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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
407
Jem Research Institute
Atlantis, Florida, United States
RECRUITINGVisionary Investigators Network
Aventura, Florida, United States
RECRUITINGChange 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 72
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)
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 72
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 72
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
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K2 Medical Research LLC
Maitland, Florida, United States
K2 Medical Research LLC
Maitland, Florida, United States
RECRUITINGCharter Research The Villages
The Villages, Florida, United States
RECRUITINGActivMed Practices and Research
Methuen, Massachusetts, United States
RECRUITINGAbington Neurological Associates Ltd
Willow Grove, Pennsylvania, United States
RECRUITINGNovartis Investigative Site
Toronto, Ontario, Canada
RECRUITINGNovartis Investigative Site
London, United Kingdom
RECRUITINGTime frame: Baseline over time until Week 72
Pharmacokinetic parameters of VHB937 in serum - Cmax
Cmax - The maximum concentration of VHB937 in serum
Time frame: Baseline over time until Week 72
Pharmacokinetic parameters of VHB937 in serum - Tmax
Tmax - The time to reach the maximum concentration of VHB937 in serum
Time frame: Baseline over time until Week 72
Pharmacokinetic parameters of VHB937 in serum - Ctrough
Ctrough - Minimum observed concentration of VHB937 in CSF
Time frame: Baseline over time until Week 72
VHB937 immunogenicity in serum
Determination of anti-VHB937 antibodies in serum at selected timepoints
Time frame: Baseline over time until Week 72