A Clinical Trial to Learn About the Effects of VHB937 in People With Early Alzheimer's Disease
Recruiting
Phase 2Interventional Study
Alzheimer's Disease
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
50 – 85
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
407 (estimated)
Sponsor
Novartis Pharmaceuticals · Industry
Who this trial is looking for
This trial is looking for people aged 50 to 85 with early Alzheimer's disease. Participants will take VHB937 for up to 72 weeks and will have regular visits with a study partner.
Are You a Good Fit for This Trial?
You may be able to join if
I am between 50 to 85 years old.
I have been diagnosed with mild cognitive impairment or mild Alzheimer's disease.
My clinical dementia rating score is 0.5 or 1.0.
I have had tests confirming Alzheimer's disease.
I have a reliable study partner who can come with me to visits.
I am on a stable dose of any current Alzheimer's treatment.
You may not be able to join if
I have dementia due to conditions other than Alzheimer's.
I have had significant heart problems or ECG issues.
I have had a stroke or transient ischemic attack in the past year.
I have liver or kidney disease.
I am currently experiencing major depression that is not controlled.
I have significant neurological diseases other than dementia.
I have thought about suicide in the last 6 months.
I have cancer, HIV, or hepatitis B or C.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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.
Trial Locations
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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
* Re…
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
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