A Clinical Trial of Trontinemab in Participants With Early Symptomatic Alzheimer's Disease

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Hoffmann-La Roche
Study ID
NCT07170150
Phase
PHASE3
Status
Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
50 Years - 90 Years
Healthy Volunteers
Not accepted

Interventions

  • Trontinemab — DRUG
    Participants will receive IV trontinemab
  • Placebo — OTHER
    Participants will receive IV placebo

Study Details

The purpose of this study is to assess the efficacy and safety of trontinemab in participants with early symptomatic Alzheimer's disease (AD) (mild cognitive impairment \[MCI\] to mild dementia due to AD).

Key Dates

Start date
Nov 12, 2025
Status verified
Jun 2026
Primary completion
Jun 7, 2028
Completion
Jun 7, 2028

Study Design

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

Arms

  • Experimental: Trontinemab
    Participants will receive intravenous (IV) trontinemab.
  • Placebo Comparator: Placebo
    Participants will receive IV placebo.

Primary Outcome Measure

Change from baseline to Week 72 in Clinical Dementia Rating, Sum of Boxes (CDR-SB) [ Time Frame: Baseline - Week 72 ]

Central Contacts

  • Reference Study ID Number: WN45447 https://forpatients.roche.com/
    888-662-6728
  • Fastest response: use the inquiry form. No email attachments. https://www.gene.com/contact-us/submit-medical-inquiry

Locations (33)

FacilityCityStateZIPSite coordinators
Banner Alzheimer?s InstitutePhoenixArizona85006-
Sun Valley Research Center, Inc.ImperialCalifornia92251-
Healthy Brain ClinicLong BeachCalifornia90804-
Oakland ClinicalOaklandCalifornia94609-
Riverside ClinicalRiversideCalifornia92506-
Cenexel California Neuroscience Research, LLCSherman OaksCalifornia91403-
Yale UniversityNew HavenConnecticut06510-
JEM Research LLCAtlantisFlorida33462-
K2 Medical Research-Winter GardenClermontFlorida34711-
Visionary Investigators Network- Neurology AventuraMiamiFlorida33133-
Charter Research - Winter Park/OrlandoOrlandoFlorida32803-
Conquest Research - Lake NonaOrlandoFlorida32832-
Alzheimer's Research and Treatment CenterStuartFlorida34996-
CenExel iResearch, LLCDecaturGeorgia30030-
Center for Advanced Research & EducationGainesvilleGeorgia30501-
Great Lakes Clinical Trials Chicago d/b/a Flourish Research AndersonvilleChicagoIllinois60640-
Adams Clinical BostonBostonMassachusetts02116-
Adams Clinical WatertownWatertownMassachusetts02472-
Quest Research InstituteFarmington HillsMichigan48334-
University of Nebraska Medical CenterOmahaNebraska68198-8440-
The Cognitive and Research Center of New JerseySpringfieldNew Jersey07081-
IMA Clinical Research - AlbuquerqueAlbuquerqueNew Mexico87109-
AD-CARE, University of Rochester Medical CenterRochesterNew York14620-
Summit Research Network Inc.PortlandOregon97210-
Flourish Research ? PhiladelphiaPlymouth MeetingPennsylvania19462-
Palmetto Clinical TrialsSummervilleSouth Carolina29485-
Gadolin Research, LLCBeaumontTexas77702-
Kerwin Medical CenterDallasTexas75216-
Re:Cognition Health - Fort WorthFort WorthTexas76104-
Mt.Olympus Medical ResearchKatyTexas77450-
El Faro Health and TherapeuticsRio Grande CityTexas78582-
Sana Research, LLCArlingtonVirginia22205-
Re:Cognition HealthFairfaxVirginia22031-

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