Dementia Support Line
Study of VHB937 in people with early Alzheimer's disease
Status
Contact
Use the information below to reference this clinical trial when speaking with your healthcare professional or research team.
Note: the information presented on the Clinical Trial Finder is for information only. To join a clinical trial you must meet the eligibility criteria set by the study and the research team will discuss this with you.
This trial is open to recruitment at the following location. Contact at their email address.
Contact the Clinical Trials team
- National Hospital for Neurology and Neurosurgery (UCLH), London: [email protected]
Trial description
What is the aim of the study?
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 the safety of VHB937, as well as its effects on memory and other thinking abilities, on daily activities, and on changes in the brain. The study will also observe and measure how VHB937 is processed by the body and how the body responds to it.
The aim of this study is to compare the study medicine VHB937 with a placebo (a treatment with no active medicine) to see:
- How VHB937 affects memory, other thinking abilities, daily activities and changes in the brain in people with Early Alzheimer’s Disease
- How safe VHB937 is in people who have early signs of Alzheimer’s disease.
How the study is carried out
This study is a double-blind placebo-controlled trial. This means participants will be selected at random to receive one of the following options:
- An intravenous infusion of VHB937 (low dose)
- An intravenous infusion of VHB937 (high dose)
- An intravenous infusion of Placebo (a 'dummy' treatment, which is an inactive substance with no active therapeutic effect that looks the same as the study drug).
Neither the participant, their study doctor, nor the study team will know who is getting the investigational treatment or placebo. This helps make the results fair.
After the double-blind part of the study participants will be offered the chance to join an extension phase, where they can continue receiving VHB937 in an open label format (meaning everyone receives the real drug, with no placebo). Your study doctor would discuss this with you.
Find more information about why studies use blinding, randomisation and placebo controls.
How is the drug given?
VHB937 or placebo is given by intravenous (IV) infusion, which is a drip into a vein in the arm.
Is the drug already approved for other illnesses?
No, VHB937 is not currently used or sold for any medical condition.
How long does treatment last?
The double-blind part of the study is 72 weeks long (about 1.5 years), followed by an optional open label extension.
What will participants need to do?
During the study, participants will:
- Take tests which check:
- Memory
- Thinking skills (cognition)
- Function
- Daily activities
- Behaviour
- Have positron emission tomography (PET) scans, which take pictures of the brain to check for changes linked to Alzheimer’s disease.
- Have lab tests and checkups which will include:
- blood tests and other lab tests
- neurological exams which help doctors look for any new side effects, such as symptoms or health changes that might happen after receiving the study drug.
Eligibility criteria
Who can participate
- People who have been diagnosed with mild cognitive impairment (MCI) due to Alzheimer’s disease, or, who have been diagnosed with mild Alzheimer’s disease
- People who have confirmation of Alzheimer’s disease based on cerebral spinal fluid (CSF) biomarkers or amyloid PET imaging
- To take part in this study you must have a study partner (a close friend or family member who has regular contact with you and can provide information at study visits).
- If you are taking approved symptomatic medication for Alzheimer’s disease (i.e. donepezil, rivastigmine, galantamine or memantine), your dose must have been stable for at least 12 weeks prior to starting study treatment.
Who cannot participate
- People who have dementia due to a condition other than Alzheimer’s disease, 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
- People who have a significant neurological disease other than dementia (e.g. serious brain infection, traumatic brain injury, multiple concussions, epilepsy or recurrent seizures)
- People who have a disease that may interfere with the safety or study assessments (e.g., cancer, Human immunodeficiency virus (HIV), hepatitis B, hepatitis C, uncontrolled thyroid disease, uncontrolled diabetes. major depressive episode that is not adequately controlled, history of schizophrenia, other chronic psychosis)
- People who have evidence of cardiac (heart), liver or renal (kidney) disease and / or injury
- People who have a history of transient ischemic attacks (TIA) or stroke occurring within past 12 months
- People who have experienced suicidal ideation within 6 months or suicidal behaviour within 2 years before screening.
- People taking any prohibited medications
- Other specific medical criteria will apply, a study doctor will discuss these with you and assess if you are able to participate in the study.
Clinical trial team
Age range
Recruitment start
Recruitment end
Disease type
Mechanism of action
Trial locations
Length of participation
Eligibility criteria
Who can participate
- People who have been diagnosed with mild cognitive impairment (MCI) due to Alzheimer’s disease, or, who have been diagnosed with mild Alzheimer’s disease
- People who have confirmation of Alzheimer’s disease based on cerebral spinal fluid (CSF) biomarkers or amyloid PET imaging
- To take part in this study you must have a study partner (a close friend or family member who has regular contact with you and can provide information at study visits).
- If you are taking approved symptomatic medication for Alzheimer’s disease (i.e. donepezil, rivastigmine, galantamine or memantine), your dose must have been stable for at least 12 weeks prior to starting study treatment.
Who cannot participate
- People who have dementia due to a condition other than Alzheimer’s disease, 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
- People who have a significant neurological disease other than dementia (e.g. serious brain infection, traumatic brain injury, multiple concussions, epilepsy or recurrent seizures)
- People who have a disease that may interfere with the safety or study assessments (e.g., cancer, Human immunodeficiency virus (HIV), hepatitis B, hepatitis C, uncontrolled thyroid disease, uncontrolled diabetes. major depressive episode that is not adequately controlled, history of schizophrenia, other chronic psychosis)
- People who have evidence of cardiac (heart), liver or renal (kidney) disease and / or injury
- People who have a history of transient ischemic attacks (TIA) or stroke occurring within past 12 months
- People who have experienced suicidal ideation within 6 months or suicidal behaviour within 2 years before screening.
- People taking any prohibited medications
- Other specific medical criteria will apply, a study doctor will discuss these with you and assess if you are able to participate in the study.