A clinical trial to learn about the effects of VHB937 in people with Alzheimer's disease

Trial details

Who runs it

Novartis Pharma AG

Trial code

EU 2024-516966-12-00

Record updated

2026. október 12.

Original description

To evaluate the effect of VHB937 compared to placebo on cognition and functionRead full original descriptionShow less

A randomized, placebo-controlled, parallel group, 72-week study to evaluate the efficacy and safety of VHB937 in participants with early Alzheimer’s Disease followed by an Extension

To evaluate the effect of VHB937 compared to placebo on cognition and function

Inclusion: 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.

Exclusion: Transient ischemic attacks (TIA) or stroke occurring within 12 months prior to randomization; 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; 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.

EU CTIS 2024-516966-12-00