Recruiting NCT07094516
A Clinical Trial to Learn About the Effects of VHB937 in People With Early Alzheimer's Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: VHB937, VHB937, Placebo.
- Who it may be relevant to
- Registry conditions: Alzheimer's Disease. Basic parameters: 50 years — 85 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Australia, Canada, China, Czechia +10
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
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.
Detailed 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.
Interventions
- Biological VHB937
VHB937 solution for infusion - Biological VHB937
VHB937 solution for infusion - Other Placebo
Solution for infusion
Primary outcome measures
- Change from Baseline in the Clinical Dementia Rating scale - Sum of Boxes (CDR-SB) [Time frame: Baseline and Week 72]
Secondary outcome measures (8)
- Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs) [Time frame: 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) [Time frame: Baseline over time until Week 72]
- Change from Baseline in Alzheimer's Disease Assessment Scale-Cognitive (ADAS-Cog14) [Time frame: 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 [Time frame: Baseline over time until Week 72]
- Pharmacokinetic parameters of VHB937 in serum - Cmax [Time frame: Baseline over time until Week 72]
- Pharmacokinetic parameters of VHB937 in serum - Tmax [Time frame: Baseline over time until Week 72]
- Pharmacokinetic parameters of VHB937 in serum - Ctrough [Time frame: Baseline over time until Week 72]
- VHB937 immunogenicity in serum [Time frame: Baseline over time until Week 72]
Eligibility criteria
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
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
United States · 24 centers
- 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
- … and 16 more centers
United Kingdom · 9 centers
- 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
- … and 1 more center
South Korea · 6 centers
- Novartis Investigative Site — Seoul
- Novartis Investigative Site — Seoul
- Novartis Investigative Site — Seoul
- Novartis Investigative Site — Incheon
- Novartis Investigative Site — Incheon
- Novartis Investigative Site — Seoul
Australia · 5 centers
- Novartis Investigative Site — Camperdown
- Novartis Investigative Site — Kogarah
- Novartis Investigative Site — Box Hill
- Novartis Investigative Site — Heidelberg
- Novartis Investigative Site — Nedlands
Canada · 5 centers
- Novartis Investigative Site — London
- Novartis Investigative Site — North York
- Novartis Investigative Site — Ottawa
- Novartis Investigative Site — Toronto
- Novartis Investigative Site — Toronto
Japan · 5 centers
- Novartis Investigative Site — Ōbu
- Novartis Investigative Site — Fujioka
- Novartis Investigative Site — Itabashi Ku
- Novartis Investigative Site — Kodaira
- Novartis Investigative Site — Shinjuku Ku
Germany · 3 centers
- Novartis Investigative Site — Berlin
- Novartis Investigative Site — Berlin
- Novartis Investigative Site — München
Poland · 3 centers
- Novartis Investigative Site — Bialystok
- Novartis Investigative Site — Oświęcim
- Novartis Investigative Site — Wroclaw
Spain · 3 centers
- Novartis Investigative Site — Pamplona
- Novartis Investigative Site — Valencia
- Novartis Investigative Site — Valencia
China · 2 centers
- Novartis Investigative Site — Hangzhou
- Novartis Investigative Site — Shanghai
Czechia · 2 centers
- Novartis Investigative Site — Brno
- Novartis Investigative Site — Prague
France · 2 centers
- Novartis Investigative Site — Toulouse
- Novartis Investigative Site — Paris
Italy · 2 centers
- Novartis Investigative Site — Cefalù
- Novartis Investigative Site — Perugia
Sweden · 2 centers
- Novartis Investigative Site — Mölndal
- Novartis Investigative Site — Stockholm
Netherlands · 1 center
- Novartis Investigative Site — Amsterdam
Identifiers
NCT: NCT07094516 · CVHB937A12201