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

About

Brief 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.

Primary Purpose

Treatment

Study Type

Interventional

Phase

Phase 2

Eligibility

Gender

All

Healthy Volunteers

No

Minimum Age

50 Years

Maximum Age

85 Years

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