Clinical trial • Phase II • Neurology

VHB937 for Alzheimer's disease

Phase II trial of VHB937 for Alzheimer's disease.

Overview

Trial Therapeutic Area
Neurology
Trial Disease
Alzheimer's disease
Trial Stage
Phase II
Drug Modality
Monoclonal antibody

Key dates

Initial CTIS Submission Date
10-04-2025
First CTIS Authorization Date
04-08-2025

Trial design

Randomised, placebo: '00 mg/ml concentrate for solution for infusion' (placebo control, intravenous). comparator arm is placebo versus active vhb937 (intravenous). dose and schedule not specified in the available summary. Phase II trial in Czechia, Italy, Netherlands and others.

Randomised
Yes
Comparator
Placebo: '00 mg/mL Concentrate for solution for infusion' (placebo control, intravenous). Comparator arm is placebo versus active VHB937 (intravenous). Dose and schedule not specified in the available summary.
Target Sample Size
240
Trial Duration For Participant
504

Eligibility

Recruits 240 Participants are people with mild cognitive impairment or mild Alzheimer’s disease. A reliable study partner is required to accompany participants to visits where informant scales are administered. Study Partner ICFs and Study Partner Assent documents are present in the submission (study partner information materials and ICFs are listed among submitted documents). Informed consent is required from participants (main ICFs present); additional assent/partner documentation is provided for study partners..

Vulnerable Population
Participants are people with mild cognitive impairment or mild Alzheimer’s disease. A reliable study partner is required to accompany participants to visits where informant scales are administered. Study Partner ICFs and Study Partner Assent documents are present in the submission (study partner information materials and ICFs are listed among submitted documents). Informed consent is required from participants (main ICFs present); additional assent/partner documentation is provided for study partners.

Inclusion criteria

  • {"criterion_text":"- Male and female participants 50 to 85 years of age, with a maximum body weight of 180 kg at the time of signing the informed consent.\n- Diagnosis of Mild Cognitive Impairment (MCI) due to AD or mild AD according to the NIA-AA criteria (Jack et al 2018) at Screening.\n- Clinical Dementia Rating (CDR) Global score of 0.5 or 1.0 at Screening and Baseline.\n- ADAS-Cog14 total score between CCI at Screening.\n- Biomarker-based confirmation of Alzheimer disease (AD) at Screening based on cerebral spinal fluid (CSF) biomarkers or amyloid PET imaging. Historical confirmation of amyloid positivity by CSF or PET is accepted.\n- Reliable study partner who can accompany the participant at study visits in which informant scales are administered.\n- Participants receiving an AChEI or memantine or both for AD must be on a stable dose for at least 12 weeks before Randomization. For participants who discontinued these medications before Screening, the stop date should be at least 12 weeks before Randomization. Treatment-naïve participants can be enrolled into the study."}

Exclusion criteria

  • {"criterion_text":"- Dementia due to a condition other than AD including, but not limited to, frontal temporal dementia (FTD), Parkinson's disease, dementia with Lewy bodies, Huntington disease, vascular dementia.\n- Transient ischemic attacks (TIA) or stroke occurring within 12 months prior to randomization.\n- MRI evidence of more than CCI; any area of superficial siderosis; evidence of vasogenic edema; evidence of cerebral contusion, encephalomalacia, aneurysms, or infective lesions; evidence of multiple (≥ 2) lacunar infarcts irrespective of location or stroke involving a major vascular territory, severe small vessel, or white matter disease; space occupying lesions; or brain tumors (however, lesions diagnosed as meningiomas or arachnoid cysts and less than 1 cm at their greatest diameter need not be exclusionary).\n- Uncontrolled thyroid disease or uncontrolled diabetes or clinically significant laboratory abnormalities for thyroid function or fasting glucose in central laboratory results at Screening, as assessed by Investigator. The Investigator should ensure that the diabetic participants remain adequately controlled during the study.\n- Clinical evidence of liver disease or liver injury (other than hepatitis specified above) defined by any of the following results in central laboratory at Screening: ·\tTotal bilirubin > 1.5 x ULN, ·\tAlkaline phosphatase (ALP) > 3 x ULN, ·\tAST (SGOT) or ALT (SGPT) > 3 x ULN, and ·\tGamma-glutamyl-transferase (GGT) > 3 x ULN.\n- History or current diagnosis of cardiovascular conditions indicating significant risk of safety for participants in the study such as, but not limited to: ·\tMyocardial infarction or unstable angina (within 6 months of Screening), clinically significant cardiac arrhythmia (e.g., sustained ventricular tachycardia) requiring treatment and clinically significant second- or third-degree AV block without a pacemaker. ·\tFamilial long QT syndrome or known family history of Torsade de Pointe. ·\tResting QTcF ≥ 450 ms (male) or ≥ 460 ms (female) at Screening or inability to determine the QTcF interval\n- Severe renal impairment (Glomerular Filtration Rate < 30 mL/min/1.73 m2) in central laboratory results at Screening."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Change from Baseline to Week 72 in the Clinical Dementia Rating scale – Sum of Boxes (CDR-SB)","definition_or_measurement_approach":"Change from Baseline to Week 72 measured using the Clinical Dementia Rating scale – Sum of Boxes (CDR-SB) score (baseline and Week 72 assessments)."}

Secondary endpoints

  • {"endpoint_text":"- Incidence and severity of: ● Adverse events ● Safety findings from brain MRI (based on blinded independent central reading to assess abnormalities including ARIA events) ● Laboratory tests ● Vital signs ● ECG findings ●\tSuicidality assessment (Columbia Suicide Severity Rating Scale C-SSRS)","definition_or_measurement_approach":"Safety endpoints measured by adverse event reporting, central blinded MRI readings (including ARIA), laboratory tests, vital signs, ECG findings, and C-SSRS assessments."}
  • {"endpoint_text":"- Changes from Baseline in CDR-SB and ADAS-Cog14 over time until Week 72","definition_or_measurement_approach":"Efficacy measured as changes from baseline over time up to Week 72 in CDR-SB and ADAS-Cog14 scores."}
  • {"endpoint_text":"- Changes from Baseline in instrumental activities of daily living (iADL) on the ADCS-ADL scale over time until Week 72","definition_or_measurement_approach":"Measured as change from baseline on the ADCS-ADL (iADL) scale over time up to Week 72."}
  • {"endpoint_text":"- Pharmacokinetics: determination of VHB937 concentrations in serum at selected timepoints Immunogenicity: determination of anti-VHB937 antibodies in serum at selected timepoints","definition_or_measurement_approach":"Pharmacokinetics: serum VHB937 concentration measurements at predefined timepoints; Immunogenicity: measurement of anti-VHB937 antibodies in serum at predefined timepoints."}

Recruitment

Registry Or Advocacy Recruitment
True, Fundacio Ace Institut Catala De Neurociencies Aplicades
Digital Remote Recruitment
True, digital methods include Digital Patient Brochure, Website text, Link2Trials social media recruitment tools and other digital patient brochures available in multiple country-specific versions.
Planned Sample Size
240
Recruitment Window Months
68
Consent Approach
Informed consent is obtained from participating adults (participants aged 50–85). Main informed consent forms (ICFs) are provided; country-specific ICFs and subject information sheets are submitted (languages/countries include Czech, Italian, Polish, German, Dutch, Swedish, French, Spanish, English). Study Partner ICFs and Study Partner Assent/Assent Study Partner documents are included to address participant cognitive impairment and involvement of a reliable study partner. Optional additional research ICFs and pregnancy follow-up ICFs are also provided.

Methods

  • Digital Patient Brochure – electronic patient-facing brochure (digital materials submitted for multiple countries, e.g., Germany, Netherlands, Italy, Poland, France, Spain, Sweden, Czechia).
  • Doctor-to-Patient Letter – letters from physicians to patients (country-specific materials submitted, e.g., DE, IT, PL, FR, ES).
  • Patient Advocacy Group Letter – outreach to patient advocacy groups (documents named 'Patient Advocacy Group Letter' submitted for multiple countries).
  • Patient Brochure – printed patient brochure materials for distribution at sites (country versions present).
  • Patient Pre-Enrollment Information Card – brief cards for patient pre-enrollment (country-specific versions present).
  • Link2Trials / social media recruitment tools / Website text – digital recruitment via website and social media tools (documents 'Link2Trials social media recruitment tools' and website text present for Netherlands and other countries).
  • K1 Recruitment arrangements – formal recruitment arrangement documents submitted per country outlining recruitment procedures.

Geography

Total Number Of Sites
58
Total Number Of Participants
167

Czechia

Earliest CTIS Part Ii Submission Date
08-07-2025
Latest Decision Or Authorization Date
09-01-2026
Processing Time Days
185
Number Of Sites
5
Number Of Participants
14

Sites

Site Name
Neurohk s.r.o.
Contact Person Name
Martin Valis
Contact Person Email
valismar@seznam.cz
Site Name
Neuro Health Centrum s.r.o.
Contact Person Name
Katerina Sheardova
Contact Person Email
ksheardova@gmail.com
Site Name
Forbeli s.r.o.
Contact Person Name
Michal Bajacek
Contact Person Email
mbajacek@yahoo.co.uk
Site Name
Fakultni Nemocnice U Sv Anny V Brne
Department Name
I. neurologicka klinika
Contact Person Name
Lenka Krajcovicova
Contact Person Email
lenka.krajcovicova@fnusa.cz
Site Name
Fakultni Nemocnice Hradec Kralove
Department Name
Neurologicka klinika
Contact Person Name
Zbysek Pavelek
Contact Person Email
zbysekpavelek@email.cz

Italy

Earliest CTIS Part Ii Submission Date
15-07-2025
Latest Decision Or Authorization Date
12-01-2026
Processing Time Days
181
Number Of Sites
10
Number Of Participants
28

Sites

Site Name
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
Department Name
Neurologia
Contact Person Name
Alessandro Padovani
Contact Person Email
alessandro.padovani@unibs.it
Site Name
Fondazione IRCCS San Gerardo Dei Tintori
Department Name
Neurilogia
Contact Person Name
Carlo Ferrarese
Contact Person Email
carlo.ferrarese@unimib.it
Site Name
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Department Name
Neurologia
Contact Person Name
Camillo Marra
Site Name
Fondazione Istituto G. Giglio Di Cafalu
Department Name
Neurilogia
Contact Person Name
Luigi Grimaldi
Contact Person Email
luigi.grimaldi@hsrgiglio.it
Site Name
Hospital Santa Maria Della Misericordia
Department Name
Clinica Neurologica
Contact Person Name
Lucilla Parnetti
Contact Person Email
lucilla.parnetti@unipg.it
Site Name
Azienda USL Toscana Centro
Department Name
Neurologia 1
Contact Person Name
Valentina Bessi
Contact Person Email
valentina.bessi@unifi.it
Site Name
Azienda Ospedaliera Universitaria Universita' Degli Studi Della Campania Luigi Vanvitelli
Department Name
UOC Neurologia 1
Contact Person Name
Alessandro Tessitore
Site Name
Azienda Ospedaliera Universitaria San Giovanni Di Dio E Ruggi d'Aragona
Department Name
Neurologia
Contact Person Name
Paolo Barone
Contact Person Email
pbarone@unisa.it
Site Name
Pia Fondazione Di Culto E Religione Card G Panico
Department Name
UO Malattie Degenerative
Contact Person Name
Giancarlo Logroscino
Contact Person Email
giancarlo.logroscino@uniba.it
Site Name
Ospedale San Raffaele S.r.l.
Department Name
Neurologia
Contact Person Name
Massimo Filippi
Contact Person Email
filippi.massimo@hsr.it

Netherlands

Earliest CTIS Part Ii Submission Date
22-07-2025
Latest Decision Or Authorization Date
09-01-2026
Processing Time Days
171
Number Of Sites
3
Number Of Participants
12

Sites

Site Name
Brain Research Center Zwolle B.V.
Department Name
-
Contact Person Name
Lieza Exalto
Site Name
Brain Research Center Den Bosch B.V.
Department Name
-
Contact Person Name
Lieza Exalto
Site Name
Brain Research Center Amsterdam B.V.
Department Name
-
Contact Person Name
Lieza Exalto

Poland

Earliest CTIS Part Ii Submission Date
23-07-2025
Latest Decision Or Authorization Date
12-01-2026
Processing Time Days
173
Number Of Sites
7
Number Of Participants
25

Sites

Site Name
Etg Neuroscience Sp. z o.o.
Department Name
Ośrodek Badań Klinicznych
Contact Person Name
Aleksandra Karbowniczek
Site Name
Futuremeds Sp. z o.o.
Contact Person Name
Anatol Mickielewicz
Site Name
Revit Sp. z o.o.
Department Name
Podlaskie Centrum Psychogeriatrii
Contact Person Name
Jacek Dobryniewski
Contact Person Email
jacekdobryniewski@gmail.com
Site Name
Centrum Medyczne Neuroprotect
Contact Person Name
Mariusz Grudniak
Site Name
NZOZ Wrocławskie Centrum Alzheimerowskie
Contact Person Name
Marzena Zboch
Contact Person Email
zbochm@poczta.onet.pl
Site Name
Instytut Zdrowia Dr Boczarska-Jedynak Sp. z o.o. S.K.
Contact Person Name
Magdalena Boczarska-Jedynak
Site Name
Podlaskie Centrum Psychogeriatrii (Revit)
Contact Person Name
Jacek Dobryniewski
Contact Person Email
jacekdobryniewski@gmail.com

Germany

Earliest CTIS Part Ii Submission Date
07-07-2025
Latest Decision Or Authorization Date
16-01-2026
Processing Time Days
193
Number Of Sites
10
Number Of Participants
26

Sites

Site Name
Klinikum Bayreuth GmbH
Department Name
Klinik für Neurologie
Contact Person Name
Patrick Oschmann
Site Name
Katholisches Klinikum Bochum gGmbH
Department Name
Klinik für Neurologie
Contact Person Name
Siegfried Muhlack
Site Name
University Hospital Cologne AöR
Department Name
Klinik und Poliklinik für Neurologie
Contact Person Name
Franziska Maier
Contact Person Email
franziska.maier@uk-koeln.de
Site Name
Universitaetsklinikum Ulm AöR
Department Name
Neurologie
Contact Person Name
Doerte Polivka
Contact Person Email
doerte.polivka@uni-ulm.de
Site Name
LMU Klinikum Muenchen AöR
Department Name
Institut für Schlaganfall- und Demenzforschung
Contact Person Name
Katharina Buerger
Site Name
Charite Universitaetsmedizin Berlin KöR (Lindenberger Weg)
Department Name
Gedächtnissprechstunde am ECRC
Contact Person Name
Julian Hellmann Regen
Contact Person Email
julian.hellmann@charite.de
Site Name
Dynamikos GmbH Institut fuer Studien zur Psychischen Gesundheit
Department Name
ISPG
Contact Person Name
Georg Adler
Contact Person Email
adler@ispg-mannheim.de
Site Name
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum)
Department Name
Klinik und Poliklinik für Psychiatrie und Psychotherapie
Contact Person Name
Timo Grimmer
Contact Person Email
t.grimmer@tum.de
Site Name
Universitaet Muenster
Department Name
Klinik für Neurologie
Contact Person Name
Matthias Pawlowski
Site Name
Charite Universitaetsmedizin Berlin KöR (Hindenburgdamm)
Department Name
MVZ - Neurologie
Contact Person Name
Andreas Lueschow
Contact Person Email
andreas.lueschow@charite.de

France

Earliest CTIS Part Ii Submission Date
08-07-2025
Latest Decision Or Authorization Date
12-01-2026
Processing Time Days
188
Number Of Sites
8
Number Of Participants
22

Sites

Site Name
Assistance Publique Hopitaux De Paris
Department Name
Neurologie
Contact Person Name
Nicolas Villain
Contact Person Email
nicolas.villain@aphp.fr
Site Name
Hospices Civils De Lyon
Department Name
Neurologie
Contact Person Name
Sophie Dautricourt
Contact Person Email
sophie.dautricourt@chu-lyon.fr
Site Name
Centre Hospitalier Universitaire De Nantes
Department Name
Neurologie
Contact Person Name
Claire Boutoleau-Bretonniere
Site Name
Centre Hospitalier Regional De Marseille
Department Name
Neurologie
Contact Person Name
Mathieu Ceccaldi
Contact Person Email
mathieu.ceccaldi@ap-hm.fr
Site Name
Centre Hospitalier Universitaire De Lille
Department Name
Neurologie
Contact Person Name
Thibaud Lebouvier
Contact Person Email
thibaud.lebouvier@chu-lille.fr
Site Name
Centre Hospitalier Universitaire De Toulouse
Department Name
Neurologie
Contact Person Name
Pierre-Jean Ousset
Contact Person Email
ousset.pj@chu-toulouse.fr
Site Name
Centre Hospitalier Universitaire Rouen
Department Name
Neurologie
Contact Person Name
David Wallon
Contact Person Email
david.wallon@chu-rouen.fr
Site Name
Pellegrin Hospital
Department Name
Neurologie
Contact Person Name
Vincent Planche

Sweden

Earliest CTIS Part Ii Submission Date
19-06-2025
Latest Decision Or Authorization Date
09-01-2026
Processing Time Days
204
Number Of Sites
5
Number Of Participants
11

Sites

Site Name
Karolinska University Hospital
Department Name
Karolinska Universitetssjukhuset
Contact Person Name
Pia Andersen
Site Name
Region Skane Skanes Universitetssjukhus
Department Name
Skånes Universitetssjukhus
Contact Person Name
Henrik Östlund
Contact Person Email
henrik.ostlund@skane.se
Site Name
Region Oerebro Laen
Department Name
Örebro Universitetssjukhus
Contact Person Name
Yvonne Freund Levi
Contact Person Email
yvonne.freund@oru.se
Site Name
Sahlgrenska University Hospital-Vaestra Goetalandsregionen
Department Name
Sahlgrenska Universitetssjukhuset, Mölndal Sjukhus
Contact Person Name
Michael Jonsson
Contact Person Email
michael.jonsson@neuro.gu.se
Site Name
Uppsala University Hospital
Department Name
Akademiska Sjukhuset
Contact Person Name
Malin Löwenmark
Contact Person Email
malin.lowenmark@pubcare.uu.se

Spain

Earliest CTIS Part Ii Submission Date
26-06-2025
Latest Decision Or Authorization Date
13-01-2026
Processing Time Days
201
Number Of Sites
10
Number Of Participants
29

Sites

Site Name
Hospital Clinic De Barcelona
Department Name
Neurology
Contact Person Name
Neus Falgàs Martínez
Contact Person Email
nfalgas@clinic.cat
Site Name
Hospital Universitario Y Politecnico La Fe
Department Name
Neurology
Contact Person Name
Miquel Baquero Toledo
Contact Person Email
baquero_miq@gva.es
Site Name
University Hospital Virgen Del Rocio S.L.
Department Name
Neurology
Contact Person Name
Emilio Franco Macías
Contact Person Email
efranco17@gmail.com
Site Name
Hospital Universitario Reina Sofia
Department Name
Neurology
Contact Person Name
Eduardo Agüera Morales
Contact Person Email
doctoredu@gmail.com
Site Name
Hospital Universitari General De Catalunya
Department Name
Neurology
Contact Person Name
Ernest Balaguer Martínez
Contact Person Email
ebalaguer@quironsalud.es
Site Name
Hospital Universitario Ramon Y Cajal
Department Name
Neurology
Contact Person Name
Guillermo García Ribas
Contact Person Email
ggribas@salud.madrid.org
Site Name
Fundacio Ace Institut Catala De Neurociencies Aplicades
Department Name
Neurology
Contact Person Name
Mercè Boada Rovira
Contact Person Email
mboada@fundacioace.org
Site Name
Clinica Universidad De Navarra
Department Name
Neurology
Contact Person Name
Mario Riverol Fernández
Contact Person Email
mriverol@unav.es
Site Name
Hospital Universitario Dr Peset Aleixandre
Department Name
Neurology
Contact Person Name
Lamberto Landete Pascual
Contact Person Email
landete_lam@gva.es
Site Name
Policlinica Gipuzkoa S.A.
Department Name
Neurology
Contact Person Name
Gurutz Linazasoro Cristóbal
Contact Person Email
glinazasoro@vivebiotech.com

Sponsor

Primary sponsor

Full Name
Novartis Pharma AG
Organisation Type
Pharmaceutical company
Country Of Registered Address
Switzerland

Contract research organisations

Name
IQVIA Limited
Responsibilities
Central ECG, Regulatory Document Collection, IRB/Ethic Committee Submissions, Site Identification and Selection, Investigator Payments, Local ICF Development, Patient Recruitment, Trial Master File.
Name
Parexel International (IRL) Limited
Responsibilities
Duties listed under sponsor third parties (code 12) - role listed in submission (responsibility code present in sponsorDuties).
Name
Icon Clinical Research Limited
Responsibilities
Duties listed under sponsor third parties (code 4) - role listed in submission (responsibility code present in sponsorDuties).

Third parties

  • {"country":"United States","full_name":"Myonex LLC","duties_or_roles":"Ancillary supplies","organisation_type":"Hospital/Clinic/Other health care facility"}
  • {"country":"India","full_name":"Syngene International Limited","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"Central ECG, Regulatory Document Collection, IRB/Ethic Committee Submissions, Site Identification and Selection, Investigator Payments, Local ICF Development, Patient Recruitment, Trial Master File.","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"Medical Equipment Supplies And Management Limited","duties_or_roles":"Ancillary supplies","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"WCG Clinical Inc.","duties_or_roles":"Scale Management - Licensing, Development and Translation Activities, Virgil® Study Configuration (eCOA/ePRO)","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Bioclinica Inc.","duties_or_roles":"Imaging (PET scan and MRI)","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"Ireland","full_name":"Parexel International (IRL) Limited","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Greenphire LLC","duties_or_roles":"Concierge Service – Patient transportation - Reimbursement of patient expense","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
VHB937
Active Substance
VHB937
Modality
Monoclonal antibody
Routes Of Administration
Intravenous
Route
INTRAVENOUS
Investigational Product Name
00 mg/mL Concentrate for solution for infusion
Modality
Other

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