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VHB937 treatment for 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

Phase 2 Interventional Novartis · NCT07094516

This trial will test whether VHB937 can slow memory and thinking decline in people aged 50–85 who have early Alzheimer's disease confirmed by biomarkers.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment407 (estimated)
Ages50 Years to 85 Years
SexAll
SponsorNovartis Industry-sponsored
Locations52 sites (Phoenix, Arizona and 51 other locations)
Trial IDNCT07094516 on ClinicalTrials.gov

What this trial studies

This is a multicenter, randomized, double-blind, placebo-controlled Phase II study with a 72-week double-blind treatment period followed by an extension. Participants have biomarker-confirmed mild cognitive impairment due to AD or mild AD and must have a reliable study partner for visits. The study will track safety, cognitive tests, daily function, brain imaging or fluid biomarkers, and how the drug is processed by the body. Standard symptomatic AD medications are allowed if the dose is stable before starting treatment.

Who should consider this trial

Good fit: Ideal candidates are adults 50–85 years old with biomarker-confirmed MCI due to AD or mild AD (CDR global 0.5–1.0) who have a reliable study partner and are on stable doses of any symptomatic AD medications.

Not a fit: People with dementia from non‑Alzheimer causes, recent stroke or TIA, significant cardiac, liver, or kidney disease, active major depression, or those outside the 50–85 age range are unlikely to benefit or may be excluded for safety reasons.

Why it matters

Potential benefit: If successful, VHB937 could slow cognitive decline and help people with early Alzheimer's maintain daily functioning longer.

How similar studies have performed: Other anti-amyloid monoclonal antibodies have shown some ability to slow decline in early AD (for example lecanemab) but with important safety considerations such as ARIA, so this approach has partial precedent.

Eligibility criteria

Show full inclusion / exclusion 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

Where this trial is running

Phoenix, Arizona and 51 other locations

+2 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Alzheimer's DiseaseAlzheimer's diseaseADDementiaMonoclonal Antibody
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.