Dementia

Die Studie

• You are a healthy male or female.
• You are at least 18 and no more than 55 years old .
• You weigh between 50 and 110 kg and your Body Mass Index (BMI) is higher or equal to 18.0 and lower or equal to 32.0 kg/m². 
• You did not smoke in the 3 months prior to screening.

Note: 

• You cannot participate in the trial if you have participated in another clinical trial in the 30 days prior to the first study drug administration in this clinical trial (counting from the follow-up visit 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:

• Younger than 35 years old: you use (hormonal) contraception (for example the contraceptive pill or intra-uterine device) in combination with a condom;
• Older than or equal to 35 years old: you have a copper intrauterine device and use a condom in combination with it; no hormonal contraception is allowed;
• You have passed the menopause (no periods for at least 12 months);
• You have been sterilized or your male partner has been sterilized;
• You are only sexually active with a partner of the same sex;
• You are not sexually active according to your lifestyle.

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

• You use 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 A of the trial consists of 1 period during which you will stay in the research facility in Groningen for 6 days (5 nights), followed by 5 short visits to the research facility, and a final follow-up visit 4 weeks thereafter. The total study duration from dosing until the final follow-up visit will be approximately 85 days. 

Note: You must be available for all dates to be able to participate in this clinical trial. The location in Groningen is Van Swietenlaan 6 or Hanzeplein 1 (UMCG).

Aufwandsentschädigung

• You will receive a gross compensation of € 2904 for full participation in one of the cohorts of part A.

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