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A Clinical Trial to Learn About the Effects of VHB937 in People With Early Alzheimer's Disease
NCT07094516 · Novartis
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
Official title
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
About this study
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.
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
Study design
Enrollment target: 407 participants
Allocation: randomized
Masking: triple
Age groups: adult, older_adult
Timeline
Starts: 2025-08-07
Estimated completion: 2030-12-31
Last updated: 2026-03-23
Interventions
Biological: VHB937Biological: VHB937Other: Placebo
Primary outcomes
- • Change from Baseline in the Clinical Dementia Rating scale - Sum of Boxes (CDR-SB) (Baseline and Week 72)
Sponsor
Novartis Pharmaceuticals · industry
Contacts & investigators
ContactNovartis Pharmaceuticals · contact · novartis.email@novartis.com · 1-888-669-6682
ContactNovartis Pharmaceuticals · contact · +41613241111
All locations (52)
Banner Alzheimers InstituteRecruiting
Phoenix, Arizona, United States
University of California San DiegoRecruiting
La Jolla, California, United States
University of California at Los AngelesRecruiting
Los Angeles, California, United States
Jem Research InstituteRecruiting
Atlantis, Florida, United States
Visionary Investigators NetworkRecruiting
Aventura, Florida, United States
K2 Medical Research LLCRecruiting
Maitland, Florida, United States
K2 Medical Research LLCRecruiting
Maitland, Florida, United States
Renstar Medical ResearchRecruiting
Ocala, Florida, United States
Charter Research The VillagesRecruiting
The Villages, Florida, United States
Alzheimers Research Treatment CtrRecruiting
Wellington, Florida, United States
Alzheimers Research Treatment CtrRecruiting
Wellington, Florida, United States
Conquest ResearchRecruiting
Winter Park, Florida, United States
Hawaii Pacific Neuroscience LLCRecruiting
Honolulu, Hawaii, United States
University of Kansas HospitalRecruiting
Fairway, Kansas, United States
ActivMed Practices and ResearchRecruiting
Methuen, Massachusetts, United States
Citizens Memorial Hospital Neurology CLinicRecruiting
Bolivar, Missouri, United States
UNC Hosp Invest Drug Serv PharmRecruiting
Chapel Hill, North Carolina, United States
The Ohio State UniversityRecruiting
Columbus, Ohio, United States
Neural Net ResearchRecruiting
Portland, Oregon, United States
Abington Neurological Associates LtdRecruiting
Willow Grove, Pennsylvania, United States
University of Texas Health Science Center at San AntonioRecruiting
San Antonio, Texas, United States
University of Washington Medical CenterRecruiting
Seattle, Washington, United States
Novartis Investigative SiteRecruiting
Camperdown, New South Wales, Australia
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Kogarah, New South Wales, Australia
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Box Hill, Victoria, Australia
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North York, Ontario, Canada
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Toronto, Ontario, Canada
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Brno, Czechia
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Prague, Czechia
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Toulouse, Haute Garonne, France
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Paris, France
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Berlin, Germany
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Berlin, Germany
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München, Germany
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Itabashi Ku, Tokyo, Japan
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Kodaira, Tokyo, Japan
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Shinjuku Ku, Tokyo, Japan
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Amsterdam, Netherlands
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Bialystok, Poland
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Wroclaw, Poland
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Seoul, Korea, South Korea
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Seoul, Korea, South Korea
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Incheon, South Korea
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Incheon, South Korea
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Seoul, South Korea
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Seoul, South Korea
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Mölndal, Sweden
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Stockholm, Sweden
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Aberdeen, United Kingdom
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London, United Kingdom
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London, United Kingdom
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Southampton, United Kingdom