Alzheimer's DiseasePhase 2NCT07094516
A Clinical Trial to Learn About the Effects of VHB937 in People With Early Alzheimer's Disease
A Phase 2 study testing VHB937 in people with Alzheimer's Disease, run by Novartis Pharmaceuticals at 73 sites in 15 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Alzheimer's Disease
- What is being tested?
- VHB937
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 97 participants
- Where
- 73 sitesin 15 countries
- Study dates
- 7 Aug 2025to 31 Dec 2030
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
73 sites in 15 countries.
73 sites in 15 countries
United States22 sites
Jem Research Institute
Atlantis, Florida, 33462-6608
Visionary Investigators Network
Aventura, Florida, 33180
Citizens Memorial Hospital Neurology CLinic
Bolivar, Missouri, 65613
UNC Hosp Invest Drug Serv Pharm
Chapel Hill, North Carolina, 27514
The Ohio State University
Columbus, Ohio, 43210
University of Kansas Hospital
Fairway, Kansas, 66205
Hawaii Pacific Neuroscience LLC
Honolulu, Hawaii, 96817
Irvine Center for Clinical Research
Irvine, California, 92618
University of California San Diego
La Jolla, California, 92037
Lou Ruvo Center for Brain Health
Las Vegas, Nevada, 89106
University of California at Los Angeles
Los Angeles, California, 90095
K2 Medical Research LLC
Maitland, Florida, 32751
ActivMed Practices and Research
Methuen, Massachusetts, 01844
Renstar Medical Research
Ocala, Florida, 34470
Banner Alzheimers Institute
Phoenix, Arizona, 85006
Neural Net Research
Portland, Oregon, 97225
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229-3900
University of Washington Medical Center
Seattle, Washington, 98195
Charter Research The Villages
The Villages, Florida, 32162
Alzheimers Research Treatment Ctr
Wellington, Florida, 33414
Abington Neurological Associates Ltd
Willow Grove, Pennsylvania, 19090
Conquest Research
Winter Park, Florida, 32789
United Kingdom9 sites
Novartis Investigative Site
Aberdeen, AB25 2ZH
Novartis Investigative Site
Edinburgh, Lothian, EH12 5PJ
Novartis Investigative Site
London, SE5 8AF
Novartis Investigative Site
London, W1G 9JF
Novartis Investigative Site
London, WC1N 3BG
Novartis Investigative Site
Newcastle upon Tyne, NE4 6BE
Novartis Investigative Site
Oxford, Oxfordshire, OX3 7JX
Novartis Investigative Site
Salford, M6 8HD
Novartis Investigative Site
Southampton, SO16 6YD
South Korea6 sites
Novartis Investigative Site
Incheon, 21565
Novartis Investigative Site
Incheon, 22332
Novartis Investigative Site
Seoul, Korea, 05505
Novartis Investigative Site
Seoul, Seoul, 03080
Novartis Investigative Site
Seoul, Seoul, 05030
Novartis Investigative Site
Seoul, 04763
Australia5 sites
Novartis Investigative Site
Box Hill, Victoria, 3128
Novartis Investigative Site
Camperdown, New South Wales, 2050
Novartis Investigative Site
Heidelberg, Victoria, 3084
Novartis Investigative Site
Kogarah, New South Wales, 2217
Novartis Investigative Site
Nedlands, Western Australia, 6009
Canada5 sites
Novartis Investigative Site
London, Ontario, N6G 3H7
Novartis Investigative Site
North York, Ontario, M6A 2C8
Novartis Investigative Site
Ottawa, Ontario, K1N 5C8
Novartis Investigative Site
Toronto, Ontario, M3B 2S7
Novartis Investigative Site
Toronto, Ontario, M5T 2S8
Japan5 sites
Novartis Investigative Site
Fujioka, Gunma, 3750017
Novartis Investigative Site
Itabashi Ku, Tokyo, 1730015
Novartis Investigative Site
Kodaira, Tokyo, 1878551
Novartis Investigative Site
Ōbu, Aichi-ken, 4748511
Novartis Investigative Site
Shinjuku Ku, Tokyo, 1600023
Germany3 sites
Novartis Investigative Site
Berlin, State of Berlin, 12200
Novartis Investigative Site
Berlin, 13353
Novartis Investigative Site
München, 80377
Italy3 sites
Novartis Investigative Site
Cefalù, PA, 90015
Novartis Investigative Site
Milan, MI, 20132
Novartis Investigative Site
Perugia, PG, 06129
Poland3 sites
Novartis Investigative Site
Bialystok, 15-756
Novartis Investigative Site
Oświęcim, 32-600
Novartis Investigative Site
Wroclaw, 53-659
Spain3 sites
Novartis Investigative Site
Pamplona, Navarre, 31008
Novartis Investigative Site
Valencia, Valencia, 46017
Novartis Investigative Site
Valencia, 46026
China2 sites
Novartis Investigative Site
Hangzhou, Zhejiang, 310002
Novartis Investigative Site
Shanghai, 200040
Czechia2 sites
Novartis Investigative Site
Brno, 602 00
Novartis Investigative Site
Prague, 160 00
France2 sites
Novartis Investigative Site
Paris, 75013
Novartis Investigative Site
Toulouse, Haute Garonne, 31059
Sweden2 sites
Novartis Investigative Site
Mölndal, 431 80
Novartis Investigative Site
Stockholm, 141 86
About this study
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
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.
Read the 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.
- Conditions
- Alzheimer's Disease
- Being tested
- VHB937, Placebo
- Keywords
- Alzheimer's disease, AD, Dementia, Monoclonal Antibody
- Medical subject headings
- Alzheimer Disease, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VHB937Biological
VHB937 solution for infusion
VHB937Biological
VHB937 solution for infusion
PlaceboOther
Solution for infusion
| Study group | Role | What they receive |
|---|---|---|
| VHB937 Low Dose | Experimental | I.V. infusions Receives: Biological: VHB937 |
| VHB937 High Dose | Experimental | I.V. infusions Receives: Biological: VHB937 |
| Placebo | Placebo comparator | I.V. infusions Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in the Clinical Dementia Rating scale - Sum of Boxes (CDR-SB)
The CDR is a measure of cognition and function, widely used in clinical research in AD. The scale assesses six domains: Memory, Orientation, Judgment \& Problem Solving, Community Affairs, Home \& Hobbies, and Personal Care. Based on in-depth semi-structured interview, each domain is assigned a score, which is summed to obtain the Sum of Boxes (SB) score, ranging from 0 to 18 with higher scores indicating worse condition
Measured: Baseline and Week 72
Secondary outcomes (8)
Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Incidence and severity of AEs and SAEs by treatment group, including Safety findings, Laboratory tests, Vital signs and, ECG findings qualifying and reported as AEs.
Measured: 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)
The CDR is a measure of cognition and function, widely used in clinical research in AD. The scale assesses six domains: Memory, Orientation, Judgment \& Problem Solving, Community Affairs, Home \& Hobbies, and Personal Care.
Measured: Baseline over time until Week 72
Change from Baseline in Alzheimer's Disease Assessment Scale-Cognitive (ADAS-Cog14)
The ADAS-Cog is is a 14-item clinical assessment tool to measure cognition. The ADAS-Cog14 score ranges between 0 and 90, with higher scores indicating worse cognitive performance
Measured: 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
The ADCS-ADL is a 23-item study partner scale designed to assess the ability of patients with AD to carry out basic activities of daily living (bADLs) and instrumental activities of daily living (iADLs). For each item, the study partner is asked whether the participant attempted the activity in the 4 preceding weeks. Where 'yes' is the answer, the study partner is asked to rate the patient's level of performance according to a set of descriptors tailored to that activity. Scores on iADL sub-scale range between 0 and 59, with lower scores reflecting greater disease severity
Measured: Baseline over time until Week 72
Pharmacokinetic parameters of VHB937 in serum - Cmax
Cmax - The maximum concentration of VHB937 in serum
Measured: Baseline over time until Week 72
Pharmacokinetic parameters of VHB937 in serum - Tmax
Tmax - The time to reach the maximum concentration of VHB937 in serum
Measured: Baseline over time until Week 72
Pharmacokinetic parameters of VHB937 in serum - Ctrough
Ctrough - Minimum observed concentration of VHB937 in CSF
Measured: Baseline over time until Week 72
VHB937 immunogenicity in serum
Determination of anti-VHB937 antibodies in serum at selected timepoints
Measured: Baseline over time until Week 72
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2025
- Study start7 Aug 2025
- Primary completion14 Sep 2028 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer's DiseaseStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double-blind, Randomized
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07094516
- Sponsor's protocol ID
- CVHB937A12201
- Status last verified
- Oct 2026
- First submitted
- 23 Jul 2025
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com.