A Clinical Trial to Learn About the Effects of VHB937 in People With Early Alzheimer's Disease
ConditionAlzheimer's Disease
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age50-85
SponsorNovartis Pharmaceuticals
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- VHB937
- VHB937
- Placebo
Treatment groups
407 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov