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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
VHB937
Biological/VaccineVHB937 solution for infusion
VHB937
Biological/VaccineVHB937 solution for infusion
Placebo
Other interventionSolution for infusion
Treatment groups
407 Participants
are divided into 3 treatment groupsGroup A: VHB937 Low DoseExperimental treatment 1 intervention
Group B: VHB937 High DoseExperimental treatment 1 intervention
Group C: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change from Baseline in the Clinical Dementia Rating scale - Sum of Boxes (CDR-SB)
The CDR is a measure of cognition and function, widely used in clinical research in AD. The scale assesses six domains: Memory, Orientation, Judgment \& Problem Solving, Community Affairs, Home \& Hobbies, and Personal Care. Based on in-depth semi-structured interview, each domain is assigned a score, which is summed to obtain the Sum of Boxes (SB) score, ranging from 0 to 18 with higher scores indicating worse condition
Time frame
Baseline and Week 72Secondary outcomes
1
Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Incidence and severity of AEs and SAEs by treatment group, including Safety findings, Laboratory tests, Vital signs and, ECG findings qualifying and reported as AEs.
Time frame
From First treatment to end of study (up to 63 months approximately)2
Change from Baseline in Clinical Dementia Rating scale - Sum of Boxes (CDR-SB)
The CDR is a measure of cognition and function, widely used in clinical research in AD. The scale assesses six domains: Memory, Orientation, Judgment \& Problem Solving, Community Affairs, Home \& Hobbies, and Personal Care.
Time frame
Baseline over time until Week 723
Change from Baseline in Alzheimer's Disease Assessment Scale-Cognitive (ADAS-Cog14)
The ADAS-Cog is is a 14-item clinical assessment tool to measure cognition. The ADAS-Cog14 score ranges between 0 and 90, with higher scores indicating worse cognitive performance
Time frame
Baseline over time until Week 724
Change from Baseline in instrumental activities of daily living (iADL) on the Alzheimers Disease Cooperative Study - Activities of Daily Living (ADCS-ADL) scale
The ADCS-ADL is a 23-item study partner scale designed to assess the ability of patients with AD to carry out basic activities of daily living (bADLs) and instrumental activities of daily living (iADLs). For each item, the study partner is asked whether the participant attempted the activity in the 4 preceding weeks. Where 'yes' is the answer, the study partner is asked to rate the patient's level of performance according to a set of descriptors tailored to that activity. Scores on iADL sub-scale range between 0 and 59, with lower scores reflecting greater disease severity
Time frame
Baseline over time until Week 72Sponsors and contacts
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Source ClinicalTrials.gov