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

Novartis

Status and phase: Enrolling; Phase 2

Conditions: Alzheimer's Disease

Treatments: Biological: VHB937; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT07094516

CVHB937A12201

Details and patient eligibility

About

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.

Full 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.

Enrollment: 407 estimated patients

Sex: All

Ages: 50 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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407 participants in 3 patient groups, including a placebo group

VHB937 Low Dose

Experimental group

Description:

I.V. infusions

Treatment:

Biological: VHB937

Biological: VHB937

VHB937 High Dose

Experimental group

Description:

I.V. infusions

Treatment:

Biological: VHB937

Biological: VHB937

Placebo

Placebo Comparator group

Description:

I.V. infusions

Treatment:

Other: Placebo