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Active, not 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 USA tracker
Phase
Phase 2
Started
2025-08-07
Last updated
2026-10-21

Condition(s) studied

Alzheimer's Disease

Investigational drug(s) / intervention(s)

VHB937 →VHB937 →Placebo

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)

  • Change from Baseline in the Clinical Dementia Rating scale - Sum of Boxes (CDR-SB) — Baseline and Week 72
    The CDR is a measure of cognition and function, widely used in clinical research in AD. The scale assesses six domains: Memory, Orientation, Judgment \& Problem Solving, Community Affairs, Home \& Hobbies, and Personal Care. Based on in-depth semi-structured interview, each domain is assigned a score, which is summed to obtain the Sum of Boxes (SB) score, ranging from 0 to 18 with higher scores indicating worse condition

Trial sites (73)

FacilityCityRegionStatus
Banner Alzheimers Institute Phoenix Arizona
Irvine Center for Clinical Research Irvine California
University of California San Diego La Jolla California
University of California at Los Angeles Los Angeles California
Jem Research Institute Atlantis Florida
Visionary Investigators Network Aventura Florida
K2 Medical Research LLC Maitland Florida
Renstar Medical Research Ocala Florida
Charter Research The Villages The Villages Florida
Alzheimers Research Treatment Ctr Wellington Florida
Conquest Research Winter Park Florida
Hawaii Pacific Neuroscience LLC Honolulu Hawaii
University of Kansas Hospital Fairway Kansas
ActivMed Practices and Research Methuen Massachusetts
Citizens Memorial Hospital Neurology CLinic Bolivar Missouri
Lou Ruvo Center for Brain Health Las Vegas Nevada
UNC Hosp Invest Drug Serv Pharm Chapel Hill North Carolina
The Ohio State University Columbus Ohio
Neural Net Research Portland Oregon
Abington Neurological Associates Ltd Willow Grove Pennsylvania
University of Texas Health Science Center at San Antonio San Antonio Texas
University of Washington Medical Center Seattle Washington
Novartis Investigative Site Camperdown New South Wales
Novartis Investigative Site Kogarah New South Wales
Novartis Investigative Site Box Hill Victoria
Novartis Investigative Site Heidelberg Victoria
Novartis Investigative Site Nedlands Western Australia
Novartis Investigative Site London Ontario
Novartis Investigative Site North York Ontario
Novartis Investigative Site Ottawa Ontario
Novartis Investigative Site Toronto Ontario
Novartis Investigative Site Toronto Ontario
Novartis Investigative Site Hangzhou Zhejiang
Novartis Investigative Site Shanghai China
Novartis Investigative Site Brno Czechia
Novartis Investigative Site Prague Czechia
Novartis Investigative Site Toulouse Haute Garonne
Novartis Investigative Site Paris France
Novartis Investigative Site Berlin State of Berlin
Novartis Investigative Site Berlin Germany

+ 33 more sites — see the full list on the official registry below.

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 USA