Study of Remternetug to Prevent Progression of Early Onset Alzheimers Disease in People with Genetic Risk

What this Trial Is About

Researchers are evaluating investigational study drugs for people with a genetic mutation that causes Alzheimers disease AD. The study focuses on those who either carry this mutation or are at risk but unaware of their genetic status. It aims to assess whether these drugs can prevent or slow the buildup of amyloid beta Ab2 plaques in the brain and later evaluate the impact on other Alzheimers disease biomarkers and disease progression. Participants will receive subcutaneous injections of remternetug or a matching placebo every 12 weeks during Stage 1, which is a blinded, placebo-controlled period lasting up to 4 years. After this, Stage 2 is an open-label period of 4 years where all mutation carriers will receive the active drug. Those initially on placebo will follow the same dose escalation as Stage 1, while those on active drug will continue their established dose. The design includes randomization and blinding for treatment and mutation status, with a shared placebo group across study arms. During the study, participants will undergo regular clinical and cognitive assessments, magnetic resonance imaging MRI, amyloid PET imaging, and cerebrospinal fluid CSF analysis. Researchers will monitor amyloid beta accumulation, downstream biomarkers like tau proteins and neurofilament light, and subtle cognitive changes. Safety, tolerability, and adherence will also be tracked. The total participation can last up to 8 years, including both treatment stages and follow-up assessments.

A Study of Potential Disease Modifying Treatments in Individuals at Risk for or With a Type of Early Onset AD Caused by a Genetic Mutation