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

Purpose

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

  • Alzheimers Disease

Eligibility

Eligible Ages
Between 50 Years and 90 Years
Eligible Sex
All
Accepts 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

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Trontinemab 		Participants will receive intravenous (IV) trontinemab.
  • Drug: Trontinemab
    Participants will receive IV trontinemab
    Other names:
    • RO7126209
Placebo Comparator
Placebo 		Participants will receive IV placebo.
  • Other: Placebo
    Participants will receive IV placebo

Recruiting Locations

Banner Alzheimer?s Institute
Phoenix, Arizona 85006

Sun Valley Research Center, Inc.
Imperial, California 92251

Healthy Brain Clinic
Long Beach, California 90804

Oakland Clinical
Oakland, California 94609

Riverside Clinical
Riverside, California 92506

Cenexel California Neuroscience Research, LLC
Sherman Oaks, California 91403

Yale University
New Haven, Connecticut 06510

JEM Research LLC
Atlantis, Florida 33462

K2 Medical Research-Winter Garden
Clermont, Florida 34711

Visionary Investigators Network- Neurology Aventura
Miami, Florida 33133

Charter Research - Winter Park/Orlando
Orlando, Florida 32803

Conquest Research - Lake Nona
Orlando, Florida 32832

Alzheimer's Research and Treatment Center
Stuart, Florida 34997

CenExel iResearch, LLC
Decatur, Georgia 30030

Center for Advanced Research & Education
Gainesville, Georgia 30501

Great Lakes Clinical Trials Chicago d/b/a Flourish Research Andersonville
Chicago, Illinois 60640

Adams Clinical Watertown
Watertown, Massachusetts 02472

Quest Research Institute
Farmington Hills, Michigan 48334

University of Nebraska Medical Center
Omaha, Nebraska 68198-8440

The Cognitive and Research Center of New Jersey
Springfield, New Jersey 07081

AD-CARE, University of Rochester Medical Center
Rochester, New York 14620

Summit Research Network Inc.
Portland, Oregon 97210

Flourish Research ? Philadelphia
Plymouth Meeting, Pennsylvania 19462

Gadolin Research, LLC
Beaumont, Texas 77702

Kerwin Medical Center
Dallas, Texas 75216

Re:Cognition Health - Fort Worth
Fort Worth, Texas 76104

Mt.Olympus Medical Research
Katy, Texas 77450

Sana Research, LLC
Arlington, Virginia 22205

Re:Cognition Health
Fairfax, Virginia 22031

More Details

NCT ID
NCT07170150
Status
Recruiting
Sponsor
Hoffmann-La Roche

Study Contact

Reference Study ID Number: WN45447 https://forpatients.roche.com/
888-662-6728
global-roche-genentech-trials@gene.com

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ResearchMatch is funded in part by the National Institutes of Health (NIH) Clinical and Translational Science Award (CTSA) program, led by the NIH’s National Center for Advancing Translational Sciences (NCATS), grants UL1TR000445 and 1U54RR032646-01, and grant U24TR001579 from NCATS and the National Library of Medicine. The content of this website is solely the responsibility of ResearchMatch and Vanderbilt University and does not necessarily represent the official views of the NIH, NCATS, or NLM.

Vanderbilt University Medical Center