Actively Recruiting
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
Led by Novartis Pharmaceuticals · Updated on 2026-05-14
407
Participants Needed
65
Research Sites
119 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effects of a drug called VHB937 in people with early Alzheimer's disease. This is a Phase II, multicenter, randomized, double-blind, placebo-controlled study that lasts 72 weeks, followed by an extension phase. The study aims to see if VHB937 can safely improve memory, thinking abilities, daily activities, and brain changes in individuals diagnosed with mild cognitive impairment or mild Alzheimer's disease confirmed by specific biomarkers. Participants will receive intravenous infusions of either a low dose or high dose of VHB937, or a placebo. The study groups are assigned randomly and neither the participant nor the researchers know who receives which treatment during the 72-week double-blind period. After this, there is an extension phase to continue monitoring participants. During the study, participants will have regular assessments including memory and cognitive tests, evaluations of daily living activities, brain imaging, and blood tests to track how the body processes the drug and its immune response. Safety will be monitored by recording any adverse events throughout the study, which can last up to about 63 months. The main outcome measured is the change in the Clinical Dementia Rating scale over 72 weeks.
CONDITIONS
Brief Title
A Clinical Trial to Learn About the Effects of VHB937 in People With Early Alzheimer's Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female participants aged 50 to 85 years
- Diagnosis of Mild Cognitive Impairment due to Alzheimer's disease or mild Alzheimer's disease
- Clinical Dementia Rating Global score of 0.5 or 1.0
- Confirmation of Alzheimer's disease by cerebrospinal fluid biomarkers or amyloid PET imaging
- Availability of a reliable study partner to accompany participant to visits
- If using symptomatic Alzheimer's treatment (AChEIs or memantine), must be on stable dose before study treatment start
You will not qualify if you...
- Dementia caused by conditions other than Alzheimer's disease, such as frontal temporal dementia, Parkinson's disease, dementia with Lewy bodies, Huntington disease, or vascular dementia
- History or current diagnosis of cardiac conditions or ECG abnormalities posing significant risk
- Transient ischemic attacks or stroke within 12 months prior to study
- Clinical signs of liver or kidney disease or injury
- Current uncontrolled major depressive episode, history of schizophrenia or other chronic psychosis
- Significant neurological diseases other than dementia, including serious brain infection, traumatic brain injury, multiple concussions, epilepsy, or recurrent seizures
- Suicidal ideation within 6 months or suicidal behavior within 2 years before screening
- Presence of cancer, HIV, hepatitis B or C, uncontrolled thyroid disease, or uncontrolled diabetes
- Use of any prohibited medications
- Other protocol-defined inclusion or exclusion criteria may apply
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 72 weeks
Participants receive VHB937 or placebo through intravenous infusions to evaluate the safety and effects on memory, daily activities, and brain changes.
Regular visits for infusions and assessments during the 72-week treatment period
Trial Site Locations
Total: 65 locations
1
Banner Alzheimers Institute
Phoenix, Arizona, United States, 85006
Actively Recruiting
2
Irvine Center for Clinical Research
Irvine, California, United States, 92618
Actively Recruiting
3
University of California San Diego
La Jolla, California, United States, 92037
Actively Recruiting
4
University of California at Los Angeles
Los Angeles, California, United States, 90095
Actively Recruiting
5
Jem Research Institute
Atlantis, Florida, United States, 33462-6608
Actively Recruiting
6
Visionary Investigators Network
Aventura, Florida, United States, 33180
Actively Recruiting
7
K2 Medical Research LLC
Maitland, Florida, United States, 32751
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8
K2 Medical Research LLC
Maitland, Florida, United States, 32751
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9
Renstar Medical Research
Ocala, Florida, United States, 34471
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10
Charter Research The Villages
The Villages, Florida, United States, 32162
Actively Recruiting
11
Alzheimers Research Treatment Ctr
Wellington, Florida, United States, 33414
Actively Recruiting
12
Alzheimers Research Treatment Ctr
Wellington, Florida, United States, 33414
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13
Conquest Research
Winter Park, Florida, United States, 32789
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14
Hawaii Pacific Neuroscience LLC
Honolulu, Hawaii, United States, 96817
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15
University of Kansas Hospital
Fairway, Kansas, United States, 66205
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16
ActivMed Practices and Research
Methuen, Massachusetts, United States, 01844
Actively Recruiting
17
Citizens Memorial Hospital Neurology CLinic
Bolivar, Missouri, United States, 65613
Actively Recruiting
18
Lou Ruvo Center for Brain Health
Las Vegas, Nevada, United States, 89106
Actively Recruiting
19
UNC Hosp Invest Drug Serv Pharm
Chapel Hill, North Carolina, United States, 27514
Actively Recruiting
20
The Ohio State University
Columbus, Ohio, United States, 43210
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21
Neural Net Research
Portland, Oregon, United States, 97225
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22
Abington Neurological Associates Ltd
Willow Grove, Pennsylvania, United States, 19090
Actively Recruiting
23
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States, 78229-3900
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24
University of Washington Medical Center
Seattle, Washington, United States, 98195
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25
Novartis Investigative Site
Camperdown, New South Wales, Australia, 2050
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26
Novartis Investigative Site
Kogarah, New South Wales, Australia, 2217
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27
Novartis Investigative Site
Box Hill, Victoria, Australia, 3128
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28
Novartis Investigative Site
London, Ontario, Canada, N6G 3H7
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29
Novartis Investigative Site
North York, Ontario, Canada, M6A 2C8
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30
Novartis Investigative Site
Toronto, Ontario, Canada, M3B 2S7
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31
Novartis Investigative Site
Toronto, Ontario, Canada, M5T 2S8
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32
Novartis Investigative Site
Brno, Czechia, 602 00
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33
Novartis Investigative Site
Prague, Czechia, 160 00
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34
Novartis Investigative Site
Toulouse, Haute Garonne, France, 31059
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35
Novartis Investigative Site
Paris, France, 75013
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36
Novartis Investigative Site
Berlin, Germany, 12200
Actively Recruiting
37
Novartis Investigative Site
Berlin, Germany, 13353
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38
Novartis Investigative Site
München, Germany, 80377
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39
Novartis Investigative Site
Cefalù, PA, Italy, 90015
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40
Novartis Investigative Site
Perugia, PG, Italy, 06129
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41
Novartis Investigative Site
Itabashi Ku, Tokyo, Japan, 1730015
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42
Novartis Investigative Site
Kodaira, Tokyo, Japan, 187-8551
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43
Novartis Investigative Site
Shinjuku Ku, Tokyo, Japan, 160-0023
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44
Novartis Investigative Site
Amsterdam, Netherlands, 1081 GN
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45
Novartis Investigative Site
Bialystok, Poland, 15-756
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46
Novartis Investigative Site
Oświęcim, Poland, 32-600
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47
Novartis Investigative Site
Wroclaw, Poland, 53659
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48
Novartis Investigative Site
Seoul, Korea, South Korea, 05505
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49
Novartis Investigative Site
Incheon, South Korea, 21565
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50
Novartis Investigative Site
Incheon, South Korea, 22332
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51
Novartis Investigative Site
Seoul, South Korea, 03080
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52
Novartis Investigative Site
Seoul, South Korea, 04763
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53
Novartis Investigative Site
Seoul, South Korea, 05030
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54
Novartis Investigative Site
Pamplona, Navarre, Spain, 31008
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55
Novartis Investigative Site
Valencia, Valencia, Spain, 46017
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56
Novartis Investigative Site
Valencia, Spain, 46026
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57
Novartis Investigative Site
Mölndal, Sweden, 431 80
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58
Novartis Investigative Site
Stockholm, Sweden, 141 86
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59
Novartis Investigative Site
Edinburgh, Lothian, United Kingdom, EH12 5PJ
Actively Recruiting
60
Novartis Investigative Site
Aberdeen, United Kingdom, AB25 2ZH
Actively Recruiting
61
Novartis Investigative Site
London, United Kingdom, SE5 8AF
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62
Novartis Investigative Site
London, United Kingdom, W1G 9JF
Actively Recruiting
63
Novartis Investigative Site
London, United Kingdom, WC1N 3BG
Actively Recruiting
64
Novartis Investigative Site
Newcastle upon Tyne, United Kingdom, NE4 6BE
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65
Novartis Investigative Site
Southampton, United Kingdom, SO16 6YD
Actively Recruiting
Research Team
N
Novartis Pharmaceuticals
N
Novartis Pharmaceuticals
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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