RecruitingPhase 2

A Clinical Trial to Learn About the Effects of VHB937 in People With Early Alzheimer's Disease

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

Lead sponsor

Novartis Pharmaceuticals

Asset

VHB937

Listed sites

Recruiting sites

Enrollment

407

estimated

Study population

Alzheimer’s disease

Key I/E criteria

•Alzheimer's disease•Amyloid biomarker required (PET/CSF)•CDR global 0.5•Study partner/caregiver required•AD symptomatic therapy: stable

Primary endpoint

•Clinical Dementia Rating-Sum of Boxes (CDR-SB)

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Org study IDCVHB937A12201

NCT IDNCT07094516

Timeline

Milestones

Study first posted2025-07-30actual

Study start2025-08-07actual

Last update posted2026-06-26actual

Primary completion2028-09-14estimated

Study completion2030-12-31estimated

Assets

Drug assets

VHB937

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age50 Years

Maximum age85 Years

SexAll

Healthy volunteersNot accepted

Inclusion 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

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

Endpoints (9)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Safety / tolerability / PK

Global cognition

Function / daily living

Fluid / digital biomarkers

Global cognition

3 endpoints

Primary/protocol endpoint

Change from Baseline in the Clinical Dementia Rating scale - Sum of Boxes (CDR-SB)

Time frame:Baseline and Week 72

Clinical Dementia Rating-Sum of Boxes (CDR-SB)

change from baseline, improvement

Secondary/protocol endpoint

Change from Baseline in Clinical Dementia Rating scale - Sum of Boxes (CDR-SB)

Time frame:Baseline over time until Week 72

Clinical Dementia Rating-Sum of Boxes (CDR-SB)

change from baseline, improvement

Secondary/protocol endpoint

Change from Baseline in Alzheimer's Disease Assessment Scale-Cognitive (ADAS-Cog14)

Time frame:Baseline over time until Week 72

ADAS-Cog

change from baseline, improvement

Function / daily living

1 endpoint

Secondary/protocol endpoint

Change from Baseline in instrumental activities of daily living (iADL) on the Alzheimers Disease Cooperative Study - Activities of Daily Living (ADCS-ADL) scale

Time frame:Baseline over time until Week 72

ADCS-Activities of Daily Living (ADCS-ADL)

change from baseline, improvement

Fluid / digital biomarkers

1 endpoint

Secondary/protocol endpoint

Pharmacokinetic parameters of VHB937 in serum - Ctrough

Time frame:Baseline over time until Week 72

concentration, descriptive

Safety / tolerability / PK

4 endpoints

Secondary/protocol endpoint

Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)

Time frame:From First treatment to end of study (up to 63 months approximately)

event count, event

Secondary/protocol endpoint

Pharmacokinetic parameters of VHB937 in serum - Cmax

Time frame:Baseline over time until Week 72

concentration, descriptive

Secondary/protocol endpoint

Pharmacokinetic parameters of VHB937 in serum - Tmax

Time frame:Baseline over time until Week 72

time to event, event

Secondary/protocol endpoint

VHB937 immunogenicity in serum

Time frame:Baseline over time until Week 72

descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.