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Recruiting Phase 2 NCT07094516

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

Phase 2 – studying effectiveness and dosage
Conditions: Alzheimer's Disease

Sponsor: Novartis Pharmaceuticals

trial.available_in: БГ
Overview
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.
Description
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.
Who can participate
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 12
Australia (1)
Novartis Investigative Site
Camperdown , New South Wales
Canada (1)
Novartis Investigative Site
North York , Ontario
Czech Republic (1)
Novartis Investigative Site
Brno
France (1)
Novartis Investigative Site
Toulouse , Haute Garonne
Germany (1)
Novartis Investigative Site
Berlin
Japan (1)
Novartis Investigative Site
Itabashi Ku , Tokyo
Netherlands (1)
Novartis Investigative Site
Amsterdam
Poland (1)
Novartis Investigative Site
Bialystok
South Korea (1)
Novartis Investigative Site
Seoul , Korea
Sweden (1)
Novartis Investigative Site
Mölndal
United Kingdom (1)
Novartis Investigative Site
Aberdeen
United States (1)
Banner Alzheimers Institute
Phoenix , Arizona
Technical details
Status
Recruiting
Phase
Phase 2
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
50 Years
Maximum age
85 Years
Healthy volunteers
No
Start date
07.08.2025
Completion date
31.12.2030
Registry ID
NCT07094516
Source
anzctr
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