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Leeftijd icoon
55 - 80 years (M / F)
Diagnose icoon
Diagnosis of dementia due to Alzheimer's disease.
Duratie onderzoek
54 weeks
Locatie icoon
Amsterdam and Den Bosch

About this research

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

Phase II / III, randomized, double-blind, placebo-controlled study. With this study, the researchers want to learn more about the safety and working mechanisms of the drug COR388. The research drug COR388 HCI 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 via capsule (orally). The research is carried out in the Brain Research Center Amsterdam and Den Bosch. In total, approximately 15 visits are made to the research center over a period of 54 weeks.

This study is commissioned by Cortexyme.

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

Screening – Selection

During a maximum period of six 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 in the study. The selection consists of, among other things, blood tests, physical examinations, memory tests, questionnaires, an MRI scan (with contraindication, a CT scan can be used), and a spinal tap.

Treatment

In this study, the study drug is compared with a placebo. The chance that you will receive the study drug compared to placebo is 66%. Participants may be randomized into one of three groups: 40 mg COR388 HCl, 80 mg COR388 HCl, or placebo. You must take the capsule yourself twice a day for a duration of 48 weeks. Appointments will be made with you, on which you should come to our center for check-ups (inquiries about side effects and medication use) and physical and neurological examinations and neuropsychological examinations will take place.

Follow-up

After completing the treatment phase, participants will be followed for up to six weeks and will return to the center once for a final check-up. During this last check-up visit, questionnaires and tests will be taken for your memory, among other things, and a final blood test, physical examination and a heart film will be performed.

Who can participate?

  • You have a diagnosis of dementia due to Alzheimer’s disease.
  • You are between 55 and 80 years old.
  • Use of Alzheimer’s medication is allowed, provided it is stable for a period of 90 days prior to screening.
  • You have a family carer who can accompany you during the visits to the research center and answer questions about your health and functioning.

Take action against Alzheimer’s. Sign up to participate.

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