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Phase 2Recruiting

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

Sponsored by Novartis Pharmaceuticals

About this study

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.

Where this study is enrolling (9)

  • Irvine Center for Clinical Research

    Irvine, California

    Call +1 949 753 1663#208

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  • Jem Research Institute

    Atlantis, Florida

    Call +1 561 968 2933

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  • Renstar Medical Research

    Ocala, Florida

    Call +1 813 345 8210

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  • University of Kansas Hospital

    Fairway, Kansas

    Call +1 913 588 0555

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  • ActivMed Practices and Research

    Methuen, Massachusetts

    Call +1 978 462 9571

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Show all 9 locations

  • Citizens Memorial Hospital Neurology CLinic

    Bolivar, Missouri

    Call +1 417 841 3643

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  • Lou Ruvo Center for Brain Health

    Las Vegas, Nevada

    Call +1 702 483 6025

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  • Abington Neurological Associates Ltd

    Willow Grove, Pennsylvania

    Call +1 215 957 9250 #57

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  • University of Texas Health Science Center at San Antonio

    San Antonio, Texas

    Call +1 210 567 8229

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Who can participate

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

Only the research team can confirm whether you qualify. The intake questionnaire is the best way to find out.

Completing a questionnaire on Clinably does not enroll you in a clinical trial or confirm your eligibility. Only the research team can determine whether you qualify to participate. These results are based on the information you provide and are intended to help you start a conversation with the research team.

Trial data sourced from ClinicalTrials.gov.