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Набира участници Фаза 2 NCT07094516

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

Фаза 2 – изследване на ефективността и дозировката
Заболявания: Alzheimer's Disease

Спонсор: Novartis Pharmaceuticals

Налично на: БГ
Обобщение
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.
Описание
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.
Кой може да участва
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
Места на провеждане 12
Австралия (1)
Novartis Investigative Site
Camperdown , New South Wales
Канада (1)
Novartis Investigative Site
North York , Ontario
Чехия (1)
Novartis Investigative Site
Brno
Франция (1)
Novartis Investigative Site
Toulouse , Haute Garonne
Германия (1)
Novartis Investigative Site
Berlin
Япония (1)
Novartis Investigative Site
Itabashi Ku , Tokyo
Нидерландия (1)
Novartis Investigative Site
Amsterdam
Полша (1)
Novartis Investigative Site
Bialystok
Южна Корея (1)
Novartis Investigative Site
Seoul , Korea
Швеция (1)
Novartis Investigative Site
Mölndal
Великобритания (1)
Novartis Investigative Site
Aberdeen
САЩ (1)
Banner Alzheimers Institute
Phoenix , Arizona
Технически детайли
Статус
Набира участници
Фаза
Фаза 2
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
50 Years
Максимална възраст
85 Years
Здрави доброволци
Не
Начална дата
07.08.2025
Крайна дата
31.12.2030
Регистрационен номер
NCT07094516
Източник
anzctr
Запитване за медицински туризъм

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