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

Purpose

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.

Condition

  • Alzheimer's Disease

Eligibility

Eligible Ages
Between 50 Years and 85 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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 Other protocol-defined inclusion/exclusion criteria may apply

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Double-blind, Randomized
Primary Purpose
Treatment
Masking
Triple (Participant, Investigator, Outcomes Assessor)
Masking Description
Blinded placebo for infusion

Arm Groups

ArmDescriptionAssigned Intervention
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

Recruiting Locations

University of Kansas Hospital
Fairway, Kansas 66205
Contact:
913-588-0555

More Details

Status
Recruiting
Sponsor
Novartis Pharmaceuticals

Study Contact

Novartis Pharmaceuticals
1-888-669-6682
novartis.email@novartis.com

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.