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RecruitingPhase 2

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
50 Years to 85 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests how well VHB937 works and how safe it is for people ages 50 to 85 with early Alzheimer's disease. It compares VHB937 with a placebo, a treatment with no active drug, for 72 weeks, followed by an added study period.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are 50 to 85 years old.
  • You have mild Alzheimer's disease or mild problems with memory and thinking caused by Alzheimer's.
  • Your score on the Clinical Dementia Rating scale, which rates memory and daily function, is 0.5 or 1.0.
  • Alzheimer's is confirmed by testing fluid around the brain and spinal cord or by a brain scan for amyloid, a protein linked to Alzheimer's.
  • You have a reliable study partner who can come with you to study visits.
  • If you take Alzheimer's symptom medicines, such as AChEIs or memantine, your dose is stable before study treatment starts.

Who can't join

  • Your dementia is caused by a condition other than Alzheimer's.
  • You have a history of heart problems or heart test results that pose a major safety risk.
  • You had a stroke or a TIA, sometimes called a mini-stroke, within the past 12 months.
  • You have signs of liver or kidney disease or injury.
  • You have major depression that is not well controlled, a history of schizophrenia, or another long-term illness that affects your sense of reality.
  • You have another serious brain or nerve condition, such as a serious brain infection, brain injury, multiple concussions, epilepsy, or repeated seizures.
  • You had thoughts of suicide within 6 months or suicidal behavior within 2 years before screening.
  • You have cancer, HIV, hepatitis B or C, poorly controlled thyroid disease or diabetes, or take medicines not allowed in the study.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility 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 sites (24)

AZ

  • Banner Alzheimers Institute · Phoenix, AZ 85006Allison Perrin · Principal investigatorMore trials in Phoenix

CA

FL

HI

KS

MA

MO

NC

NV

OH

OR

PA

TX

WA

  • University of Washington Medical Center · Seattle, WA 98195Michael Rosenbloom · Principal investigatorMore trials in Seattle