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New treatment option for Alzheimer's Disease
Official title A Clinical Trial to Learn About the Effects of VHB937 in People With Early Alzheimer's Disease
ClinicalTrials.gov ID: NCT07094516
What this study is testing
What is VHB937?
VHB937 is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for alzheimer's disease.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 50 to 85
You may be able to join if
- Key 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
You likely can't join if
- Dementia due to a condition other than AD, including but not limited to, frontal temporal dementia, Parkinson's disease, dementia with Lewy bodies...
- 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...
See the full eligibility criteria
- Key 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Phoenix, Arizona, United States
- Irvine, California, United States
- La Jolla, California, United States
- Los Angeles, California, United States
- Atlantis, Florida, United States
- Aventura, Florida, United States
- Maitland, Florida, United States
- Ocala, Florida, United States
- The Villages, Florida, United States
- Wellington, Florida, United States
- Winter Park, Florida, United States
- Honolulu, Hawaii, United States
- Fairway, Kansas, United States
- Methuen, Massachusetts, United States
- Bolivar, Missouri, United States
- Las Vegas, Nevada, United States
- Chapel Hill, North Carolina, United States
- Columbus, Ohio, United States
- Portland, Oregon, United States
- Willow Grove, Pennsylvania, United States
+ 47 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 50 years to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Phoenix, Arizona, United States; Irvine, California, United States; La Jolla, California, United States; Los Angeles, California, United States; Atlantis, Florida, United States; Aventura, Florida, United States and 61 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.