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NCT07169578 | RECRUITING | Alzheimers Disease

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

Hoffmann-La Roche

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).

Condition or disease

Alzheimers Disease

Intervention/treatment

Trontinemab

Placebo

Phase

PHASE3

Study Type : INTERVENTIONAL
Estimated Enrollment : 800 participants
Masking : QUADRUPLE
Primary Purpose : TREATMENT
Official Title : A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Efficacy and Safety Study of Trontinemab in Participants With Early Symptomatic Alzheimer's Disease (MCI to Mild Dementia Due to AD)
Actual Study Start Date : 2025-10-27
Estimated Primary Completion Date : 2028-07-25
Estimated Study Completion Date : 2028-11-07

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 50 Years to 90 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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
A Study of Trontinemab in Participants With Early Symptomatic Alzheimer's Disease

Location Details

NCT07169578

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, California

Irvine Center for Clinical Research

Irvine, California, United States, 92614

RECRUITING

United States, New York

Basil Clinical

Laurelton, New York, United States, 11413-2016

RECRUITING

Canada, Ontario

Toronto Memory Program

Toronto, Ontario, Canada, Make the most correct