This study is in progress, not accepting new patients

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

a study on Alzheimer's Disease Dementia

Summary

Eligibility
for people ages 50-85 (full criteria)
Location
at UCLA UCSD
Dates
study started
study ends around

Description

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.

Official Title

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

Details

The purpose of this study is to find out whether treatment with VHB937 is safe and beneficial in people with early Alzheimer's disease. The study will evaluate the safety of VHB937, as well as its effects on memory and other thinking abilities, on daily activities, and on changes in the brain. The study will also observe and measure how VHB937 is processed by the body and how the body responds to it.

Keywords

Alzheimer's Disease, AD, Dementia, Monoclonal Antibody, Alzheimer Disease, VHB937

Eligibility

You can join if…

Open to people ages 50-85

  • 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

You CAN'T join if...

  • 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

Locations

  • University of California San Diego
    La Jolla California 92037 United States
  • University of California at Los Angeles
    Los Angeles California 90095 United States
  • Irvine Center for Clinical Research
    Irvine California 92618 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Novartis Pharmaceuticals
ID
NCT07094516
Phase
Phase 2 research study
Study Type
Interventional
Participants
About 97 people participating
Last Updated