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PRA-RPUBIZ41-0H1WH8

Alzheimer's disease

  • M
  • 35 - 64 years old
  • Non-smoker
  • Healthy

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

Very positive experience. You are well guided step by step through the process.

Maurice

Participant ICON

Find out if you qualify for this trial

  • You are a healthy male
  • You are between 35 and 64 years old
  • You weigh more than 50 kg
  • Your Body Mass Index (BMI) is between 18 and 30 kg/m2
  • Non-smoker

Good to know about this trial

  • You will receive the study compound once as an oral solution.  
  • The study compound has been administered to humans before. In addition, it has been extensively tested in the laboratory and on animals.

 

How does it work

How does it work?

Read more

Study groups

Register without obligation for the group of your preference

The research physician about this research

Additional information

The study compound is a new compound that may potentially be used for the treatment of Alzheimer's disease. Alzheimer’s disease is characterized by increasing impairment of brain functions and can evolve from slight impairment of memory and language to serious impairment of social interaction and daily living. To date, no drug has demonstrated the ability to reduce or halt the worsening of Alzheimer’s disease

This is a clinical trial with a radioactive (Carbon 14, 14C) labeled compound. Radioactively labeling a compound is done to be able to study how quickly and how much of the compound is absorbed, converted, and excreted through the body. The radioactivity disappears from the body at the same time as the compound through the feces, urine or breath. The compound has a radiation burden which is less than from the natural background radiation that you are exposed to in the Netherlands in one month. This background radiation is released from space, soil, air, water, food, and construction materials. To measure radioactivity levels in your body, blood, urine, and feces will be collected during the trial.

Who can participate?

Target group

  • You are a healthy male.
  • You are at least 35 and at most 64 years old.
  • Your weight at least 50 kg and your Body Mass Index (BMI) is at least 18.0 and at most 30.0 kg/m2. 
  • You do not smoke and you have not used any nicotine-containing products in the 2 months prior to the screening.
  • 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 fertile female partner (for example the pill or intrauterine device);
    • 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.

Note:

  • You cannot participate in the trial if you have participated in another clinical trial in the 60 days prior to the screening in this clinical trial (counting from the follow-up).
  • You can only participate in this trial if you have not participated in another trial with a radioactive (14C) labeled compound in the past 12 months. This condition does not apply for microdose (14C) studies. These studies have a negligible amount of radiation burden, please contact us for more information and to see if this is applicable for you.
  • 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.

WHAT IS THE COMPENSATION FOR THIS RESEARCH?

Compensation

You will receive a gross compensation of € 6393 for participation. In case there are one or more 24-hour visits needed, you will receive a gross compensation of € 263 for each visit.

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?

Period of stay and research

The trial consists of 1 period during which you will stay in the research facility in Groningen (location van Swietenlaan 6) for at least 16 days (15 nights) and at most 23 days (22 nights). The exact length of your stay is dependent on the amount of radioactivity (in your body). If the amount of radioactivity is not low enough after 23 days, you have to come back to the research facility for a maximum of 2 times for a 24-hour visit (1 night stay per 24-hour visit), until the radioactivity is low enough. The follow-up will take place 5 – 9 days after your last departure from the research facility.

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

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 kunt tijdens het onderzoek last krijgen van bijwerkingen. 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 geneesmiddelenonderzoek, moet je een paar keer per dag iets doen voor het onderzoek, zoals een test of gezondheidscheck. Maar je hebt ook veel tijd voor jezelf! In het onderzoekscentrum vind je van alles om die tijd mee in te vullen. Er zijn bijvoorbeeld computers, Playstations, tv’s met Netflix, maar ook een tafeltennistafel, pooltafel en een dartbord. En natuurlijk is er wifi, dus neem gerust je eigen laptop of tablet mee. Sommige deelnemers gaan voor hun werk of studie aan de slag. Maar je kunt natuurlijk ook een paar dagen lekker ontspannen.

Hoeveel geld je krijgt voor jouw deelname aan een geneesmiddelenonderzoek, wordt bepaald door de duur van het onderzoek. Hoe langer het onderzoek duurt, hoe hoger de vergoeding. Maar er zijn meer factoren die de hoogte van de vergoeding bepalen, zoals speciale medische handelingen.

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