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Clinical trial · NCT07094516 · RECRUITING · PHASE2

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

Sponsor: Novartis Pharmaceuticals

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Summary

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.

Interventions

  • VHB937 · BIOLOGICAL

    VHB937 solution for infusion

  • VHB937 · BIOLOGICAL

    VHB937 solution for infusion

  • Placebo · OTHER

    Solution for infusion

Published eligibility criteria

Verbatim from the registry. Only the site can decide how these apply to a specific patient.

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

Sites (74)

  • Banner Alzheimers Institute, Phoenix, Arizona · RECRUITING
  • Irvine Center for Clinical Research, Irvine, California · RECRUITING
  • University of California San Diego, La Jolla, California · RECRUITING
  • University of California at Los Angeles, Los Angeles, California · RECRUITING
  • Jem Research Institute, Atlantis, Florida · RECRUITING
  • Visionary Investigators Network, Aventura, Florida · RECRUITING
  • K2 Medical Research LLC, Maitland, Florida · RECRUITING
  • K2 Medical Research LLC, Maitland, Florida · RECRUITING
  • Renstar Medical Research, Ocala, Florida · RECRUITING
  • Charter Research The Villages, The Villages, Florida · RECRUITING
  • Alzheimers Research Treatment Ctr, Wellington, Florida · RECRUITING
  • Alzheimers Research Treatment Ctr, Wellington, Florida · RECRUITING
  • Conquest Research, Winter Park, Florida · RECRUITING
  • Hawaii Pacific Neuroscience LLC, Honolulu, Hawaii · RECRUITING
  • University of Kansas Hospital, Fairway, Kansas · RECRUITING
  • ActivMed Practices and Research, Methuen, Massachusetts · RECRUITING
  • Citizens Memorial Hospital Neurology CLinic, Bolivar, Missouri · RECRUITING
  • Lou Ruvo Center for Brain Health, Las Vegas, Nevada · RECRUITING
  • UNC Hosp Invest Drug Serv Pharm, Chapel Hill, North Carolina · RECRUITING
  • The Ohio State University, Columbus, Ohio · RECRUITING
  • Neural Net Research, Portland, Oregon · RECRUITING
  • Abington Neurological Associates Ltd, Willow Grove, Pennsylvania · RECRUITING
  • University of Texas Health Science Center at San Antonio, San Antonio, Texas · RECRUITING
  • University of Washington Medical Center, Seattle, Washington · RECRUITING
  • Novartis Investigative Site, Camperdown, New South Wales, Australia · RECRUITING
  • Novartis Investigative Site, Kogarah, New South Wales, Australia · RECRUITING
  • Novartis Investigative Site, Box Hill, Victoria, Australia · RECRUITING
  • Novartis Investigative Site, Heidelberg, Victoria, Australia · RECRUITING
  • Novartis Investigative Site, Nedlands, Western Australia, Australia · RECRUITING
  • Novartis Investigative Site, London, Ontario, Canada · RECRUITING
  • Novartis Investigative Site, North York, Ontario, Canada · RECRUITING
  • Novartis Investigative Site, Ottawa, Ontario, Canada · RECRUITING
  • Novartis Investigative Site, Toronto, Ontario, Canada · RECRUITING
  • Novartis Investigative Site, Toronto, Ontario, Canada · RECRUITING
  • Novartis Investigative Site, Hangzhou, Zhejiang, China · RECRUITING
  • Novartis Investigative Site, Shanghai, China · RECRUITING
  • Novartis Investigative Site, Brno, Czechia · RECRUITING
  • Novartis Investigative Site, Prague, Czechia · RECRUITING
  • Novartis Investigative Site, Toulouse, Haute Garonne, France · RECRUITING
  • Novartis Investigative Site, Paris, France · RECRUITING
  • Novartis Investigative Site, Berlin, State of Berlin, Germany · RECRUITING
  • Novartis Investigative Site, Berlin, Germany · RECRUITING
  • Novartis Investigative Site, München, Germany · RECRUITING
  • Novartis Investigative Site, Cefalù, PA, Italy · RECRUITING
  • Novartis Investigative Site, Perugia, PG, Italy · RECRUITING
  • Novartis Investigative Site, Ōbu, Aichi-ken, Japan · RECRUITING
  • Novartis Investigative Site, Fujioka, Gunma, Japan · RECRUITING
  • Novartis Investigative Site, Itabashi Ku, Tokyo, Japan · RECRUITING
  • Novartis Investigative Site, Kodaira, Tokyo, Japan · RECRUITING
  • Novartis Investigative Site, Shinjuku Ku, Tokyo, Japan · RECRUITING
  • Novartis Investigative Site, Amsterdam, Netherlands · RECRUITING
  • Novartis Investigative Site, Bialystok, Poland · RECRUITING
  • Novartis Investigative Site, Oświęcim, Poland · RECRUITING
  • Novartis Investigative Site, Wroclaw, Poland · RECRUITING
  • Novartis Investigative Site, Seoul, Korea, South Korea · RECRUITING
  • Novartis Investigative Site, Seoul, Seoul, South Korea · RECRUITING
  • Novartis Investigative Site, Seoul, Seoul, South Korea · RECRUITING
  • Novartis Investigative Site, Incheon, South Korea · RECRUITING
  • Novartis Investigative Site, Incheon, South Korea · RECRUITING
  • Novartis Investigative Site, Seoul, South Korea · RECRUITING
  • Novartis Investigative Site, Pamplona, Navarre, Spain · RECRUITING
  • Novartis Investigative Site, Valencia, Valencia, Spain · RECRUITING
  • Novartis Investigative Site, Valencia, Spain · RECRUITING
  • Novartis Investigative Site, Mölndal, Sweden · RECRUITING
  • Novartis Investigative Site, Stockholm, Sweden · RECRUITING
  • Novartis Investigative Site, Edinburgh, Lothian, United Kingdom · RECRUITING
  • Novartis Investigative Site, Oxford, Oxfordshire, United Kingdom · RECRUITING
  • Novartis Investigative Site, Aberdeen, United Kingdom · RECRUITING
  • Novartis Investigative Site, London, United Kingdom · RECRUITING
  • Novartis Investigative Site, London, United Kingdom · RECRUITING
  • Novartis Investigative Site, London, United Kingdom · RECRUITING
  • Novartis Investigative Site, Newcastle upon Tyne, United Kingdom · RECRUITING
  • Novartis Investigative Site, Salford, United Kingdom · RECRUITING
  • Novartis Investigative Site, Southampton, United Kingdom · RECRUITING

Not medical advice. Trial0 is a navigation service, not a medical provider. Nothing here is medical advice or a recommendation to pursue any treatment; eligibility matching is informational, based on published registry criteria, and only the trial site or treating clinician can determine actual eligibility. Decisions belong with the patient and their own doctors. Registry data refreshed at most hourly; last update posted 2026-06-26.