Signs of mild cognitive impairment (MCI) or memory loss may include

• Losing things often
• Difficulty finding the words
• Forgetting to attend important events
• Trouble reading, writing, or holding a conversation
• Repeating the same questions or stories
• Feeling lost in familiar places
• Neglecting to pay bills

You should consider applying, or apply for a loved one, if you or your loved one are

• Experiencing signs of memory loss and may or may not have been diagnosed with mild cognitive impairment or Alzheimer’s disease
• Between 55 and 90 years old
• Have a caregiver or partner willing to assist with participation in the study and who can attend study visits with the participant

The information learned from the study may help find new treatment options in the future for people with memory problems who are then diagnosed with mild cognitive impairment or Alzheimer’s disease. Study participants will receive a full diagnostic work-up, including amyloid PET scan and MRI. Plus, completing this study may qualify you to participate in future studies, where you or your loved one could receive ACU193.

There is no cost to participate. Qualified participants do not pay for the study medication, clinic visits, overnight stays, or study-related medical procedures and laboratory tests. Participants will be compensated for the clinic visits they complete.

This study is the first time ACU193 will be given to people. As all drugs and medical procedures carry a risk of side effects, it is possible that participants may experience some discomfort or other reactions. The study staff will explain these potential risks before participants decide whether to participate in the study.

Participation is entirely voluntary. Even if you are already involved in the study, you can change your mind at any time for any reason.

In the Intercept-AD study, we are evaluating an investigational drug called ACU193. This drug is in a class called “monoclonal antibodies” and it is designed to locate and bind to proteins that build up in the brain of people with early Alzheimer’s disease. In this study, we will be evaluating how safe and tolerable ACU193 is and how it is processed by the body.

Before a potential participant decides whether to participate in the study, the study staff will review the informed consent form with them and answer any questions. Once the consent form has been signed by both the participant and caregiver, the screening period of the study begins. During this period the staff will review medical history and conduct a series of study related exams, lab tests, and scans to see whether the cause of memory changes is due to early Alzheimer’s. Participants who meet all study requirements will be asked to participate.

Participants who meet all study requirements will be randomly assigned to receive one to three doses of either ACU193 or placebo. The placebo has no active medication. In total, this study will involve 8-11 visits over a period of about 8 months. Some participants may stay overnight at the study center for 2 to 4 nights. During the visits, participants will have a safe, caring environment so caregivers can feel confident their loved ones are being treated with kindness and respect.

The chance of receiving the placebo will be 25% (1 in 4) or less.

If you are interested in learning more, please contact us at any time. You may email us at [email protected]

After finishing the study, participants may consider participating in future studies of ACU193 in which all participants could receive ACU193 at some point in the study.