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PRA-RPUBHN07-0D1UGT

Alzheimer’s disease

  • M/F
  • 18 - 55 years old
  • Healthy

Clinical trial of a new compound that is being developed for the treatment of Alzheimer’s disease

Register without obligation

Very positive, professional, and a pleasant location.

Analiza

Deelnemer ICON

Register without obligation

Find out if you qualify for this trial

  • You are a healthy male or female
  • You are between 18 and 55 years old
  • You weigh more than 50 kg
  • Your Body Mass Index (BMI) is between 18 and 30 kg/m2

Good to know about this trial

  • You can participate as a light smoker (max. 5 sigarettes per day).
  • The research consists of 2 short stays.
  • One of the compounds that is being researched is already in use by patients. 

 

How does it work

How does it work?

  1. 1.

    Registering

    Register for the trail and the group you choose. After your registration, call ICON to discuss the study and make an appointment for your medical examination. This can be done from the next working day after your registration.

  2. 2.

    Medical screening

    If you meet the requirements of the trial, then a medical screening takes place at our screening center in Groningen or Utrecht.

  3. 3.

    The trial

    The clinical trial is conducted at ICON's research center in Groningen. There you will eat, sleep and stay during the trial.

  4. 4.

    Follow-up & Compensation

    A follow-up screening always takes place after the trial. You will receive the compensation for your participation, within 30 days.

Read more

Study groups

Register without obligation for the group of your preference

  • Group 1

    • 6 up to and including 11 June
    • 16 up to and including 29 June

    Period(s) of stay
    1 x 6 days, 1 x 14 days

    • 6 up to and including 11 June
    • 16 up to and including 29 June

    • 13 June
    • 1 July
    • 3 July

    Visit(s) (3 days)

    • 13 June
    • 1 July
    • 3 July

    • €5371,-

    Compensation

    • €5371,-

    The follow-up will be on July 5, 8 or 9.

    Follow-up

    The follow-up will be on July 5, 8 or 9.

    Full

  • Group 2

    • 13 up to and including 18 June
    • 23 June up to and including 6 July

    Period(s) of stay
    1 x 6 days, 1 x 14 days

    • 13 up to and including 18 June
    • 23 June up to and including 6 July

    • 20 June
    • 8 July
    • 10 July

    Visit(s) (3 days)

    • 20 June
    • 8 July
    • 10 July

    • €5371,-

    Compensation

    • €5371,-

    The follow-up will be on 12th, 15th or 16th of July. 

    Follow up

    The follow-up will be on 12th, 15th or 16th of July. 

    Full

THE RESEARCH PHYSICIAN ABOUT THIS RESEARCH

Additional information

  • The study compound is being developed for the treatment of Alzheimer’s disease.
  • In this clinical trial, we investigate whether an approved compound that is already available on the market (itraconazole) has an influence on the way the  study compound is processed and eliminated by the body. Furthermore, we investigate how well the administration of both compounds is tolerated when they are used by healthy participants.
  • The study consists of 2 periods. In the first period you will receive a single dose of the study compound. This will be administered in the form of a capsule to swallow. In the second period you will receive a single dose of the study compound, and you will also receive Itraconazole. This will also be administered in the form of a capsule to swallow. You will receive Itraconazole once daily for 12 days. Itraconazole is used to treat fungal infections.
  • You can only participate in one group of this trial.

WHO CAN PARTICIPATE IN THIS TRIAL?

Target group

  • You are a healthy male or female.
  • You are at least 18 and at most 55 years old.
  • Your Body Mass Index (BMI) is at least 18 and at most 30 kg/m2 (inclusive). 
  • Both non-smokers and light smokers or occasional smokers (maximum of 5 cigarettes per day) are allowed to participate in this clinical trial. 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 the 90 days prior to the first compound administration in this clinical trial (counting from the follow-up visit).
  • 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 breastfeeding and meet one of the following conditions:

  • You are using an intra-uterine device in combination with a condom;
  • 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 not sexually active according to your lifestyle;
  • You are only sexually active with a partner of the same sex.

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

  • You are using a condom with your female partner;
  • 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.

WHO CAN PARTICIPATE?

Compensation

  • You will receive a gross compensation of € 5371 for participation in one of the groups of the study.
  • 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.

HOW LONG DOES THIS RESEARCH TAKE

Trial Period

The trial consists of 2 periods during which you will stay in the research facility in Groningen (location van Swietenlaan 6). The first period consists of 6 days (5 nights), followed by one short visit. The second period consists of 14 days (13 nights), followed by two short visits. The follow-up visit will take place 2 to 6 days after your last short visit.

Note: You must be available for all dates to be able to participate in this clinical trial. The current dates of the clinical trial will be published on our website.

Veelgestelde vragen

Je mag maximaal 4 keer per jaar deelnemen aan een onderzoek. Tussen twee onderzoeken moeten minstens 30 dagen zitten. Voor sommige onderzoeken geldt een langere wachttijd.

Je deelname aan geneesmiddelenonderzoek is altijd vrijwillig. Je mag dus op elk moment besluiten om te stoppen. Soms ben je genoodzaakt om te stoppen. Bijvoorbeeld vanwege familieomstandigheden, of als de arts besluit dat dat voor jouw gezondheid beter is. Als je stopt, bekijken we op welk deel van de vergoeding je recht hebt. Wel zo eerlijk!

Je kunt tijdens het onderzoek last krijgen van milde klachten als hoofdpijn of misselijkheid. Dat kan door het geneesmiddel komen. Maar het kan ook komen doordat je voor het onderzoek bijvoorbeeld nuchter moet blijven. Die bijwerkingen zijn vervelend, maar gelukkig niet gevaarlijk.

Voordat een geneesmiddel op mensen mag worden getest, is het al uitgebreid onderzocht in een laboratorium. Daardoor kunnen we goed voorspellen welke bijwerkingen je eventueel kunt krijgen en kunnen we je daarop voorbereiden. Het komt dus bijna nooit voor dat deelnemers last krijgen van onverwachte bijwerkingen. Een allergische reactie op het middel komt gemiddeld bijvoorbeeld één keer per jaar voor.

Als je meedoet aan een onderzoek waarvoor je langer dan 10 dagen in het onderzoekscentrum verblijft, is het soms mogelijk om (in overleg) bezoek te ontvangen.

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