VHB937 Therapy for Early Alzheimer's Disease
This phase 2 study aims to evaluate the treatment VHB937 for early Alzheimer's disease, focusing on changes in cognitive and functional abilities using the Clinical Dementia Rating scale.
VHB937
+ Placebo
Alzheimer Disease+6
+ Mental Disorders
+ Brain Diseases
Treatment Study
Summary
Study start date: August 7, 2025
Actual date on which the first participant was enrolled.This study is focused on evaluating a new treatment called VHB937 for individuals in the early stages of Alzheimer's disease. The key aim is to determine if VHB937 is safe and can help improve memory and thinking skills, assist with daily activities, and influence changes in the brain associated with Alzheimer's. Understanding the effects of VHB937 is important because it could potentially offer a new way to manage symptoms and improve the quality of life for those affected by this condition. Participants in the study will receive VHB937, and researchers will monitor how it affects their memory, cognitive functions, and daily life abilities. The study involves closely observing how the body processes VHB937 and any responses it triggers. Researchers will collect data over a 72-week period to assess both the benefits and any possible risks associated with the treatment. This careful monitoring will help determine the overall safety and effectiveness of VHB937 for treating early Alzheimer's disease.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.407 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 50 to 85 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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 Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.3 intervention groups are designated in this study
33.333% chance of being blinded to the placebo group
Treatment Groups
Group I
ExperimentalGroup II
ExperimentalGroup III
PlaceboStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 9 locations
Visionary Investigators Network
Aventura, United StatesK2 Medical Research LLC
Maitland, United StatesK2 Medical Research LLC
Maitland, United States