Last Update: Oct 28, 2025
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
ClinicalTrials.gov Identifier:
Novartis Reference Number:CVHB937A12201
All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation.

Study Description

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. 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.

Alzheimer's Disease
Phase2
Recruiting
407
Aug 07, 2025
Dec 31, 2030
All
50 Years - 85 Years (Adult, Older Adult)

Interventions

Other

Placebo

Solution for infusion
Biological

VHB937

VHB937 solution for infusion

Eligibility 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

Novartis Investigative Site

Recruiting

Toronto,Ontario,M3b 2s7,Canada

Novartis Investigative Site

Recruiting

London,Wc1n 3bg,United Kingdom

Jem Research Institute

Recruiting

Atlantis,Florida,33462-6608,United States

Linda Pao

Visionary Investigators Network

Recruiting

Aventura,Florida,33180,United States

Jonathan Cross

K2 Medical Research LLC

Recruiting

Maitland,Florida,32751,United States

Craig Curtis
Sheila Baez Torres

Charter Research The Villages

Recruiting

The Villages,Florida,32162,United States

Jeffrey Norton

ActivMed Practices and Research

Recruiting

Methuen,Massachusetts,01844,United States

Deborah Green-LaRoche

Abington Neurological Associates Ltd

Recruiting

Willow Grove,Pennsylvania,19090,United States

David Weisman

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Novartis Pharmaceuticals

Novartis Pharmaceuticals