 14, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 13, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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