Last Update: Jun 26, 2026 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 ClinicalTrials.gov Identifier: [NCT07094516](https://clinicaltrials.gov/ct2/show/NCT07094516) Novartis Reference Number:CVHB937A12201 [See if you Pre-qualify](#trial-eligibility "See if you Pre-qualify") All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation. ## 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. Condition Alzheimer's Disease Phase Phase2 Overall Status Recruiting Number of Participants407 Start Date Aug 07, 2025 Completion Date Dec 31, 2030 Gender All Age(s) 50 Years - 85 Years (Adult, Older Adult) ## Interventions Other ### Placebo Solution for infusion Biological ### VHB937 VHB937 solution for infusion ## 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 Australia #### 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 Heidelberg,Victoria,3084,Australia #### Novartis Investigative Site Recruiting Nedlands,Western Australia,6009,Australia Canada #### Novartis Investigative Site Recruiting North York,Ontario,M6a 2c8,Canada #### Novartis Investigative Site Recruiting Toronto,Ontario,M5t 2s8,Canada #### Novartis Investigative Site Recruiting London,Ontario,N6g 3h7,Canada #### Novartis Investigative Site Recruiting Ottawa,Ontario,K1n 5c8,Canada #### Novartis Investigative Site Recruiting Toronto,Ontario,M3b 2s7,Canada China #### Novartis Investigative Site Recruiting Hangzhou,Zhejiang,310002,China #### Novartis Investigative Site Recruiting Shanghai,200040,China Czechia #### Novartis Investigative Site Recruiting Prague,160 00,Czechia #### Novartis Investigative Site Recruiting Brno,602 00,Czechia France #### Novartis Investigative Site Recruiting Toulouse,Haute Garonne,31059,France #### Novartis Investigative Site Recruiting Paris,75013,France Germany #### Novartis Investigative Site Recruiting München,80377,Germany #### Novartis Investigative Site Recruiting Berlin,13353,Germany #### Novartis Investigative Site Recruiting Berlin,State of Berlin,12200,Germany Italy #### Novartis Investigative Site Recruiting Perugia,PG,06129,Italy #### Novartis Investigative Site Recruiting Cefalù,PA,90015,Italy Japan #### Novartis Investigative Site Recruiting Itabashi Ku,Tokyo,1730015,Japan #### Novartis Investigative Site Recruiting Kodaira,Tokyo,187-8551,Japan #### Novartis Investigative Site Recruiting Shinjuku Ku,Tokyo,160-0023,Japan #### Novartis Investigative Site Recruiting Ōbu,Aichi-ken,4748511,Japan #### Novartis Investigative Site Recruiting Fujioka,Gunma,375-0017,Japan Netherlands #### Novartis Investigative Site Recruiting Amsterdam,1081 gn,Netherlands Poland #### Novartis Investigative Site Recruiting Oświęcim,32-600,Poland #### Novartis Investigative Site Recruiting Bialystok,15-756,Poland #### Novartis Investigative Site Recruiting Wroclaw,53659,Poland South Korea #### Novartis Investigative Site Recruiting Incheon,21565,South Korea #### Novartis Investigative Site Recruiting Seoul,Korea,05505,South Korea #### Novartis Investigative Site Recruiting Seoul,04763,South Korea #### Novartis Investigative Site Recruiting Seoul,Seoul,05030,South Korea #### Novartis Investigative Site Recruiting Seoul,Seoul,03080,South Korea #### Novartis Investigative Site Recruiting Incheon,22332,South Korea Spain #### Novartis Investigative Site Recruiting Valencia,Valencia,46017,Spain #### Novartis Investigative Site Recruiting Valencia,46026,Spain #### Novartis Investigative Site Recruiting Pamplona,Navarre,31008,Spain Sweden #### Novartis Investigative Site Recruiting Stockholm,141 86,Sweden #### Novartis Investigative Site Recruiting Mölndal,431 80,Sweden United Kingdom #### Novartis Investigative Site Recruiting Southampton,So16 6yd,United Kingdom #### Novartis Investigative Site Recruiting London,W1g 9jf,United Kingdom #### Novartis Investigative Site Recruiting Aberdeen,Ab25 2zh,United Kingdom #### Novartis Investigative Site Recruiting Edinburgh,Lothian,Eh12 5pj,United Kingdom #### Novartis Investigative Site Recruiting London,Se5 8af,United Kingdom #### Novartis Investigative Site Recruiting Newcastle upon Tyne,Ne4 6be,United Kingdom #### Novartis Investigative Site Recruiting Oxford,Oxfordshire,Ox3 7jx,United Kingdom #### Novartis Investigative Site Recruiting Salford,M6 8hd,United Kingdom #### Novartis Investigative Site Recruiting London,Wc1n 3bg,United Kingdom United States #### Abington Neurological Associates Ltd Recruiting Willow Grove,Pennsylvania,19090,United States Phone: [+1 215 957 9250 #57]() ###### David Weisman #### Alzheimers Research Treatment Ctr Recruiting Wellington,Florida,33414,United States Phone: [+1 561 209 2400]() ###### Adam Falchook ###### David Watson #### Renstar Medical Research Recruiting Ocala,Florida,34471,United States ###### Anette Veronica Nieves Phone: [+1 813 345 8210]() #### University of California at Los Angeles Recruiting Los Angeles,California,90095,United States ###### Marie Kim #### 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 #### ActivMed Practices and Research Recruiting Methuen,Massachusetts,01844,United States ###### Deborah Green-LaRoche Phone: [+1 978 462 9571]() #### Charter Research The Villages Recruiting 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 Recruiting Aventura,Florida,33180,United States ###### Jonathan Cross #### Jem Research Institute Recruiting Atlantis,Florida,33462-6608,United States ###### Linda Pao Phone: [+1 561 968 2933]() #### Lou Ruvo Center for Brain Health Recruiting Las Vegas,Nevada,89106,United States Phone: [+1 702 483 6025]() ###### Charles Bernick #### University of Texas Health Science Center at San Antonio Recruiting San Antonio,Texas,78229-3900,United States ###### Sudha Seshadri Phone: [+1 210 567 8229]() #### 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 Recruiting Chapel Hill,North Carolina,27514,United States ###### Andrea Bozoki #### Citizens Memorial Hospital Neurology CLinic Recruiting Bolivar,Missouri,65613,United States ###### Curtis Schreiber Phone: [+1 417 841 3643]() #### Irvine Center for Clinical Research Recruiting Irvine,California,92618,United States Phone: [+1 949 753 1663#208]() ###### Edward Zamrini #### University of Washington Medical Center Recruiting Seattle,Washington,98195,United States ###### Michael Rosenbloom #### University of Kansas Hospital Recruiting Fairway,Kansas,66205,United States ###### Townley Ryan Phone: [+1 913 588 0555]() #### Hawaii Pacific Neuroscience LLC Recruiting Honolulu,Hawaii,96817,United States ###### Kore Liow #### Conquest Research Recruiting Winter Park,Florida,32789,United States ###### Malisa Agard ## Worldwide Contacts If the location of your choosing does not feature any contact detail, please reach out using the information below. #### Novartis Pharmaceuticals Phone: [ +41613241111](tel:+41613241111) Email: [](mailto:) #### Novartis Pharmaceuticals Phone: [ 1-888-669-6682](tel:1-888-669-6682) Email: