Phase 1b2 Study of ACI-24.060 to Evaluate Safety and Effects in Prodromal Alzheimers Disease and Adults with Down Syndrome

What this Trial Is About

Researchers are evaluating the safety, tolerability, immune response, and pharmacodynamic effects of ACI-24.060 in people with prodromal Alzheimers disease and adults with Down syndrome who do not have dementia. This phase 1b2 study is divided into two parts Part 1 focuses on subjects with prodromal Alzheimers disease and includes subparts 1a and 1b, while Part 2 involves participants with Down syndrome. The study aims to better understand how ACI-24.060 affects these populations by comparing different doses and placebo over time. Participants receive various doses of ACI-24.060 or placebo at scheduled times over periods of 48 to 74 weeks depending on their group. In Part 1, those with prodromal Alzheimers disease are assigned to receive placebo or one of several doses of ACI-24.060, some with an additional adjuvant, over 48 to 74 weeks. Part 2 involves adults with Down syndrome who receive placebo or different doses of ACI-24.060 over 74 weeks, with options for dose adjustments based on prior testing in Part 1. The study is randomized and double-blinded to compare responses across groups. During the study, participants undergo safety monitoring including physical and neurological exams, MRI scans, and assessments of suicidal thoughts or behavior using the Columbia-Suicide Severity Rating Scale. Blood samples are taken to measure antibody levels against beta-amyloid. Researchers also evaluate cognitive and clinical measures relevant to Alzheimers disease and Down syndrome. The study lasts up to 100 weeks including screening and follow-up, with careful tracking of side effects and immune responses to understand the treatments effects over time.

A Study to Assess the Effects of ACI-24.060 in Alzheimer's Disease and in Down Syndrome (ABATE Study)