Rio Grande City

Researchers are evaluating the safety and effectiveness of trontinemab in people aged 50 to 90 with early symptoms of Alzheimer's disease, ranging from mild cognitive impairment to mild dementia. This Phase III clinical trial focuses on those who show evidence of Alzheimer's pathology and have a recent history of cognitive decline. The study aims to measure changes in cognitive function over 72 weeks. Participants will be randomly assigned to receive either intravenous trontinemab or a placebo. The trial is designed as a double-blind, placebo-controlled study, meaning neither participants nor researchers know who receives the active drug or placebo. The treatment period lasts up to 72 weeks, during which participants will undergo various assessments to monitor their cognitive status and safety. During the study, participants will complete clinical tests including cognitive assessments and imaging such as MRI, PET scans, or cerebrospinal fluid analysis to confirm Alzheimer's pathology. A study partner will assist participants as needed. Researchers will track changes from the start of the study through week 72 using tools like the Clinical Dementia Rating. Safety monitoring and adherence to study procedures will also be closely observed throughout the trial.

This study is designed to identify individuals who may be eligible for future Roche clinical trials focused on Alzheimer's disease. It serves as a pre-screening step to evaluate participants based on biomarker status and cognitive performance. The study targets adults aged 50 to 90 years who have experienced memory concerns recently, with or without a diagnosis of mild cognitive impairment or dementia due to Alzheimer's disease. Participants do not receive any intervention during this study. Instead, they will have their blood drawn to measure the concentration of a biomarker called pTau217 and will undergo a cognitive assessment using the ISLT (International Shopping List Test) on the first day of participation. This process helps researchers determine potential eligibility for more extensive Alzheimer's disease trials. During the study, participants will be evaluated for memory concerns and cognitive function through blood tests and cognitive scoring. Researchers will monitor biomarker levels and cognitive scores on the first day to help assess trial eligibility. The study includes safety assessments to ensure participants can safely complete these procedures, with participation lasting for the duration of the pre-screening evaluations.