Die Studie

  • You are a healthy male or female
  • You are between 45 and 70 years old
  • Your Body Mass Index (BMI) is between 18 and 32 kg/m2.
  • Both non-smokers and light smokers or occasional smokers are allowed to participate in this clinical trial. However, smoking is not allowed during your stay in the research facility

Note:

  • You cannot participate in the trial if you have participated in another clinical trial in the 90 days prior to the first administration in this clinical trial (counting from the follow-up visit). For some trials this will be 6 months, this will be discussed during your telephone screening. 
  • For this trial, you cannot (have) receive(d) a COVID-19 vaccine within 6 weeks prior to the start and during this trial.
  • Part 2 / 3: To determine if you are eligible to participate in this trial, you will first undergo a medical screening at our screening center in Groningen or Utrecht. The medical screening for these parts consists of two separate visits. After the regular medical screening at ICON there will be an additional visit to perform a MRI scan. This is not applicable to all participants of part 3. Only the participants who will undergo CSF sampling need a MRI-scan.

As a female you can only participate if you are not pregnant and not breast feeding and meet one of the following conditions:

  • You are using a copper intra-uterine device in combination with a condom;
  • You have passed the menopause (no menses for at least 12 months);
  • You have been sterilized with one of the following methods: hysterectomy, fallopian tube removal or ovary removal;
  • You have been sterilized by tubal ligation and you are using a condom;
  • Your male partner has been sterilized and you are using a condom;
  • You have been sterilized or your male partner has been sterilized and you are using a condom;
  • You are not heterosexually active according to your lifestyle

As a male you can only participate if you meet one of the following conditions:

  • You are using a condom in combination with a contraception method used by your female partner;
  • You have been sterilized and you are using a condom
  • Your female partner is sterilized by means of a hysterectomy, fallopian tube removal or ovary removal or is postmenopausal;
  • Your female partner is sterilized by means of tubal ligation and you are using a condom;
  • You are not heterosexually active according to your lifestyle.

 

Zeitraum

  • The trial consists of 1 period during which you will stay in the research facility in Groningen, UMCG unit,  for 5 days 4 nights), followed by 1 short visit. The follow-up visit will take place 2 - 6 days after your short visit.

PLEASE NOTE: You must be available for all dates to be able to participate in this trial. These are the currently planned dates; however, these may be subject to change.

 

Group B2a  
5 days stay  
  • 5 Jun 2022 up to and including 9 Jun 2022
 
short visit  
  • 11 Jun 2022
 
follow-up  
  • by appointment between 13 Jun 2022 up to and including 17 Jun 2022
 

 

Group B2b  
5 days stay  
  • 8 Jun 2022 up to and including 12 Jun 2022
 
short visit  
  • 14 Jun 2022
 
follow-up  
  • by appointment between 16 Jun 2022 up to and including 20 Jun 2022
 

Aufwandsentschädigung

  • You will receive a gross compensation of € 2275 for participation in one of the groups of part 2.

Travel expenses will be reimbursed based on the distance traveled (€ 0,19 net per kilometer) with a minimum of € 12 and a maximum of € 160 (840 kilometers) per round trip, regardless of the mode of transportation.