A Clinical Trial to Learn About the Effects of VHB937 in People With Early Alzheimer's Disease
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
1 other identifier
interventional
407
14 countries
65
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Aug 2025
Longer than P75 for phase_2
65 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 23, 2025
CompletedFirst Posted
Study publicly available on registry
July 30, 2025
CompletedStudy Start
First participant enrolled
August 7, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 14, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2030
May 14, 2026
May 1, 2026
3.1 years
July 23, 2025
May 13, 2026
Conditions
Keywords
Outcome Measures
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
Baseline and Week 72
Secondary Outcomes (8)
Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)
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)
Baseline over time until Week 72
Change from Baseline in Alzheimer's Disease Assessment Scale-Cognitive (ADAS-Cog14)
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
Baseline over time until Week 72
Pharmacokinetic parameters of VHB937 in serum - Cmax
Baseline over time until Week 72
- +3 more secondary outcomes
Study Arms (3)
VHB937 Low Dose
EXPERIMENTALI.V. infusions
VHB937 High Dose
EXPERIMENTALI.V. infusions
Placebo
PLACEBO COMPARATORI.V. infusions
Interventions
Eligibility Criteria
You may qualify if:
- 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
- Reliable study partner who can accompany the participant at study visits
- If on symptomatic AD treatment (AChEIs/memantine), on a stable dose prior to starting study treatment
You may not qualify if:
- 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
- Current major depressive episode that is not adequately controlled, history of schizophrenia, other chronic psychosis
- Significant neurological disease other than dementia (e.g. serious brain infection, traumatic brain injury, multiple concussions, epilepsy or recurrent seizures
- Presence of suicidal ideation within 6 months or suicidal behavior within 2 years before Screening
- Presence of cancer, HIV, Hep B, Hep C, uncontrolled thyroid disease, uncontrolled diabetes
- Taking any prohibited medications
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (65)
Banner Alzheimers Institute
Phoenix, Arizona, 85006, United States
Irvine Center for Clinical Research
Irvine, California, 92618, United States
University of California San Diego
La Jolla, California, 92037, United States
University of California at Los Angeles
Los Angeles, California, 90095, United States
Jem Research Institute
Atlantis, Florida, 33462-6608, United States
Visionary Investigators Network
Aventura, Florida, 33180, United States
K2 Medical Research LLC
Maitland, Florida, 32751, United States
K2 Medical Research LLC
Maitland, Florida, 32751, United States
Renstar Medical Research
Ocala, Florida, 34471, United States
Charter Research The Villages
The Villages, Florida, 32162, United States
Alzheimers Research Treatment Ctr
Wellington, Florida, 33414, United States
Alzheimers Research Treatment Ctr
Wellington, Florida, 33414, United States
Conquest Research
Winter Park, Florida, 32789, United States
Hawaii Pacific Neuroscience LLC
Honolulu, Hawaii, 96817, United States
University of Kansas Hospital
Fairway, Kansas, 66205, United States
ActivMed Practices and Research
Methuen, Massachusetts, 01844, United States
Citizens Memorial Hospital Neurology CLinic
Bolivar, Missouri, 65613, United States
Lou Ruvo Center for Brain Health
Las Vegas, Nevada, 89106, United States
UNC Hosp Invest Drug Serv Pharm
Chapel Hill, North Carolina, 27514, United States
The Ohio State University
Columbus, Ohio, 43210, United States
Neural Net Research
Portland, Oregon, 97225, United States
Abington Neurological Associates Ltd
Willow Grove, Pennsylvania, 19090, United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229-3900, United States
University of Washington Medical Center
Seattle, Washington, 98195, United States
Novartis Investigative Site
Camperdown, New South Wales, 2050, Australia
Novartis Investigative Site
Kogarah, New South Wales, 2217, Australia
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Box Hill, Victoria, 3128, Australia
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London, Ontario, N6G 3H7, Canada
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North York, Ontario, M6A 2C8, Canada
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Toronto, Ontario, M3B 2S7, Canada
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Toronto, Ontario, M5T 2S8, Canada
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Brno, 602 00, Czechia
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Prague, 160 00, Czechia
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Toulouse, Haute Garonne, 31059, France
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Paris, 75013, France
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Berlin, 12200, Germany
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Berlin, 13353, Germany
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München, 80377, Germany
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Cefalù, PA, 90015, Italy
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Perugia, PG, 06129, Italy
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Itabashi Ku, Tokyo, 1730015, Japan
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Kodaira, Tokyo, 187-8551, Japan
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Shinjuku Ku, Tokyo, 160-0023, Japan
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Amsterdam, 1081 GN, Netherlands
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Bialystok, 15-756, Poland
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Oświęcim, 32-600, Poland
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Wroclaw, 53659, Poland
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Seoul, Korea, 05505, South Korea
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Incheon, 21565, South Korea
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Incheon, 22332, South Korea
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Seoul, 03080, South Korea
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Seoul, 04763, South Korea
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Seoul, 05030, South Korea
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Pamplona, Navarre, 31008, Spain
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Valencia, Valencia, 46017, Spain
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Valencia, 46026, Spain
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Mölndal, 431 80, Sweden
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Stockholm, 141 86, Sweden
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Edinburgh, Lothian, EH12 5PJ, United Kingdom
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Aberdeen, AB25 2ZH, United Kingdom
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London, SE5 8AF, United Kingdom
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London, W1G 9JF, United Kingdom
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London, WC1N 3BG, United Kingdom
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Newcastle upon Tyne, NE4 6BE, United Kingdom
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Southampton, SO16 6YD, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Blinded placebo for infusion
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 23, 2025
First Posted
July 30, 2025
Study Start
August 7, 2025
Primary Completion (Estimated)
September 14, 2028
Study Completion (Estimated)
December 31, 2030
Last Updated
May 14, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will share
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com.