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

RecruitingPhase 3

Sponsor: Hoffmann-La Roche

Conditions: Alzheimers Disease

Interventions: Trontinemab, Placebo

Countries: United States, Argentina, Brazil, Canada, China, France, Germany, Italy

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 overview

Sex: ALL

Age: 50 Years to 90 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility 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

Locations (143)

Birmingham, Alabama, United States
Sun City, Arizona, United States
Irvine, California, United States
Los Angeles, California, United States
San Francisco, California, United States
Santa Ana, California, United States
Lady Lake, Florida, United States
Maitland, Florida, United States
Ocala, Florida, United States
Tampa, Florida, United States
The Villages, Florida, United States
Wellington, Florida, United States
Winter Park, Florida, United States
Columbus, Georgia, United States
Decatur, Georgia, United States
Honolulu, Hawaii, United States
Chicago, Illinois, United States
Marrero, Louisiana, United States
Boston, Massachusetts, United States
Newton, Massachusetts, United States
St Louis, Missouri, United States
Ridgewood, New Jersey, United States
Laurelton, New York, United States
New York, New York, United States
New York, New York, United States
The Bronx, New York, United States
Greensboro, North Carolina, United States
Columbus, Ohio, United States
Providence, Rhode Island, United States
Knoxville, Tennessee, United States
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