Recruiting
Phase 3

Trontinemab

Sponsor:

Hoffmann-La Roche

Code:

NCT07170150

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

NCT07170150

Start date

Nov 12, 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: WN45447 https://forpatients.roche.com/ No attachments to email below.

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

Locations

Banner Alzheimer?s Institute

Recruiting

Phoenix, Arizona, United States, 85006

Sun Valley Research Center, Inc.

Recruiting

Imperial, California, United States, 92251

Healthy Brain Clinic

Recruiting

Long Beach, California, United States, 90804

Oakland Clinical

Recruiting

Oakland, California, United States, 94609

Riverside Clinical

Recruiting

Riverside, California, United States, 92506

Cenexel California Neuroscience Research, LLC

Recruiting

Sherman Oaks, California, United States, 91403

Yale University

Recruiting

New Haven, Connecticut, United States, 06510

JEM Research LLC

Recruiting

Atlantis, Florida, United States, 33462

K2 Medical Research-Winter Garden

Recruiting

Clermont, Florida, United States, 34711

Visionary Investigators Network- Neurology Aventura

Recruiting

Miami, Florida, United States, 33133

Charter Research - Winter Park/Orlando

Recruiting

Orlando, Florida, United States, 32803

Conquest Research - Lake Nona

Recruiting

Orlando, Florida, United States, 32832

Alzheimer's Research and Treatment Center

Recruiting

Stuart, Florida, United States, 34996

CenExel iResearch, LLC

Recruiting

Decatur, Georgia, United States, 30030

Center for Advanced Research & Education

Recruiting

Gainesville, Georgia, United States, 30501

Great Lakes Clinical Trials Chicago d/b/a Flourish Research Andersonville

Recruiting

Chicago, Illinois, United States, 60640

Adams Clinical Boston

Recruiting

Boston, Massachusetts, United States, 02116

Adams Clinical Watertown

Recruiting

Watertown, Massachusetts, United States, 02472

Quest Research Institute

Recruiting

Farmington Hills, Michigan, United States, 48334

University of Nebraska Medical Center

Recruiting

Omaha, Nebraska, United States, 68198-8440

The Cognitive and Research Center of New Jersey

Recruiting

Springfield, New Jersey, United States, 07081

IMA Clinical Research - Albuquerque

Recruiting

Albuquerque, New Mexico, United States, 87109

AD-CARE, University of Rochester Medical Center

Recruiting

Rochester, New York, United States, 14620

Summit Research Network Inc.

Recruiting

Portland, Oregon, United States, 97210

Flourish Research ? Philadelphia

Recruiting

Plymouth Meeting, Pennsylvania, United States, 19462

Palmetto Clinical Trials

Recruiting

Summerville, South Carolina, United States, 29485

Gadolin Research, LLC

Recruiting

Beaumont, Texas, United States, 77702

Kerwin Medical Center

Recruiting

Dallas, Texas, United States, 75216

Re:Cognition Health - Fort Worth

Recruiting

Fort Worth, Texas, United States, 76104

Mt.Olympus Medical Research

Recruiting

Katy, Texas, United States, 77450

El Faro Health and Therapeutics

Recruiting

Rio Grande City, Texas, United States, 78582

Sana Research, LLC

Recruiting

Arlington, Virginia, United States, 22205

Re:Cognition Health

Recruiting

Fairfax, Virginia, United States, 22031

Okanagan Clinical Trials

Recruiting

Kelowna, British Columbia, Canada, V1Y 1Z9

Centricity Research

Recruiting

Halifax, Nova Scotia, Canada, B3S 1N2

Parkwood Institute Main Building

Recruiting

London, Ontario, Canada, N6C0A7

The Ottawa Memory Clinic

Recruiting

Ottawa, Ontario, Canada, K1Z 1G3

Kawartha Centre - Redefining Healthy Aging

Recruiting

Peterborough, Ontario, Canada, K9H 2P4

Sunnybrook Health Sciences Centre

Recruiting

Toronto, Ontario, Canada, M4N 3M5

St. Michael's Hospital

Recruiting

Toronto, Ontario, Canada, M5B 1W8

Genge Partners Inc.

Recruiting

Montreal, Quebec, Canada, H4A 3T2

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.