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
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Camperdown,New South Wales,2050,Australia
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Kogarah,New South Wales,2217,Australia
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Box Hill,Victoria,3128,Australia
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North York,Ontario,M6a 2c8,Canada
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London,Ontario,N6g 3h7,Canada
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Toronto,Ontario,M5t 2s8,Canada
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Toronto,Ontario,M3b 2s7,Canada
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Prague,160 00,Czechia
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Brno,602 00,Czechia
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Paris,75013,France
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Toulouse,Haute Garonne,31059,France
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Berlin,12200,Germany
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Berlin,13353,Germany
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München,80377,Germany
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Perugia,PG,06129,Italy
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Cefalù,PA,90015,Italy
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Itabashi Ku,Tokyo,1730015,Japan
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Kodaira,Tokyo,187-8551,Japan
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Shinjuku Ku,Tokyo,160-0023,Japan
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Amsterdam,1081 gn,Netherlands
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Oświęcim,32-600,Poland
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Bialystok,15-756,Poland
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Wroclaw,53659,Poland
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Seoul,04763,South Korea
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Seoul,Korea,05505,South Korea
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Incheon,21565,South Korea
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Incheon,22332,South Korea
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Seoul,05030,South Korea
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Seoul,03080,South Korea
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Pamplona,Navarre,31008,Spain
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Valencia,Valencia,46017,Spain
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Valencia,46026,Spain
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Mölndal,431 80,Sweden
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Stockholm,141 86,Sweden
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Newcastle upon Tyne,Ne4 6be,United Kingdom
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Aberdeen,Ab25 2zh,United Kingdom
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London,W1g 9jf,United Kingdom
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Southampton,So16 6yd,United Kingdom
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Edinburgh,Lothian,Eh12 5pj,United Kingdom
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London,Se5 8af,United Kingdom
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London,Wc1n 3bg,United Kingdom
Abington Neurological Associates Ltd
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Willow Grove,Pennsylvania,19090,United States
David Weisman
Irvine Center for Clinical Research
Recruiting
Irvine,California,92618,United States
Edward Zamrini
Lou Ruvo Center for Brain Health
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Las Vegas,Nevada,89106,United States
Charles Bernick
University of California San Diego
Recruiting
La Jolla,California,92037,United States
Gabriel Leger
Banner Alzheimers Institute
Recruiting
Phoenix,Arizona,85006,United States
Allison Perrin
University of California at Los Angeles
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Los Angeles,California,90095,United States
Marie Kim
ActivMed Practices and Research
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Methuen,Massachusetts,01844,United States
Deborah Green-LaRoche
Charter Research The Villages
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The Villages,Florida,32162,United States
Jeffrey Norton
K2 Medical Research LLC
Recruiting
Maitland,Florida,32751,United States
Sheila Baez Torres
Craig Curtis
Visionary Investigators Network
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Aventura,Florida,33180,United States
Jonathan Cross
University of Kansas Hospital
Recruiting
Fairway,Kansas,66205,United States
Townley Ryan
University of Texas Health Science Center at San Antonio
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San Antonio,Texas,78229-3900,United States
Sudha Seshadri
Neural Net Research
Recruiting
Portland,Oregon,97225,United States
Michael S Mega
The Ohio State University
Recruiting
Columbus,Ohio,43210,United States
Douglas W Scharre
UNC Hosp Invest Drug Serv Pharm
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Chapel Hill,North Carolina,27514,United States
Andrea Bozoki
Citizens Memorial Hospital Neurology CLinic
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Bolivar,Missouri,65613,United States
Curtis Schreiber
University of Washington Medical Center
Recruiting
Seattle,Washington,98195,United States
Michael Rosenbloom
Hawaii Pacific Neuroscience LLC
Recruiting
Honolulu,Hawaii,96817,United States
Kore Liow
Conquest Research
Recruiting
Winter Park,Florida,32789,United States
Malisa Agard
Alzheimers Research Treatment Ctr
Recruiting
Wellington,Florida,33414,United States
David Watson
Adam Falchook
Renstar Medical Research
Recruiting
Ocala,Florida,34471,United States
Anette Veronica Nieves
Worldwide Contacts
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