A Clinical Trial to Learn About the Effects of VHB937 in People With Early Alzheimer's Disease
- Conditions
- Alzheimer's Disease
- Interventions
- Other: Placebo
- Registration Number
- NCT07094516
- Lead Sponsor
- Novartis Pharmaceuticals
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 407
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description VHB937 Low Dose VHB937 I.V. infusions Placebo Placebo I.V. infusions VHB937 High Dose VHB937 I.V. infusions
- Primary Outcome Measures
Name Time Method Change from Baseline in the Clinical Dementia Rating scale - Sum of Boxes (CDR-SB) Baseline and Week 72 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
- Secondary Outcome Measures
Name Time Method Change from Baseline in instrumental activities of daily living (iADL) on the Alzheimers Disease Cooperative Study - Activities of Daily Living (ADCS-ADL) scale Baseline over time until Week 72 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
Pharmacokinetic parameters of VHB937 in serum - Cmax Baseline over time until Week 72 Cmax - The maximum concentration of VHB937 in serum
Pharmacokinetic parameters of VHB937 in serum - Ctrough Baseline over time until Week 72 Ctrough - Minimum observed concentration of VHB937 in CSF
VHB937 immunogenicity in serum Baseline over time until Week 72 Determination of anti-VHB937 antibodies in serum at selected timepoints
Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs) From First treatment to end of study (up to 63 months approximately) 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.
Change from Baseline in Alzheimer's Disease Assessment Scale-Cognitive (ADAS-Cog14) Baseline over time until Week 72 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
Change from Baseline in Clinical Dementia Rating scale - Sum of Boxes (CDR-SB) Baseline over time until Week 72 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.
Pharmacokinetic parameters of VHB937 in serum - Tmax Baseline over time until Week 72 Tmax - The time to reach the maximum concentration of VHB937 in serum