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

NCT07094516

RecruitingPhase 2

Sponsor: Novartis Pharmaceuticals

Conditions: Alzheimer's Disease

Interventions: VHB937, VHB937, Placebo

Countries: United States, Australia, Canada, China, Czechia, France, Germany, Italy

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.

Eligibility overview

Sex: ALL

Age: 50 Years to 85 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

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
Locations (74)
  • Phoenix, Arizona, United States
  • Irvine, California, United States
  • La Jolla, California, United States
  • Los Angeles, California, United States
  • Atlantis, Florida, United States
  • Aventura, Florida, United States
  • Maitland, Florida, United States
  • Maitland, Florida, United States
  • Ocala, Florida, United States
  • The Villages, Florida, United States
  • Wellington, Florida, United States
  • Wellington, Florida, United States
  • Winter Park, Florida, United States
  • Honolulu, Hawaii, United States
  • Fairway, Kansas, United States
  • Methuen, Massachusetts, United States
  • Bolivar, Missouri, United States
  • Las Vegas, Nevada, United States
  • Chapel Hill, North Carolina, United States
  • Columbus, Ohio, United States
  • Portland, Oregon, United States
  • Willow Grove, Pennsylvania, United States
  • San Antonio, Texas, United States
  • Seattle, Washington, United States
  • Camperdown, New South Wales, Australia
  • Kogarah, New South Wales, Australia
  • Box Hill, Victoria, Australia
  • Heidelberg, Victoria, Australia
  • Nedlands, Western Australia, Australia
  • London, Ontario, Canada
  • + 44 more on CT.gov