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

Официальное название

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

Обзор

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.

Подробное 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.

Вмешательства

• Биопрепарат VHB937
  VHB937 solution for infusion
• Биопрепарат VHB937
  VHB937 solution for infusion
• Другое Placebo
  Solution for infusion

Первичные конечные точки

• Change from Baseline in the Clinical Dementia Rating scale - Sum of Boxes (CDR-SB) [Срок оценки: Baseline and Week 72]

Вторичные конечные точки (8)

• Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs) [Срок оценки: From First treatment to end of study (up to 63 months approximately)]
• Change from Baseline in Clinical Dementia Rating scale - Sum of Boxes (CDR-SB) [Срок оценки: Baseline over time until Week 72]
• Change from Baseline in Alzheimer's Disease Assessment Scale-Cognitive (ADAS-Cog14) [Срок оценки: Baseline over time until Week 72]
• Change from Baseline in instrumental activities of daily living (iADL) on the Alzheimers Disease Cooperative Study - Activities of Daily Living (ADCS-ADL) scale [Срок оценки: Baseline over time until Week 72]
• Pharmacokinetic parameters of VHB937 in serum - Cmax [Срок оценки: Baseline over time until Week 72]
• Pharmacokinetic parameters of VHB937 in serum - Tmax [Срок оценки: Baseline over time until Week 72]
• Pharmacokinetic parameters of VHB937 in serum - Ctrough [Срок оценки: Baseline over time until Week 72]
• VHB937 immunogenicity in serum [Срок оценки: Baseline over time until Week 72]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

США · 24 центра

• Banner Alzheimers Institute — Phoenix
• Irvine Center for Clinical Research — Irvine
• University of California San Diego — La Jolla
• University of California at Los Angeles — Los Angeles
• Jem Research Institute — Atlantis
• Visionary Investigators Network — Aventura
• K2 Medical Research LLC — Maitland
• K2 Medical Research LLC — Maitland
• … и ещё 16 центров

Великобритания · 9 центров

• Novartis Investigative Site — Edinburgh
• Novartis Investigative Site — Oxford
• Novartis Investigative Site — Aberdeen
• Novartis Investigative Site — London
• Novartis Investigative Site — London
• Novartis Investigative Site — London
• Novartis Investigative Site — Newcastle upon Tyne
• Novartis Investigative Site — Salford
• … и ещё 1 центр

South Korea · 6 центров

• Novartis Investigative Site — Seoul
• Novartis Investigative Site — Seoul
• Novartis Investigative Site — Seoul
• Novartis Investigative Site — Incheon
• Novartis Investigative Site — Incheon
• Novartis Investigative Site — Seoul

Австралия · 5 центров

• Novartis Investigative Site — Camperdown
• Novartis Investigative Site — Kogarah
• Novartis Investigative Site — Box Hill
• Novartis Investigative Site — Heidelberg
• Novartis Investigative Site — Nedlands

Канада · 5 центров

• Novartis Investigative Site — London
• Novartis Investigative Site — North York
• Novartis Investigative Site — Ottawa
• Novartis Investigative Site — Toronto
• Novartis Investigative Site — Toronto

Япония · 5 центров

• Novartis Investigative Site — Ōbu
• Novartis Investigative Site — Fujioka
• Novartis Investigative Site — Itabashi Ku
• Novartis Investigative Site — Kodaira
• Novartis Investigative Site — Shinjuku Ku

Германия · 3 центра

• Novartis Investigative Site — Berlin
• Novartis Investigative Site — Berlin
• Novartis Investigative Site — München

Польша · 3 центра

• Novartis Investigative Site — Bialystok
• Novartis Investigative Site — Oświęcim
• Novartis Investigative Site — Wroclaw

Испания · 3 центра

• Novartis Investigative Site — Pamplona
• Novartis Investigative Site — Valencia
• Novartis Investigative Site — Valencia

Китай · 2 центра

• Novartis Investigative Site — Ханчжоу
• Novartis Investigative Site — Шанхай

Чехия · 2 центра

• Novartis Investigative Site — Brno
• Novartis Investigative Site — Prague

Франция · 2 центра

• Novartis Investigative Site — Toulouse
• Novartis Investigative Site — Paris

Италия · 2 центра

• Novartis Investigative Site — Cefalù
• Novartis Investigative Site — Perugia

Швеция · 2 центра

• Novartis Investigative Site — Mölndal
• Novartis Investigative Site — Stockholm

Нидерланды · 1 центр

• Novartis Investigative Site — Amsterdam

Идентификаторы

NCT: NCT07094516 · CVHB937A12201

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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