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AC Immune

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Alzheimer

AC Immune

Leeftijd icoon
50 - 74 years (M / F)
Diagnose icoon
Mild Cognitive Impairment (MCI) due to Alzheimer's, mild-stage Alzheimer's
Duratie onderzoek
1,5 years
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 Ib / IIa, multicenter, randomized, double-blind, placebo-controlled study.

The target group for this research is men and women aged 50 to 74 with a mild cognitive impairment based on Alzheimer’s or a mild form of Alzheimer’s.

The study examines the safety, tolerability, and immune response of a vaccine against Tau protein. The vaccine has been developed against Alzheimer’s disease.

The research is being carried out in the Brain Research Center (locations Amsterdam and Den Bosch) in collaboration with the Amsterdam UMC – location VUmc and the Jeroen Bosch Hospital. The research is divided into three stages.

This research is commissioned by AC Immune.

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

Screening – Selection

During three visits in a maximum period of 30 days, 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 includes a physical and neurological examination, memory tests, questionnaires, blood tests, a heart film, an MRI scan of the brain, and a spinal tap.

Treatment

In this study, the study drug in different doses is compared to a placebo (‘fake’ drug). The chance that you will receive the study drug compared to the placebo is 3:1.

The first administration of the vaccine will take place in the hospital (VUmc/Jeroen Bosch hospital), after which you will be admitted for 24 hours for observation. After administration of the medication, blood tests, checks of vital functions, and physical and neurological examinations are performed. The follow-up vaccinations will be administered at the Brain Research Center, after which you will remain for observation for 4 hours. You will be called after 2 to 3 days, asking about your health and any side effects. After the vaccinations, there will be various follow-up visits, which will include checking for side effects, two more spinal taps, blood tests, and physical and neurological examinations.

Follow-up

Follow-up visits take place 17 and 24 weeks after the completion of the treatment period. Among other things, side effects will be checked and vital signs, a heart film, and an MRI scan will take place.

A total of approximately 14 visits take place over a period of 74 weeks, of which 1 overnight stay at the VUmc/Jeroen Bosch Hospital and the rest at the Brain Research Center and MRI center Amsterdam/MRI of the Jeroen Bosch Hospital.

Who can participate?

  • You are diagnosed with mild Alzheimer’s disease
  • You are a man or woman aged 50 to 74
  • You have someone close to you/a caregiver who can accompany you during a few visits to the research center and answer questions about your health and functioning, among other things.
  • Medication such as rivastigmine or galantamine is allowed when the dose has been stable for at least 3 months.

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

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