Recruiting
Phase 3

Trontinemab

Sponsor:

Hoffmann-La Roche

Code:

NCT07169578

Conditions

Alzheimers Disease

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Not accepted

Interventions

Trontinemab

Placebo

Study Details

Brief summary:

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).

Conditions

Alzheimers Disease

Study ID

NCT07169578

Start date

Sep 17, 2025

Status verified date

Aug, 2026

Completion date

Jun 7, 2028

Anticipated

Primary completion date

Jun 7, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Willingness and ability to complete all aspects of the study (including MRI, clinical genotyping, and PET imaging or CSF as applicable) for the duration of the study. The participant should be capable of completing assessments either alone or with the help of the study partner
  • Adequate visual and auditory acuity, in the investigator's judgment, sufficient to perform the neuropsychological testing (eyewear and hearing aids are permitted)
  • Evidence of AD pathological process, as confirmed on amyloid PET scan. A CSF tau181/Aβ42 ratio may be used as an alternative option if amyloid PET is not available
  • Probable AD dementia or MCI due to AD, also known as an Alzheimer's clinical syndrome clinical Stage 3 or Stage 4
  • Screening MMSE score ≥ 22 and CDR-GS of 0.5 or 1.0
  • Participant- and/or Informant-reported history of cognitive decline with gradual onset and progression over the last 1 year before screening
  • A Repeatable Battery for the Assessment of Neuropsychological Status Delayed Memory Index (RBANS DMI) score of 85 or order
  • Availability of a "study partner" as defined by the protocol

Exclusion Criteria:

  • Any evidence of a condition other than AD that may affect cognition
  • History or presence of clinically significant cerebrovascular disease
  • History of severe, clinically significant (persistent neurologic deficit or structural brain damage) central nervous system (CNS) trauma
  • History or presence of clinically significant intracranial mass
  • MRI evidence of significant cerebral abnormalities or inability to tolerate MRI procedures or contraindication to MRI
  • Any other medical conditions (e.g., cardiovascular, hepatic, renal disease) which are not stable and adequately controlled or which in the opinion of the investigator could affect the participant's safety in the study or interfere with the study assessments
  • History of malignancy with the following exceptions: if considered to be cured; malignancies with a negligible risk of metastasis or death

Study Design

Enrollment

800 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Trontinemab

Participants will receive intravenous (IV) trontinemab.

placebo comparator: Placebo

Participants will receive IV placebo.

Interventions

Trontinemab

Participants will receive IV trontinemab.

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 and Locations

Central contacts

Reference Study ID Number: WN45443 https://forpatients.roche.com/ No attachments to email below.

888-662-6728global-roche-genentech-trials@gene.com

Locations

University of Alabama at Birmingham

Recruiting

Birmingham, Alabama, United States, 35233

Banner Sun Health Research Institute

Recruiting

Sun City, Arizona, United States, 85351

Irvine Center for Clinical Research

Recruiting

Irvine, California, United States, 92614

Inglewood Clinicals

Recruiting

Los Angeles, California, United States, 90056

UCSF - Memory and Aging Center

Recruiting

San Francisco, California, United States, 94158

Syrentis Clinical Research

Recruiting

Santa Ana, California, United States, 92705

K2 Medical Research - The Villages

Recruiting

Lady Lake, Florida, United States, 32159

K2 Medical Research, LLC

Recruiting

Maitland, Florida, United States, 32751

Renstar Medical Research

Recruiting

Ocala, Florida, United States, 34470

Axiom Brain Health LLC

Recruiting

Tampa, Florida, United States, 33609

Charter Research - Lady Lake/The Villages

Recruiting

The Villages, Florida, United States, 32162

Alzheimer?s Research and Treatment Center

Recruiting

Wellington, Florida, United States, 33414

Conquest Research, LLC

Recruiting

Winter Park, Florida, United States, 32789

Alzheimer's Research and Treatment Center - Columbus

Recruiting

Columbus, Georgia, United States, 31904

Accel Research Sites-NeuroStudies

Recruiting

Decatur, Georgia, United States, 30030

Hawaii Pacific Neuroscience

Recruiting

Honolulu, Hawaii, United States, 96817

RE:Cognition (Chicago)

Recruiting

Chicago, Illinois, United States, 60611

Tandem Clinical Research, LLC

Recruiting

Marrero, Louisiana, United States, 70072

Brigham and Womens Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Boston Center for Memory

Recruiting

Newton, Massachusetts, United States, 02459

Washington University School of Medicine

Recruiting

St Louis, Missouri, United States, 63110

The Cognitive and Research Center of New Jersey

Recruiting

Ridgewood, New Jersey, United States, 07450

Basil Clinical

Recruiting

Laurelton, New York, United States, 11413-2016

Weill Cornell Medical College

Recruiting

New York, New York, United States, 10021

Adams Clinical Harlem

Recruiting

New York, New York, United States, 10029

Adams Clinical Bronx

Recruiting

The Bronx, New York, United States, 10461

Triad Clinical Trials

Recruiting

Greensboro, North Carolina, United States, 27410

Ohio State University

Recruiting

Columbus, Ohio, United States, 43221

Butler Hospital

Recruiting

Providence, Rhode Island, United States, 02906

Genesis Neuroscience Clinic

Recruiting

Knoxville, Tennessee, United States, 37909

K2 Medical Research - Nashville

Recruiting

Nashville, Tennessee, United States, 37204

Kerwin Research Center, LLC

Recruiting

Dallas, Texas, United States, 75231

South Texas Research Institute - Edinburg

Recruiting

Edinburg, Texas, United States, 78539

Re:Cognition Health - Houston

Recruiting

Houston, Texas, United States, 77030

National Clinical Research Inc.-Richmond

Recruiting

Richmond, Virginia, United States, 23294

Richmond Clinical Trials

Recruiting

Richmond, British Columbia, Canada, V6V 2L1

Baycrest Academy for Research and Education

Recruiting

North YORK, Ontario, Canada, M6A 2E1

Toronto Memory Program

Recruiting

Toronto, Ontario, Canada, M3B 2S7

Centricity East York

Recruiting

Toronto, Ontario, Canada, M4G 3E8

Toronto Western Hospital

Recruiting

Toronto, Ontario, Canada, M5T 2S8

Clinique Memoire de Montreal

Recruiting

Montreal, Quebec, Canada, H2X 3B9

Alpha Recherche Clinique

Recruiting

Québec, Canada, G3K 2P8

More Information

Sponsor

Hoffmann-La Roche

Last update posted

Aug 6, 2026

Last verified

Aug, 2026

Keywords

  • Early Alzheimers Disease
  • Mild Cognitive Impairment
  • Mild Dementia

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Hoffmann-La Roche on 2026-08-06.