Alzheimer

Important information about this study

• You can also participate if you smoke
• The medication will be given in the form of oral capsules
• You contribute to the development of new medicines

Who can participate?

• 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.
   

Compensation

• You will receive a gross compensation of € 2240 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.

Period of stays and research

• 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.

Particularities

During the trial, fluid surrounding the brain (cerebrospinal fluid, CSF) will be collected via a lumbar puncture. A fine needle will be inserted at the space between two vertebrae in the lower back and a cannula will be inserted. A cannula is a small flexible tube that stays in place to allow for multiple sample draws. During this trial, multiple samples will be taken for over 36 hours. This procedure will be performed safely by an experienced specialist (anesthesiologist) at our location in the University Medical Center Groningen

Curious about what to expect when participating in the study? Watch the video below!