A Clinical Trial to Learn About the Effects of VHB937 in People With Early Alzheimer's Disease
NCT ID: NCT07094516
Last Updated: 2025-10-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
407 participants
INTERVENTIONAL
2025-08-07
2030-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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VHB937 Low Dose
I.V. infusions
VHB937
VHB937 solution for infusion
VHB937 High Dose
I.V. infusions
VHB937
VHB937 solution for infusion
Placebo
I.V. infusions
Placebo
Solution for infusion
Interventions
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VHB937
VHB937 solution for infusion
VHB937
VHB937 solution for infusion
Placebo
Solution for infusion
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
50 Years
85 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Locations
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Jem Research Institute
Atlantis, Florida, United States
Visionary Investigators Network
Aventura, Florida, United States
K2 Medical Research LLC
Maitland, Florida, United States
K2 Medical Research LLC
Maitland, Florida, United States
Charter Research The Villages
The Villages, Florida, United States
ActivMed Practices and Research
Methuen, Massachusetts, United States
Abington Neurological Associates Ltd
Willow Grove, Pennsylvania, United States
Novartis Investigative Site
Toronto, Ontario, Canada
Novartis Investigative Site
London, , United Kingdom
Countries
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Central Contacts
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Novartis Pharmaceuticals
Role: CONTACT
Facility Contacts
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Role: primary
Role: primary
Role: primary
Other Identifiers
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CVHB937A12201
Identifier Type: -
Identifier Source: org_study_id
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