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RECRUITINGPhase 2INTERVENTIONAL

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

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

BIOLOGICAL

VHB937

VHB937 solution for infusion

BIOLOGICAL

VHB937

VHB937 solution for infusion

OTHER

Placebo

Solution for infusion

Locations (20)

Banner Alzheimers Institute
Phoenix, Arizona, United States
University of California San Diego
La Jolla, California, United States
University of California at Los Angeles
Los Angeles, California, United States
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
Renstar Medical Research
Ocala, Florida, United States
Charter Research The Villages
The Villages, Florida, United States
Alzheimers Research Treatment Ctr
Wellington, Florida, United States
Alzheimers Research Treatment Ctr
Wellington, Florida, United States
Conquest Research
Winter Park, Florida, United States
Hawaii Pacific Neuroscience LLC
Honolulu, Hawaii, United States
University of Kansas Hospital
Fairway, Kansas, United States
ActivMed Practices and Research
Methuen, Massachusetts, United States
Citizens Memorial Hospital Neurology CLinic
Bolivar, Missouri, United States
UNC Hosp Invest Drug Serv Pharm
Chapel Hill, North Carolina, United States
The Ohio State University
Columbus, Ohio, United States
Neural Net Research
Portland, Oregon, United States
Abington Neurological Associates Ltd
Willow Grove, Pennsylvania, United States