🇮🇪Ireland
16°C Partly Cloudy · Dublin
Live Updates
--:--:-- IST
Writer Login
Latest
Clinical Trials in the UK / NCT07170150
Recruiting Phase 3

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

NCT07170150 · tracked via the Priya Life Science UK tracker
Sponsor
Hoffmann-La Roche
Phase
Phase 3
Started
2025-11-12
Last updated
2026-08-06

Condition(s) studied

Alzheimers Disease

Investigational drug(s) / intervention(s)

TrontinemabPlacebo

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)

Trial sites (150)

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

+ 110 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 the UK