🇮🇪Ireland
16°C Partly Cloudy · Dublin
Live Updates
--:--:-- IST
Contributor sign in
Latest
Clinical Trials in Germany / NCT07169578
Active, not recruiting Phase 3

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

NCT07169578 · tracked via the Priya Life Science Germany tracker
Phase
Phase 3
Started
2025-09-17
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)

Trial sites (142)

FacilityCityRegionStatus
University of Alabama at Birmingham Birmingham Alabama
Banner Sun Health Research Institute Sun City Arizona
Irvine Center for Clinical Research Irvine California
Inglewood Clinicals Los Angeles California
UCSF - Memory and Aging Center San Francisco California
Syrentis Clinical Research Santa Ana California
K2 Medical Research - The Villages Lady Lake Florida
K2 Medical Research, LLC Maitland Florida
Renstar Medical Research Ocala Florida
Axiom Brain Health LLC Tampa Florida
Charter Research - Lady Lake/The Villages The Villages Florida
Alzheimer?s Research and Treatment Center Wellington Florida
Conquest Research, LLC Winter Park Florida
Alzheimer's Research and Treatment Center - Columbus Columbus Georgia
Accel Research Sites-NeuroStudies Decatur Georgia
Hawaii Pacific Neuroscience Honolulu Hawaii
RE:Cognition (Chicago) Chicago Illinois
Tandem Clinical Research, LLC Marrero Louisiana
Brigham and Womens Hospital Boston Massachusetts
Boston Center for Memory Newton Massachusetts
Washington University School of Medicine St Louis Missouri
The Cognitive and Research Center of New Jersey Ridgewood New Jersey
Basil Clinical Laurelton New York
Weill Cornell Medical College New York New York
Adams Clinical Harlem New York New York
Adams Clinical Bronx The Bronx New York
Triad Clinical Trials Greensboro North Carolina
Ohio State University Columbus Ohio
Butler Hospital Providence Rhode Island
Genesis Neuroscience Clinic Knoxville Tennessee
K2 Medical Research - Nashville Nashville Tennessee
Kerwin Research Center, LLC Dallas Texas
South Texas Research Institute - Edinburg Edinburg Texas
Re:Cognition Health - Houston Houston Texas
National Clinical Research Inc.-Richmond Richmond Virginia
Hospital Italiano CABA Argentina
Hospital das Clinicas - UFMG Belo Horizonte Minas Gerais
Hospital Moinhos de Vento Porto Alegre Rio Grande do Sul
Centro de Pesquisas Clinicas - CPCLIN São Paulo São Paulo
Richmond Clinical Trials Richmond British Columbia

+ 102 more sites — see the full list on the official registry below.

More Hoffmann-La Roche trials in Germany

Other trials for the same condition

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 NCT07169578 on ClinicalTrials.gov ↗ ← All trials in Germany