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RECRUITINGPhase 3INTERVENTIONAL

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

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)

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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).

Who May Be Eligible (Plain English)

Who May Qualify: - 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 Who Should NOT Join This Trial: - 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 ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

DRUG

Trontinemab

Participants will receive IV trontinemab

OTHER

Placebo

Participants will receive IV placebo

Locations (20)

Banner Alzheimer?s Institute
Phoenix, Arizona, United States
Sun Valley Research Center, Inc.
Imperial, California, United States
Healthy Brain Clinic
Long Beach, California, United States
Oakland Clinical
Oakland, California, United States
Riverside Clinical
Riverside, California, United States
Cenexel California Neuroscience Research, LLC
Sherman Oaks, California, United States
Yale University
New Haven, Connecticut, United States
JEM Research LLC
Atlantis, Florida, United States
K2 Medical Research-Winter Garden
Clermont, Florida, United States
Visionary Investigators Network- Neurology Aventura
Miami, Florida, United States
Charter Research - Winter Park/Orlando
Orlando, Florida, United States
Conquest Research - Lake Nona
Orlando, Florida, United States
Alzheimer's Research and Treatment Center
Stuart, Florida, United States
CenExel iResearch, LLC
Decatur, Georgia, United States
Center for Advanced Research & Education
Gainesville, Georgia, United States
Great Lakes Clinical Trials Chicago d/b/a Flourish Research Andersonville
Chicago, Illinois, United States
Adams Clinical Watertown
Watertown, Massachusetts, United States
Quest Research Institute
Farmington Hills, Michigan, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
The Cognitive and Research Center of New Jersey
Springfield, New Jersey, United States