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

NCT ID: NCT07094516

Last Updated: 2025-10-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

407 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-07

Study Completion Date

2030-12-31

Brief Summary

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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

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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.

Conditions

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Alzheimer's Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Double-blind, Randomized
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors
Blinded placebo for infusion

Study Groups

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VHB937 Low Dose

I.V. infusions

Group Type EXPERIMENTAL

VHB937

Intervention Type BIOLOGICAL

VHB937 solution for infusion

VHB937 High Dose

I.V. infusions

Group Type EXPERIMENTAL

VHB937

Intervention Type BIOLOGICAL

VHB937 solution for infusion

Placebo

I.V. infusions

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Solution for infusion

Interventions

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VHB937

VHB937 solution for infusion

Intervention Type BIOLOGICAL

VHB937

VHB937 solution for infusion

Intervention Type BIOLOGICAL

Placebo

Solution for infusion

Intervention Type OTHER

Eligibility Criteria

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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

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
Minimum Eligible Age

50 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Jem Research Institute

Atlantis, Florida, United States

Site Status RECRUITING

Visionary Investigators Network

Aventura, Florida, United States

Site Status RECRUITING

K2 Medical Research LLC

Maitland, Florida, United States

Site Status RECRUITING

K2 Medical Research LLC

Maitland, Florida, United States

Site Status RECRUITING

Charter Research The Villages

The Villages, Florida, United States

Site Status RECRUITING

ActivMed Practices and Research

Methuen, Massachusetts, United States

Site Status RECRUITING

Abington Neurological Associates Ltd

Willow Grove, Pennsylvania, United States

Site Status RECRUITING

Novartis Investigative Site

Toronto, Ontario, Canada

Site Status RECRUITING

Novartis Investigative Site

London, , United Kingdom

Site Status RECRUITING

Countries

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United States Canada United Kingdom

Central Contacts

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Novartis Pharmaceuticals

Role: CONTACT

1-888-669-6682

Novartis Pharmaceuticals

Role: CONTACT

+41613241111

Facility Contacts

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Role: primary

561-968-2933

Role: primary

978-462-9571

Role: primary

+1 215 957 9250 #57

Other Identifiers

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CVHB937A12201

Identifier Type: -

Identifier Source: org_study_id

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