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VHB937 Therapy for Early Alzheimer's Disease

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Study AimThis phase 2 study aims to evaluate the treatment VHB937 for early Alzheimer's disease, focusing on changes in cognitive and functional abilities using the Clinical Dementia Rating scale.
What is being tested

VHB937

+ VHB937
+ Placebo
Biological
Other
Who is being recruted

Alzheimer's Disease

From 50 to 85 Years

See all eligibility criteria

How is the trial designed

Treatment Study

Placebo-Controlled
Phase 2
Interventional
Study Start: August 2025

See protocol details

Summary

Principal SponsorNovartis Pharmaceuticals
Study ContactNovartis Pharmaceuticals
Last updated: October 28, 2025
Sourced from a government-validated database.Claim as a partner
Study start date: August 7, 2025Actual date on which the first participant was enrolled.

This study is focused on evaluating a new treatment called VHB937 for individuals in the early stages of Alzheimer's disease. The key aim is to determine if VHB937 is safe and can help improve memory and thinking skills, assist with daily activities, and influence changes in the brain associated with Alzheimer's. Understanding the effects of VHB937 is important because it could potentially offer a new way to manage symptoms and improve the quality of life for those affected by this condition. Participants in the study will receive VHB937, and researchers will monitor how it affects their memory, cognitive functions, and daily life abilities. The study involves closely observing how the body processes VHB937 and any responses it triggers. Researchers will collect data over a 72-week period to assess both the benefits and any possible risks associated with the treatment. This careful monitoring will help determine the overall safety and effectiveness of VHB937 for treating early Alzheimer's disease.

Official TitleA 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 
Principal SponsorNovartis Pharmaceuticals
Study ContactNovartis Pharmaceuticals
Last updated: October 28, 2025
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
407 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

How participants are assigned to different groups/arms
In this clinical study, participants are placed into groups randomly, like flipping a coin. This ensures that the study is fair and unbiased, making the results more reliable. By assigning participants by chance, researchers can better compare treatments without external influences.

Other Ways to Assign Participants
Non-randomized allocation: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.
None (Single-arm trial): If the study has only one group, all participants receive the same treatment, and no allocation is needed.

How treatments are given to participants
Participants are divided into different groups, each receiving a specific treatment at the same time. This helps researchers compare how well different treatments work against each other.

Other Ways to Assign Treatments
Single-group assignment: Everyone gets the same treatment.
Cross-over assignment: Participants switch between treatments during the study.
Factorial assignment: Participants receive different combinations of treatments.
Sequential assignment: Participants receive treatments one after another in a specific order, possibly based on individual responses.
Other assignment: Treatment assignment does not follow a standard or predefined design.

How the effectiveness of the treatment is controlled
In a placebo-controlled study, some participants receive the experimental treatment, while others receive an inert substance (placebo) to compare outcomes. This method helps to isolate the effect of the treatment from the psychological effects of receiving any treatment at all.

Other Options
Non-placebo-controlled: No placebo is used. All participants receive the actual treatment or alternative interventions (often the Standard of Care), and comparisons are made between these treatments.

How the interventions assigned to participants is kept confidential
Participants, researchers, and outcome assessors do not know which treatment is being given. This helps reduce bias not just during the study, but also when the results are being evaluated.

Other Ways to Mask Information
Open-label: Everyone knows which treatment is being given.
Single-blind: Participants do not know which treatment they are receiving, but researchers do.
Double-blind: Neither participants nor researchers know which treatment is given.
Quadruple-blind: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
From 50 to 85 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Alzheimer's Disease
Criteria

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

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives
3 intervention groups 

are designated in this study

33.333% chance 

of being blinded to the placebo group

Treatment Groups
Group I
Experimental
I.V. infusions
Group II
Experimental
I.V. infusions
Group III
Placebo
I.V. infusions
Study Objectives
Primary Objectives

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
Secondary Objectives

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.

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.

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

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

Cmax - The maximum concentration of VHB937 in serum

Tmax - The time to reach the maximum concentration of VHB937 in serum

Ctrough - Minimum observed concentration of VHB937 in CSF

Determination of anti-VHB937 antibodies in serum at selected timepoints

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 9 locations
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Jem Research InstituteAtlantis, United StatesSee the location
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Visionary Investigators NetworkAventura, United States
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K2 Medical Research LLCMaitland, United States
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K2 Medical Research LLCMaitland, United States
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9 Study Centers