407 Participants Needed

VHB937 for Alzheimer's Disease

Recruiting at 7 trial locations
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Novartis Pharmaceuticals
Must be taking: AChEIs, Memantine
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called VHB937 for individuals with early Alzheimer's Disease (AD). Researchers aim to evaluate the effectiveness and safety of VHB937 compared to a placebo (a substance with no therapeutic effect). Participants will receive either a low dose, a high dose, or a placebo through IV infusions. Suitable candidates for this trial have mild memory problems associated with Alzheimer's, confirmed by specific brain tests. Participants should also have someone to accompany them to study visits. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to early-stage treatment development.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but if you are on Alzheimer's medications like AChEIs or memantine, you must be on a stable dose before starting the study.

Is there any evidence suggesting that VHB937 is likely to be safe for humans?

Research has shown that VHB937 is under investigation for its safety and effectiveness in individuals with early Alzheimer's disease. In earlier studies, VHB937 was tested on specific human cells and demonstrated promising results without serious side effects. However, since this study remains in Phase 2, the safety of VHB937 in humans continues to be evaluated. This phase aims to gather more information on how well participants tolerate the treatment and to identify any potential side effects. Participants will be closely monitored to ensure their safety throughout the study.12345

Why do researchers think this study treatment might be promising for Alzheimer's?

Unlike the standard treatments for Alzheimer's, which mostly focus on managing symptoms with drugs like donepezil or memantine, VHB937 offers a potentially groundbreaking approach. Researchers are excited about VHB937 because it targets the underlying disease mechanism rather than just alleviating symptoms. Administered through I.V. infusions in both low and high doses, VHB937 could potentially modify the course of Alzheimer's, offering hope for more effective treatment. This innovative approach has the potential to slow down disease progression, which is a significant leap forward compared to current therapies.

What evidence suggests that VHB937 might be an effective treatment for Alzheimer's?

Research has shown that VHB937 targets a protein called TREM2, which is linked to brain inflammation and cell damage in Alzheimer's disease. Studies suggest that stabilizing and activating TREM2 may help protect nerve cells. By influencing the actions of brain immune cells, VHB937 could potentially slow Alzheimer's progression. Early findings indicate this method might offer a new way to treat Alzheimer's by preventing further nerve cell damage. While researchers are still gathering human data, this strategy has shown promise in early studies of brain diseases. Participants in this trial will receive either a low dose or high dose of VHB937, or a placebo, to evaluate its effectiveness and safety.12346

Are You a Good Fit for This Trial?

This trial is for men and women aged 50-85 with early Alzheimer's Disease (AD), specifically those with Mild Cognitive Impairment or mild AD. Participants must have a study partner to accompany them, a specific score on the dementia rating scale, and confirmed AD through certain tests. Stable doses of current AD treatments are required before starting this study.

Inclusion Criteria

I meet the main requirements to join the study.
Key
My dementia is mild.
See 5 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive VHB937 or placebo via I.V. infusions in a double-blind manner

72 weeks
Regular visits for infusions and assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Extension

Participants may continue receiving VHB937 in an open-label extension

Long-term

What Are the Treatments Tested in This Trial?

Interventions

  • VHB937
Trial Overview The trial is testing VHB937 against a placebo in people with early Alzheimer's over 72 weeks, followed by an extension phase. It aims to evaluate how effective and safe VHB937 is compared to not receiving the active drug but being monitored under similar conditions.
How Is the Trial Designed?
3Treatment groups
Experimental Treatment
Placebo Group
Group I: VHB937 Low DoseExperimental Treatment1 Intervention
Group II: VHB937 High DoseExperimental Treatment1 Intervention
Group III: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Novartis Pharmaceuticals

Lead Sponsor

Trials
2,963
Recruited
4,275,000+
Founded
1996
Headquarters
Basel, Switzerland
Known For
Precision medicine
Top Products
Gleevec, Cosentyx, Entresto, Kisqali
Dr. Vas Narasimhan profile image

Dr. Vas Narasimhan

Novartis Pharmaceuticals

Chief Executive Officer since 2018

MD from Harvard Medical School

Dr. Shreeram Aradhye profile image

Dr. Shreeram Aradhye

Novartis Pharmaceuticals

Chief Medical Officer since 2021

MD

Citations

A Clinical Trial to Learn About the Effects of VHB937 in ...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 ...
NCT07094516 | A Clinical Trial to Learn About the Effects ...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 ...
VHB937, a TREM2 Stabilizing and Activating Antibody ...Objective:To examine the impact of the anti-human TREM2 agonistic mAb VHB937 in vitro and in vivo in models for neurodegenerative diseases.
Trials | Find a Study - University College London HospitalsBy modulating microglial function, VHB937 may help slow or prevent further nerve cell damage, offering a potential new treatment approach for AD ...
VHB937 for Alzheimer's DiseaseIt aims to evaluate how effective and safe VHB937 is compared to not receiving the active drug but being monitored under similar conditions. How ...
VHB937 Therapy for Early Alzheimer's DiseaseThe key aim is to determine if VHB937 is safe and can help improve memory and thinking skills, assist with daily activities, and influence changes in the brain ...
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