A Phase 2 interventional study of VHB937 and VHB937 in Alzheimer's Disease, sponsored by Novartis Pharmaceuticals. Recruiting at 74 sites in 15 countries. Open to participants aged 50 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-06-26.
Sponsored by Novartis Pharmaceuticals · Phase 2, Interventional, and Treatment
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.
3,675 studies on the registry are indexed under Alzheimer Disease; 869 are open to participants now.
This study's planned enrollment of 407 is above the median of 70 across 2,805 interventional studies indexed under Alzheimer Disease.
Browse Alzheimer Disease studies →Novartis Pharmaceuticals is the lead sponsor of 2,673 studies on the registry; 228 are open to participants now.
Of its 576 completed or terminated interventional studies of FDA-regulated products, 431 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria
Key Exclusion Criteria
Other protocol-defined inclusion/exclusion criteria may apply
I.V. infusions
Biological: VHB937
I.V. infusions
Biological: VHB937
I.V. infusions
Other: Placebo
VHB937 solution for infusion
VHB937 solution for infusion
Solution for infusion
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
Time frame: Baseline and Week 72
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.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: Baseline over time until Week 72
Pharmacokinetic parameters of VHB937 in serum - Cmax
Cmax - The maximum concentration of VHB937 in serum
Time frame: 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
Time frame: Baseline over time until Week 72
Pharmacokinetic parameters of VHB937 in serum - Ctrough
Ctrough - Minimum observed concentration of VHB937 in CSF
Time frame: Baseline over time until Week 72
VHB937 immunogenicity in serum
Determination of anti-VHB937 antibodies in serum at selected timepoints
Time frame: Baseline over time until Week 72
Plan to share: 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.
No publications or documents are linked to this record.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Novartis Pharmaceuticals