BridgeMD
A clinical trial to learn about the effects of VHB937 in people with Alzheimer's disease
EU CTIS ID: 2024-516966-12-00
What this study is testing
To evaluate the effect of VHB937 compared to placebo on cognition and function
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Male and female participants 50 to 85 years of age, with a maximum body weight of 180 kg at the time of signing the informed consent.
- Diagnosis of Mild Cognitive Impairment (MCI) due to AD or mild AD according to the NIA-AA criteria (Jack et al 2018) at Screening.
- Clinical Dementia Rating (CDR) Global score of 0.5 or 1.0 at Screening and Baseline.
- ADAS-Cog14 total score between CCI at Screening.
- Biomarker-based confirmation of Alzheimer disease (AD) at Screening based on cerebral spinal fluid (CSF) biomarkers or amyloid PET imaging. Historical confirmation of amyloid positivity by CSF or PET is accepted.
- Reliable study partner who can accompany the participant at study visits in which informant scales are administered.
You likely can't join if
- Dementia due to a condition other than AD including, but not limited to, frontal temporal dementia (FTD), Parkinson's disease, dementia with Lewy bodies, Huntington disease, vascular dementia.
- Transient ischemic attacks (TIA) or stroke occurring within 12 months prior to randomization.
- MRI evidence of more than CCI; any area of superficial siderosis; evidence of vasogenic edema; evidence of cerebral contusion, encephalomalacia, aneurysms, or infective lesions; evidence of multiple (≥ 2) lacunar infarcts irrespective of location or stroke involving a major vascular territory, severe small vessel, or white matter disease; space occupying lesions; or brain tumors (however, lesions diagnosed as meningiomas or arachnoid cysts and less than 1 cm at their greatest diameter need not be exclusionary).
- Uncontrolled thyroid disease or uncontrolled diabetes or clinically significant laboratory abnormalities for thyroid function or fasting glucose in central laboratory results at Screening, as assessed by Investigator. The Investigator should ensure that the diabetic participants remain adequately controlled during the study.
- Clinical evidence of liver disease or liver injury (other than hepatitis specified above) defined by any of the following results in central laboratory at Screening: · Total bilirubin > 1.5 x ULN, · Alkaline phosphatase (ALP) > 3 x ULN, · AST (SGOT) or ALT (SGPT) > 3 x ULN, and · Gamma-glutamyl-transferase (GGT) > 3 x ULN.
- History or current diagnosis of cardiovascular conditions indicating significant risk of safety for participants in the study such as, but not limited to: · Myocardial infarction or unstable angina (within 6 months of Screening), clinically significant cardiac arrhythmia (e.g., sustained ventricular tachycardia) requiring treatment and clinically significant second- or third-degree AV block without a pacemaker. · Familial long QT syndrome or known family history of Torsade de Pointe. · Resting QTcF ≥ 450 ms (male) or ≥ 460 ms (female) at Screening or inability to determine the QTcF interval
See the full eligibility criteria
Who can join
- Male and female participants 50 to 85 years of age, with a maximum body weight of 180 kg at the time of signing the informed consent.
- Diagnosis of Mild Cognitive Impairment (MCI) due to AD or mild AD according to the NIA-AA criteria (Jack et al 2018) at Screening.
- Clinical Dementia Rating (CDR) Global score of 0.5 or 1.0 at Screening and Baseline.
- ADAS-Cog14 total score between CCI at Screening.
- Biomarker-based confirmation of Alzheimer disease (AD) at Screening based on cerebral spinal fluid (CSF) biomarkers or amyloid PET imaging. Historical confirmation of amyloid positivity by CSF or PET is accepted.
- Reliable study partner who can accompany the participant at study visits in which informant scales are administered.
- Participants receiving an AChEI or memantine or both for AD must be on a stable dose for at least 12 weeks before Randomization. For participants who discontinued these medications before Screening, the stop date should be at least 12 weeks before Randomization. Treatment-naïve participants can be enrolled into the study.
What rules you out
- Dementia due to a condition other than AD including, but not limited to, frontal temporal dementia (FTD), Parkinson's disease, dementia with Lewy bodies, Huntington disease, vascular dementia.
- Transient ischemic attacks (TIA) or stroke occurring within 12 months prior to randomization.
- MRI evidence of more than CCI; any area of superficial siderosis; evidence of vasogenic edema; evidence of cerebral contusion, encephalomalacia, aneurysms, or infective lesions; evidence of multiple (≥ 2) lacunar infarcts irrespective of location or stroke involving a major vascular territory, severe small vessel, or white matter disease; space occupying lesions; or brain tumors (however, lesions diagnosed as meningiomas or arachnoid cysts and less than 1 cm at their greatest diameter need not be exclusionary).
- Uncontrolled thyroid disease or uncontrolled diabetes or clinically significant laboratory abnormalities for thyroid function or fasting glucose in central laboratory results at Screening, as assessed by Investigator. The Investigator should ensure that the diabetic participants remain adequately controlled during the study.
- Clinical evidence of liver disease or liver injury (other than hepatitis specified above) defined by any of the following results in central laboratory at Screening: · Total bilirubin > 1.5 x ULN, · Alkaline phosphatase (ALP) > 3 x ULN, · AST (SGOT) or ALT (SGPT) > 3 x ULN, and · Gamma-glutamyl-transferase (GGT) > 3 x ULN.
- History or current diagnosis of cardiovascular conditions indicating significant risk of safety for participants in the study such as, but not limited to: · Myocardial infarction or unstable angina (within 6 months of Screening), clinically significant cardiac arrhythmia (e.g., sustained ventricular tachycardia) requiring treatment and clinically significant second- or third-degree AV block without a pacemaker. · Familial long QT syndrome or known family history of Torsade de Pointe. · Resting QTcF ≥ 450 ms (male) or ≥ 460 ms (female) at Screening or inability to determine the QTcF interval
- Severe renal impairment (Glomerular Filtration Rate < 30 mL/min/1.73 m2) in central laboratory results at Screening.
The study team makes the final eligibility decision.
Where it's taking place
- Japan
- Canada
- Korea, Democratic People's Republic of
- United States
- United Kingdom
- China
- Australia
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, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Japan; Canada; Korea, Democratic People's Republic of; United States; United Kingdom; China and 1 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 EU CTIS; the study team decides eligibility.