Alzheon Phase II

In order to participate in this study, you must be able to speak and read Dutch fluently.

A phase II, multicenter, study of the effects of the research drug ALZ-801 on biomarkers involved in the progression of Alzheimer’s disease.

The target population for this study is men and women aged 50 to 80 years who are diagnosed with Mild Cognitive Impairment due to Alzheimer’s disease (MCI) or mild-stage Alzheimer’s disease and who are carriers of the e4 variant of the APOE gene.

In this study, the researchers want to learn more about the effectiveness, mode of action, safety, and tolerability of ALZ-801.

The research drug PQ912 is a new drug against Alzheimer’s disease. With this study, the researchers want to learn more about the safety, workings, and effectiveness of the drug.

The research is carried out by Brain Research Center Amsterdam, Den Bosch, and Zwolle. The study consists of 3 phases with the possibility to participate in a sub-study.

This study is commissioned by Alzheon.

This text has been directly translated from the Dutch trial description as approved by the Ethical Committee.

During 2 visits during the 4-week screening period, it is determined whether you meet the study criteria and whether your general health allows participation in the study. The screening process includes blood tests, physical examinations, memory tests, questionnaires, an MRI scan, and a spinal tap.

Each participant will take the study drug once a day for the first 2 weeks and then twice a day thereafter. The duration of treatment is 104 weeks. Approximately 9 visits to the research center are planned throughout the study. During a few visits, questionnaires and neuropsychological examinations will be done, blood tests, physical examinations, and sometimes an MRI scan and/or spinal tap will take place.

Optional sub-study: Participants may choose to participate in a sub-study that assesses how the study drug changes in the blood over time. Multiple blood samples are taken during this visit for 8 hours.

After completion of the treatment phase, participants will be followed for up to 4 weeks and will return to the study center for a final check-up, including a side-effect check-up and physical examination.

• You have been diagnosed with Alzheimer’s disease and are in an early stage of the disease
• You are between 50 and 80 years old
• Medication related to Alzheimer’s disease is permitted, provided it is stable 4 weeks prior to screening
• You have someone close to you/a caregiver, who can act as a research partner, to help you and to answer questions about your health and functioning. Participation in the study will take approximately 2 years in total.