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Clinical Trials in the UK / NCT07094516
Recruiting Phase 2

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

NCT07094516 · tracked via the Priya Life Science UK tracker
Sponsor
Novartis Pharmaceuticals
Phase
Phase 2
Started
2025-08-07
Last updated
2026-06-26

Condition(s) studied

Alzheimer's Disease

Investigational drug(s) / intervention(s)

VHB937VHB937Placebo

VHB937: VHB937 solution for infusion

VHB937: VHB937 solution for infusion

Placebo: Solution for infusion

Study 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.

Eligibility

Sex
ALL
Min age
50 Years
Max age
85 Years
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (74)

FacilityCityRegionStatus
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 Recruiting
Novartis Investigative Site Kogarah New South Wales Recruiting
Novartis Investigative Site Box Hill Victoria Recruiting
Novartis Investigative Site Heidelberg Victoria Recruiting
Novartis Investigative Site Nedlands Western Australia Recruiting
Novartis Investigative Site London Ontario Recruiting
Novartis Investigative Site North York Ontario Recruiting
Novartis Investigative Site Ottawa Ontario Recruiting
Novartis Investigative Site Toronto Ontario Recruiting
Novartis Investigative Site Toronto Ontario Recruiting
Novartis Investigative Site Hangzhou Zhejiang 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 Recruiting
Novartis Investigative Site Paris France Recruiting

+ 34 more sites — see the full list on the official registry below.

More Novartis Pharmaceuticals trials in the UK

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07094516 on ClinicalTrials.gov ↗ ← All trials in the UK