NCT07094516 A Clinical Trial to Learn About the Effects of VHB937 in People With Early Alzheimer's Disease
| NCT ID | NCT07094516 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Novartis Pharmaceuticals |
| Condition | Alzheimer's Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 407 participants |
| Start Date | 2025-08-07 |
| Primary Completion | 2028-09-14 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 407 participants in total. It began in 2025-08-07 with a primary completion date of 2028-09-14.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07094516 clinical trial?
This trial is open to participants of all sexes, aged 50 Years or older, up to 85 Years, studying Alzheimer's Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07094516 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07094516 currently recruiting?
Yes, NCT07094516 is actively recruiting participants. Contact the research team at novartis.email@novartis.com for enrollment information.
Where is the NCT07094516 trial being conducted?
This trial is being conducted at Phoenix, United States, Irvine, United States, La Jolla, United States, Los Angeles, United States and 11 additional locations.
Who is sponsoring the NCT07094516 clinical trial?
NCT07094516 is sponsored by Novartis Pharmaceuticals. The trial plans to enroll 407 participants.
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