Die Studie

Clinical trial of a new compound that is being developed for the treatment of dementia.

  • You are a healthy male or female.
  • You are at least 18 and at most 55 years old.
  • Your weight is at least 50 kg for males, and 45 kg for females. Your Body Mass Index (BMI) is at least 18.0 and not higher than 30.9 kg/m2. 
  • Both non-smokers and light smokers or occasional smokers are allowed to participate in this clinical trial (maximum of 5 cigarettes per day). During your stay in our research facility you are not allowed to smoke.

Note:

  • You cannot participate in the trial if you have participated in another clinical trial in 3 months prior to the first compound administration in this clinical trial (counting from the last dosing of the previous trial).
  • To determine if you are suitable to participate in this trial, you will undergo a medical screening. Depending on availability, this can be performed in Groningen or in Utrecht.

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

  • You have passed the menopause (no periods for at least 12 months);
  • You have been sterilized.

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

  • You are using a condom in combination with an additional contraception method used by your female partner;
  • You have been sterilized or your female partner is sterilized or has passed the menopause (no periods for at least 12 months);
  • You are not sexually active according to your lifestyle;
  • You are only sexually active with a partner of the same sex

Zeitraum

  • Part 1: The trial consists of 1 period during which you will stay in the research facility in Groningen (location van Swietenlaan 6) for 6 days (5 nights), followed by 3 short visits. The follow-up visit will take place 1 to 6 days after your last departure from the research facility.
  • Part 2: The trial consists of 1 period during which you will stay in the research facility in Groningen (location van Swietenlaan 6) for 19 days (18 nights). The follow-up visit will take place 2 to 8 days after your departure from the research facility.
  • Part 3: The trial consists of 1 period during which you will stay in the research facility in Groningen (location van Swietenlaan 6) for 27 days (26 nights). The follow-up visit will take place 2 to 8 days after your departure from the research facility.
  • Part 4: The trial consists of 1 period during which you will stay in the research facility in Groningen (location van Swietenlaan 6) for 24 days (23 nights). The follow-up visit will take place 2 to 8 days after your departure from the research facility.

 

Group 2  
period of stay  
  • 24 März up to and including 11 April
 
follow-up between 15 and 19 April 2024

 

Group 3  
period of stay  
  • 11 April up to and including 7 Mai
 
follow-up The follow-up appointment can take place on 9,10,13,14 of May 15 2024.

 

Group 4  
period of stay  
  • 7 up to and including 30 Mai
 
follow-up Follow up between 03rd and 07th of June 2024

Note: You must be available for all dates to be able to participate in this clinical trial. 

Aufwandsentschädigung

  • Voor deelname in deel B krijg je een bruto vergoeding van €4467,-.
  • Voor deelname in deel C krijg je een bruto vergoeding van €6203,-.
  • Voor deelname in deel D krijg je een bruto vergoeding van €5552,-.

Travel expenses will be reimbursed based on the distance traveled (€ 0.21 net per kilometer) with a minimum of € 13 and a maximum of € 176.40 (840 kilometers) per round trip, regardless of the mode of transportation