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

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Novartis Pharmaceuticals
Study ID
NCT07094516
Phase
PHASE2
Status
Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
50 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • VHB937 — BIOLOGICAL
    VHB937 solution for infusion
  • VHB937 — BIOLOGICAL
    VHB937 solution for infusion
  • Placebo — OTHER
    Solution for infusion

Study Details

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.

Key Dates

Start date
Aug 7, 2025
Status verified
May 2026
Primary completion
Sep 14, 2028
Completion
Dec 31, 2030

Study Design

Enrollment
407 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: VHB937 Low Dose
    I.V. infusions
  • Experimental: VHB937 High Dose
    I.V. infusions
  • Placebo Comparator: Placebo
    I.V. infusions

Primary Outcome Measure

Change from Baseline in the Clinical Dementia Rating scale - Sum of Boxes (CDR-SB) [ Time Frame: Baseline and Week 72 ]

Central Contacts

  • Novartis Pharmaceuticals
    1-888-669-6682
  • Novartis Pharmaceuticals
    +41613241111

Locations (24)

FacilityCityStateZIPSite coordinators
Banner Alzheimers InstitutePhoenixArizona85006
Allison Perrin (PRINCIPAL_INVESTIGATOR)
Irvine Center for Clinical ResearchIrvineCalifornia92618
+1 949 753 1663#208
Edward Zamrini (PRINCIPAL_INVESTIGATOR)
University of California San DiegoLa JollaCalifornia92037
Gabriel Leger (PRINCIPAL_INVESTIGATOR)
University of California at Los AngelesLos AngelesCalifornia90095
Marie Kim (PRINCIPAL_INVESTIGATOR)
Jem Research InstituteAtlantisFlorida33462-6608
561-968-2933
Linda Pao (PRINCIPAL_INVESTIGATOR)
Visionary Investigators NetworkAventuraFlorida33180
Jonathan Cross (PRINCIPAL_INVESTIGATOR)
K2 Medical Research LLCMaitlandFlorida32751
Sheila Baez Torres (PRINCIPAL_INVESTIGATOR)
K2 Medical Research LLCMaitlandFlorida32751
Craig Curtis (PRINCIPAL_INVESTIGATOR)
Renstar Medical ResearchOcalaFlorida34471
+1 813 345 8210
Anette Veronica Nieves (PRINCIPAL_INVESTIGATOR)
Charter Research The VillagesThe VillagesFlorida32162
Jeffrey Norton (PRINCIPAL_INVESTIGATOR)
Alzheimers Research Treatment CtrWellingtonFlorida33414
Adam Falchook (PRINCIPAL_INVESTIGATOR)
Alzheimers Research Treatment CtrWellingtonFlorida33414
561-209-2400
David Watson (PRINCIPAL_INVESTIGATOR)
Conquest ResearchWinter ParkFlorida32789
Malisa Agard (PRINCIPAL_INVESTIGATOR)
Hawaii Pacific Neuroscience LLCHonoluluHawaii96817
Kore Liow (PRINCIPAL_INVESTIGATOR)
University of Kansas HospitalFairwayKansas66205
913-588-0555
Townley Ryan (PRINCIPAL_INVESTIGATOR)
ActivMed Practices and ResearchMethuenMassachusetts01844
978-462-9571
Deborah Green-LaRoche (PRINCIPAL_INVESTIGATOR)
Citizens Memorial Hospital Neurology CLinicBolivarMissouri65613
417-841-3643
Curtis Schreiber (PRINCIPAL_INVESTIGATOR)
Lou Ruvo Center for Brain HealthLas VegasNevada89106
702-483-6025
Charles Bernick (PRINCIPAL_INVESTIGATOR)
UNC Hosp Invest Drug Serv PharmChapel HillNorth Carolina27514
Andrea Bozoki (PRINCIPAL_INVESTIGATOR)
The Ohio State UniversityColumbusOhio43210
Douglas W Scharre (PRINCIPAL_INVESTIGATOR)
Neural Net ResearchPortlandOregon97225
Michael S Mega (PRINCIPAL_INVESTIGATOR)
Abington Neurological Associates LtdWillow GrovePennsylvania19090
+1 215 957 9250 #57
David Weisman (PRINCIPAL_INVESTIGATOR)
University of Texas Health Science Center at San AntonioSan AntonioTexas78229-3900
210-567-8229
Sudha Seshadri (PRINCIPAL_INVESTIGATOR)
University of Washington Medical CenterSeattleWashington98195
Michael Rosenbloom (PRINCIPAL_INVESTIGATOR)

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