Study of ABBV-1758 Safety and Effects by Injection in People Aged 50 to 90 With Alzheimers Disease

What this Trial Is About

Alzheimers disease AD is a progressive and irreversible neurological disorder that commonly causes dementia in older adults. This research aims to evaluate the safety, effects, and how the body processes ABBV-1758, an investigational drug developed to treat Alzheimers disease. The study is conducted in three stages, including dose escalation and expansion phases, involving approximately 210 participants across the United States, China, and Japan. Participants will receive intravenous IV or subcutaneous SC ABBV-1758 or placebo injections once every four weeks for a period of 24 weeks. The study includes a Follow-up Period lasting 12 weeks after treatment, and participants may opt to join a 12-month blinded Extension Period based on specific brain imaging results. Randomization assigns participants to different doses or placebo groups throughout the three stages, ensuring a 41 chance of receiving ABBV-1758 versus placebo. During the trial, participants will attend regular visits at hospitals or clinics for medical assessments, blood tests, and questionnaires to monitor safety and treatment effects. Researchers will measure outcomes such as adverse events, changes in laboratory tests, brain amyloid levels, and other vital signs over approximately 40 weeks. The study emphasizes monitoring brain imaging abnormalities and drug levels in the body to better understand ABBV-1758s impact.

A Study to Assess the Safety and Effects of ABBV-1758 Following Subcutaneous or Intravenous Injections in Participants With Alzheimer's Disease