In order to participate in this study, you must be able to speak and read Dutch fluently.
A phase II, multicentre, double-blind, randomized, placebo-controlled study of the safety and efficacy of the drug AL002 in participants with mild to moderate Alzheimer’s disease.
This study will determine whether the study drug, called AL002, is effective and safe compared to a placebo (drug without an active ingredient) for the treatment of people with early-stage Alzheimer’s disease. With this study, the researchers want to find out more about the safety and working mechanisms of the drug. The study drug is administered by IV.
You and your research partner will come to the research center a maximum of about 32 times, during about 28 months. Each study visit lasts approximately three to six hours, depending on the procedures performed during that visit. You must fast (no food or drink, except water) prior to some blood tests.
The research is carried out in the Brain Research Center Amsterdam, Den Bosch, and Zwolle.
This study is commissioned by Alector.
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. If so, you can participate. The selection takes place at one of our locations in Amsterdam, Den Bosch, and Zwolle, and includes blood tests, physical examinations, memory tests, ECG questionnaires, Eye examination, MRI, PET scan, and a spinal tap.
In this study, the study drug is compared to a placebo. The chance that you will receive the study drug compared to placebo is 3 to 1. An IV treatment will take place every 4 weeks. In addition, agreements will be made with you when you should come to our center for check-ups (inquiries about side effects and medication use) and there will be physical and neurological examinations and neuropsychological examinations, in addition to ophthalmic examinations, spinal tap, EKGs, MRI scans. and PET scan. The duration of treatment is 48 or 96 weeks.
After completing the treatment phase, participants will be followed for up to 8 weeks and will return to the center for a follow-up. During these visits, questionnaires and tests will be taken for your memory, and among other things, blood tests, physical examinations, a PET scan, and/or a spinal tap will be performed.