A Clinical Trial to Learn About the Effects of VHB937 in People With Early Alzheimer's Disease

Recruiting · NCT07094516 · Interventional (participants receive a specific treatment) · Lead sponsor: Novartis Pharmaceuticals

View the official record on ClinicalTrials.gov →

Alzheimer's Disease

Interventions studied

PlaceboVHB937

What this trial is about

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.

Who can take part

Age range

50 Years to 85 Years

Sex

All (male and female)

Healthy volunteers

No - a diagnosis or condition is required

Phase

Phase 2

Study type

Interventional (participants receive a specific treatment)

Inclusion criteria

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
Key

Exclusion criteria

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
ther protocol-defined inclusion/exclusion criteria may apply

Where it is running

60 locations listed across 14 US states.

Banner Alzheimers Institute - Phoenix, Arizona, United States
Irvine Center for Clinical Research - Irvine, California, United States
University of California San Diego - La Jolla, California, United States
University of California at Los Angeles - Los Angeles, California, United States
Jem Research Institute - Atlantis, Florida, United States
Visionary Investigators Network - Aventura, Florida, United States
K2 Medical Research LLC - Maitland, Florida, United States
K2 Medical Research LLC - Maitland, Florida, United States
Renstar Medical Research - Ocala, Florida, United States
Charter Research The Villages - The Villages, Florida, United States
Alzheimers Research Treatment Ctr - Wellington, Florida, United States
Alzheimers Research Treatment Ctr - Wellington, Florida, United States
Conquest Research - Winter Park, Florida, United States
Hawaii Pacific Neuroscience LLC - Honolulu, Hawaii, United States
University of Kansas Hospital - Fairway, Kansas, United States
ActivMed Practices and Research - Methuen, Massachusetts, United States
Citizens Memorial Hospital Neurology CLinic - Bolivar, Missouri, United States
Lou Ruvo Center for Brain Health - Las Vegas, Nevada, United States
UNC Hosp Invest Drug Serv Pharm - Chapel Hill, North Carolina, United States
The Ohio State University - Columbus, Ohio, United States
Neural Net Research - Portland, Oregon, United States
Abington Neurological Associates Ltd - Willow Grove, Pennsylvania, United States
University of Texas Health Science Center at San Antonio - San Antonio, Texas, United States
University of Washington Medical Center - Seattle, Washington, United States
Novartis Investigative Site - Aberdeen, United Kingdom
Novartis Investigative Site - Amsterdam, Netherlands
Novartis Investigative Site - Berlin, Germany
Novartis Investigative Site - Bialystok, Poland
Novartis Investigative Site - Brno, Czechia
Novartis Investigative Site - Incheon, South Korea
Novartis Investigative Site - Incheon, South Korea
Novartis Investigative Site - London, United Kingdom
Novartis Investigative Site - London, United Kingdom
Novartis Investigative Site - London, United Kingdom
Novartis Investigative Site - Mölndal, Sweden
Novartis Investigative Site - München, Germany
Novartis Investigative Site - Newcastle upon Tyne, United Kingdom
Novartis Investigative Site - Oświęcim, Poland
Novartis Investigative Site - Paris, France
Novartis Investigative Site - Prague, Czechia
Novartis Investigative Site - Salford, United Kingdom
Novartis Investigative Site - Seoul, South Korea
Novartis Investigative Site - Shanghai, China
Novartis Investigative Site - Southampton, United Kingdom
Novartis Investigative Site - Stockholm, Sweden
Novartis Investigative Site - Valencia, Spain
Novartis Investigative Site - Wroclaw, Poland
Novartis Investigative Site - Ōbu, Aichi-ken, Japan
Novartis Investigative Site - Fujioka, Gunma, Japan
Novartis Investigative Site - Toulouse, Haute Garonne, France
Novartis Investigative Site - Seoul, Korea, South Korea
Novartis Investigative Site - Edinburgh, Lothian, United Kingdom
Novartis Investigative Site - Pamplona, Navarre, Spain
Novartis Investigative Site - Camperdown, New South Wales, Australia
Novartis Investigative Site - Kogarah, New South Wales, Australia
Novartis Investigative Site - London, Ontario, Canada
Novartis Investigative Site - North York, Ontario, Canada
Novartis Investigative Site - Ottawa, Ontario, Canada
Novartis Investigative Site - Toronto, Ontario, Canada
Novartis Investigative Site - Toronto, Ontario, Canada

Showing 60 of 74 listed sites. See the official record for the complete list.

Read the full protocol, contacts and eligibility on ClinicalTrials.gov →