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Active, not recruiting Phase 3

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

NCT07170150 · tracked via the Priya Life Science Italy tracker
Phase
Phase 3
Started
2025-11-12
Last updated
2026-09-25

Condition(s) studied

Alzheimers Disease

Investigational drug(s) / intervention(s)

Trontinemab →Placebo

Trontinemab: Participants will receive IV trontinemab

Placebo: Participants will receive IV placebo

Study 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).

Eligibility

Sex
ALL
Min age
50 Years
Max age
90 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • Change From Baseline to Week 72 in Clinical Dementia Rating, Sum of Boxes (CDR-SB) — Baseline - Week 72

Trial sites (147)

FacilityCityRegionStatus
Banner Alzheimer?s Institute Phoenix Arizona
Sun Valley Research Center, Inc. Imperial California
Healthy Brain Clinic Long Beach California
Oakland Clinical Oakland California
Riverside Clinical Riverside California
Cenexel California Neuroscience Research, LLC Sherman Oaks California
Yale University New Haven Connecticut
JEM Research LLC Atlantis Florida
K2 Medical Research-Winter Garden Clermont Florida
Visionary Investigators Network- Neurology Aventura Miami Florida
Charter Research - Winter Park/Orlando Orlando Florida
Conquest Research - Lake Nona Orlando Florida
Alzheimer's Research and Treatment Center Stuart Florida
CenExel iResearch, LLC Decatur Georgia
Center for Advanced Research & Education Gainesville Georgia
Great Lakes Clinical Trials Chicago d/b/a Flourish Research Andersonville Chicago Illinois
Adams Clinical Boston Boston Massachusetts
Adams Clinical Watertown Watertown Massachusetts
Quest Research Institute Farmington Hills Michigan
University of Nebraska Medical Center Omaha Nebraska
The Cognitive and Research Center of New Jersey Springfield New Jersey
IMA Clinical Research - Albuquerque Albuquerque New Mexico
AD-CARE, University of Rochester Medical Center Rochester New York
Summit Research Network Inc. Portland Oregon
Flourish Research ? Philadelphia Plymouth Meeting Pennsylvania
Palmetto Clinical Trials Summerville South Carolina
Gadolin Research, LLC Beaumont Texas
Kerwin Medical Center Dallas Texas
Re:Cognition Health - Fort Worth Fort Worth Texas
Mt.Olympus Medical Research Katy Texas
El Faro Health and Therapeutics Rio Grande City Texas
Sana Research, LLC Arlington Virginia
Re:Cognition Health Fairfax Virginia
INECO Neurociencias Orono Rosario Santa Fe Province
CIER C. A. B. A. Argentina
Fundacion Scherbovsky Mendoza Argentina
Royal Prince Alfred Hospital Camperdown New South Wales
Southern Neurology Kogarah New South Wales
KaRa Institute of Neurological Diseases Macquarie Park New South Wales
Flinders Medical Centre Bedford Park South Australia

+ 107 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07170150 on ClinicalTrials.gov ↗ ← All trials in Italy