Trailblazer

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

A phase 2, double-blind, randomized, placebo-controlled trial of the safety, tolerability, and effectiveness of Donanemab in early-stage Alzheimer’s disease. The target population of this study is men and women between the ages of 60 and 85 who have been diagnosed with mild cognitive impairment due to Alzheimer’s disease (MCI) or Alzheimer’s disease. The research drug Donanemab is a new drug against Alzheimer’s disease. With this study, the researchers want to learn more about the safety and working mechanisms of the drug. The study drug is administered through an IV.

The research is carried out in the Brain Research Center Amsterdam, Den Bosch, and Zwolle. In total, approximately 34 visits are made to the research center over a period of 133 weeks.

This study is commissioned by Eli Lilly.

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

During a period of up to nine weeks, it will be determined whether you meet the study criteria and whether your general health allows participation in the study. If so, you can participate. The selection takes place at one of our locations and includes blood tests, physical examinations, neuropsychological tests, and questionnaires. Both an MRI scan and two types of PET scans are also made.

The treatment period has a duration of 76 weeks. In this part of the study, the study drug is compared to a placebo. The chance that you will receive the study drug compared to the placebo is 50%. Participants are randomized (randomly assigned) to one of two groups: 1400 mg Donanemab, or placebo. The study drug or placebo will be administered via an IV every 4 weeks during your visit to the Brain Research Center, for a duration of 72 weeks. No IV will be administered at the last visit of the treatment period. During the visits to the Brain Research Center, in addition to the administration of the IV, certain tests will also take place, such as blood tests, physical and neurological examinations, neuropsychological tests and questionnaires, as well as five MRI scans, four Amyloid PET scans and twice a TAU PET scan.

After the treatment period of 76 weeks, a so-called follow-up period follows. This follow-up period can last up to 48 weeks. The 4 visits take place every 12 weeks, so during these 48 weeks, you will come to the research center 4 times. During these visits, no treatment with the research drug will be done, but physical and neurological examination, blood collection, and neuropsychological examination will still be performed.

• You have a diagnosis of Mild Cognitive Impairment (MCI) or mild-stage Alzheimer’s disease.
• You are between 60 and 85 years old.
• You have someone close to you/a caregiver who can accompany you during the visits to the research center and answer questions about your health and functioning.