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Taking part in this study can last up to two years after joining. People will have a first visit and then follow up visits every six months, for up to five visits total. These visits may happen in person, by phone, or by video. At each visit, the study team will check overall health, seizures, medicines, hospital stays, and any problems with the implanted device. They will also review information collected by the Minder device and ask people to answer questions about mood, memory, anxiety, and quality of life. Between visits, the study doctor may review device information each month as part of regular care. Some people may be asked to come in for extra visits if needed. No new surgery is required because the device was already placed before the study.

We are doing this study to test the safety and effectiveness of the study drug, datopotamab deruxtecan (also known as dato-DXd), and find out if it is a potential option for patients with metastatic breast cancer that has spread to the brain and/or spinal cord.

The study team will collect medical record information from your hospitalization for pneumonia. You will also be asked to provide a urine (pee) sample for additional testing.

This study starts with a screening visit to see if a person can join. After that, there are thirteen study visits over about twenty weeks. During this time, participants will receive three shots of the study medicine called DISC 3045 given under the skin. All study visits include blood tests, and one visit will include two blood draws. People may also choose to stay in the study longer for another twelve weeks. If they continue, they will receive three more shots of the study medicine and have seven more study visits with blood tests.

In this study, people will be placed into one of two groups by chance. One group will receive the study medicine and the other group will receive a placebo, which has no active medicine. The study medicine is given one or two times through a small needle in the lower back into the area around the spinal cord. The medicine is designed to lower a protein that builds up in the brains of people with Alzheimer disease. Participants will stay in the research center for a few days during treatment so doctors can watch them closely. They will also need to have a study partner who can go with them to many of the study visits.

We are doing this study to find out if an investigational drug called iptacopan (the study drug) is safe and has beneficial effects for people who have generalized Myasthenia Gravis (gMG).