- Study Director: Julio Rojas-Martinez, MD, PhD
- Collaborators: Hoffmann-La Roche
- Status: Recruiting
- Official Study 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)
- ClinicalTrials.gov Identifier: NCT07169578
- Conditions Studied: Alzheimer’s disease
- Intervention: Trontinemab
- Phase: Phase 3
- Duration of Participation: Approximately 18 months (72 weeks)
Purpose of the Study
The purpose of this study is to assess the efficacy and safety of trontinemab in people who have early Alzheimer’s disease.
Eligibility
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 a 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 the AD pathological process, as confirmed on an 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 a 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
What to Expect
Testing: Participants will undergo IV infusions, neurological and physical examinations, MRIs, PET scans, lumbar punctures (if applicable), cognitive testing, blood and urine specimen collection, and EKGs.
The Frequency of Visits: Every 4 weeks for the first 24 weeks, then every 12 weeks for the last 48 weeks
Materials Needed Before Evaluation: Prior to participating in the trial, the patient will need a diagnosis of mild cognitive impairment (MCI) or mild dementia due to Alzheimer’s disease.
Costs: Study procedures are provided at no cost. Parking is validated at UCSF public garages for all study visits.
Contact Information
Coordinator: [email protected], 415.353.3585
Clinical Trials Nurse: Whitney Walker, MS, CNS, RN – [email protected], 415.353.7532