Study Description
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. 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
Placebo
VHB937
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
Novartis Investigative Site
Recruiting
Camperdown,New South Wales,2050,Australia
Novartis Investigative Site
Recruiting
Kogarah,New South Wales,2217,Australia
Novartis Investigative Site
Recruiting
Box Hill,Victoria,3128,Australia
Novartis Investigative Site
Recruiting
North York,Ontario,M6a 2c8,Canada
Novartis Investigative Site
Recruiting
Toronto,Ontario,M3b 2s7,Canada
Novartis Investigative Site
Recruiting
Brno,602 00,Czechia
Novartis Investigative Site
Recruiting
Prague,160 00,Czechia
Novartis Investigative Site
Recruiting
Paris,75013,France
Novartis Investigative Site
Recruiting
Toulouse,Haute Garonne,31059,France
Novartis Investigative Site
Recruiting
Berlin,12200,Germany
Novartis Investigative Site
Recruiting
Berlin,13353,Germany
Novartis Investigative Site
Recruiting
München,80377,Germany
Novartis Investigative Site
Recruiting
Itabashi Ku,Tokyo,173 0015,Japan
Novartis Investigative Site
Recruiting
Kodaira,Tokyo,187-8551,Japan
Novartis Investigative Site
Recruiting
Shinjuku Ku,Tokyo,160-0023,Japan
Novartis Investigative Site
Recruiting
Amsterdam,1081 gn,Netherlands
Novartis Investigative Site
Recruiting
Bialystok,15-756,Poland
Novartis Investigative Site
Recruiting
Wroclaw,53659,Poland
Novartis Investigative Site
Recruiting
Seoul,Korea,03080,South Korea
Novartis Investigative Site
Recruiting
Seoul,Korea,05505,South Korea
Novartis Investigative Site
Recruiting
Incheon,21565,South Korea
Novartis Investigative Site
Recruiting
Incheon,22332,South Korea
Novartis Investigative Site
Recruiting
Seoul,04763,South Korea
Novartis Investigative Site
Recruiting
Seoul,05030,South Korea
Novartis Investigative Site
Recruiting
Mölndal,431 80,Sweden
Novartis Investigative Site
Recruiting
Stockholm,141 86,Sweden
Novartis Investigative Site
Recruiting
London,Wc1n 3bg,United Kingdom
Novartis Investigative Site
Recruiting
Aberdeen,Ab25 2zh,United Kingdom
Novartis Investigative Site
Recruiting
London,W1g 9jf,United Kingdom
Novartis Investigative Site
Recruiting
Southampton,So16 6yd,United Kingdom
University of Texas Health Science Center at San Antonio
Recruiting
San Antonio,Texas,78229-3900,United States
Sudha Seshadri
Alzheimers Research Treatment Ctr
Recruiting
Wellington,Florida,33414,United States
Adam Falchook
David Watson
Visionary Investigators Network
Recruiting
Aventura,Florida,33180,United States
Jonathan Cross
K2 Medical Research LLC
Recruiting
Maitland,Florida,32751,United States
Craig Curtis
Sheila Baez Torres
Charter Research The Villages
Recruiting
The Villages,Florida,32162,United States
Jeffrey Norton
ActivMed Practices and Research
Recruiting
Methuen,Massachusetts,01844,United States
Deborah Green-LaRoche
Abington Neurological Associates Ltd
Recruiting
Willow Grove,Pennsylvania,19090,United States
David Weisman
Banner Alzheimers Institute
Recruiting
Phoenix,Arizona,85006,United States
Allison Perrin
University of California San Diego
Recruiting
La Jolla,California,92037,United States
Gabriel Leger
University of California at Los Angeles
Recruiting
Los Angeles,California,90095,United States
Marie Kim
Renstar Medical Research
Recruiting
Ocala,Florida,34471,United States
Anette Veronica Nieves
University of Washington Medical Center
Recruiting
Seattle,Washington,98195,United States
Michael Rosenbloom
Conquest Research
Recruiting
Winter Park,Florida,32789,United States
Malisa Agard
Hawaii Pacific Neuroscience LLC
Recruiting
Honolulu,Hawaii,96817,United States
Kore Liow
University of Kansas Hospital
Recruiting
Fairway,Kansas,66205,United States
Townley Ryan
Citizens Memorial Hospital Neurology CLinic
Recruiting
Bolivar,Missouri,65613,United States
Curtis Schreiber
UNC Hosp Invest Drug Serv Pharm
Recruiting
Chapel Hill,North Carolina,27514,United States
Andrea Bozoki
The Ohio State University
Recruiting
Columbus,Ohio,43210,United States
Douglas W Scharre
Neural Net Research
Recruiting
Portland,Oregon,97225,United States
Michael S Mega
Worldwide Contacts
If the location of your choosing does not feature any contact detail, please reach out using the information below.