PRA-19442X

Memory loss in the elderly

Study of a combination of registered medication that could be used for the treatment of memory loss in the elderly

Particulars

  • You are between 65 and 85 years old
  • You do not smoke
  • Your Body Mass Index (BMI) is between 19 and 35 kg/m2.
  • You have recently experienced memory loss or confusion that is occurring more often or worsening.
  • As a male you are only allowed to participate in this study if:
    • you use a condom and your fertile female partner uses an effective form of contraception, or
    • your female partner is sterile or post-menopausal, or
    • you have been sterilized.
  • As a female you are only allowed to participate in this study if:
    • you have been surgically sterilized at least 6 months before screening;
    • or you have been postmenopausal for at least a year (without menstrual periods).
  • You have not participated in any other drug study within 60 days preceding the first administration of the study compound.
  • To determine if you are eligible to participate in this study, you will undergo a medical screening.
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Compensation

For Part A you will receive a gross compensation of €1212 for full participation in this group of this study.

For groups B1 to B15 you will receive a gross compensation of €462 for full participation in one of these groups of this study.

Travelling 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 return, irrespective of the method of transportation.

Period of stay and research

Part A

The study of this group consists of 4 periods. During period 1 and 3 you will stay for 2 days (1 night) in the research center in Groningen. During period 2 and 4 your will stay for 3 days (2 nights) in the research center in Groningen. After period 1 and 3 you need to take home medication for 5 days at home. Finally there will be a follow-up visit in the research center.

Part B

For groups B1 to B15, the study consists of 2 periods. During each period you will stay for 2 days (1 night) in the research center in Groningen. After this 1st period, you will need to take home medication for 5 days at home. Finally there will be a follow-up visit in the research center.

In part A and B during the days with home medication, you will receive a phonecall twice daily to help you remember to take your study medication.

Please note: You must be available for all dates for the group of choice to be able to participate in this study. These are the currently planned dates; however, these may be subject to change.

More info

Type of study

Soon a new research study will start at PRA to investigate a combination of registered medication that could be used for the treatment of memory loss in the eldery.

The purpose of this study is to investigate how safe modafinil is and how well it is tolerated when it is administered to alone or in combination with aniracetam to generally healthy elderly volunteers. Modafinil and aniracetam are not new compounds, they are already available on the market in several dosages and formulations. It will also be investigated how quickly and to what extent modafinil is absorbed and eliminated from the body (this is called pharmacokinetics). In addition, the effect of modafinil in combination with aniracetam on cognitive function (all processes involved in the recording and processing of information) will be investigated.

Modafinil has been on the market in Europe and in the US, this compound is used for the treatment of excessive sleepiness in adults with narcolepsy. Aniracetam is a drug that has possible cognition enhancing effects. This study does not aim to improve your health, but is necessary for the further development of this compound. The study will only take place after it has been approved by the Independent Ethics Committee.

Setup and duration of the study

Part A.
The study of this group consists of 4 periods. During period 1 and 3 you will stay for 2 days (1 night) in the research center in Groningen. During period 2 and 4 you will stay for 3 days (2 nights) in our research center in Groningen. After period 1 and 3 you need to take homemedication for 5 days at home. Finally there will be a follow-up visit in the research center.

Both modafinil and aniracetam will be given daily as oral capsules with tap water, after fasting for at least 1½ hours. After dosing you will remain fasted for another 3 hours, after this you will receive lunch. After each period in the research center you need to take home medication for 5 days. Durings these 5 days you will receive twice daily a phone call to help you remember to take your homemedication.

Part B.
The study consist for group B1 till B13 of 2 periods. During each period you will stay for 2 days (1 night) in the research center in Groningen. After this 1st period you need to take homemedication for 5 days at home. Finally there will be a follow-up visit in the research center. Both modafinil and aniracetam will be given daily as oral capsules with tap water, after fasting for at least 1½ hours. After dosing you will remain fasted for another 3 hours, after this you will receive lunch. After the 1st period in the research center you need to take home medication for 5 days, after this the second period in the research center will follow. Durings these 5 homemedication days you will receive twice daily a phone call to help you remember to take your homemedication.

You can find the exact dates of each group on our website. If the dates do change you will be notified as soon as possible. Upon admission to the clinic you must have fasted for at least 4 hours. Before the start of the study you will visit the medical screening centre for a medical screening. Blood samples will be taken regularly during the study.

Risks and medical supervision

All potential drugs can cause adverse events. Both compounds that will be given in this study are registred medications. The most commonly observed side effect of Modafinil (in 10% of patients or more) is headache. During the medical screening you will receive the modafinil package leaflet. Aniracetam is generally well tolerated by patients. The most important observed side effects are headache, nervousness, irritability, insomnia, nausea, and vomiting.

You should be aware that still unknown side effects may occur during the study. You will be under strict medical supervision during the study and at the end of the study you will undergo an extensive medical screening.

Conditions for participation

You are a healthy male or female between 65 and 85 years old. Your Body Mass Index (BMI) is between 19.0 and 35.0 kg/m2 (The BMI reflects the relation between your body weight in kilograms and your height in meters). You have lately experienced memory loss or confusion that occurs more often or worsens. You can only take part in the study if you do not smoke. As a male you are only allowed to participate in this study if you use a condom and your female partner, if she is fertile, uses an effective form of contraception, or your female partner is sterile or post-menopausal, or you are sterilized.

As a female you are only allowed to participate in this study if you are surgically sterilized at least 6 months before screening, or you are postmenopausal for at least 12 months (without menstrual periods) before screening. The study will be executed under standardized conditions. Use of alcohol, regular coffee and tea, cola, power drinks, chocolate (milk), grapefruit (juice) and tobacco products during the study is not allowed. Also before the study and each period there may be restrictions for these products. Use of decaffeinated coffee and (herbal) teas without caffeine (also called theine) is allowed. Before you are allowed to take part in the study, you will be medically screened; this screening will take place within four weeks before the start of the study.

Sign up for one of the following study groups

Group B5

2× 2 days stay

  • 12 Nov 2019 up to and including 13 Nov 2019
  • 18 Nov 2019 up to and including 19 Nov 2019
€ 462,- Select

Group B6

2× 2 days stay

  • 20 Nov 2019 up to and including 21 Nov 2019
  • 26 Nov 2019 up to and including 27 Nov 2019
€ 462,- Select

Group B7

2× 2 days stay

  • 30 Nov 2019 up to and including 1 Dec 2019
  • 6 Dec 2019 up to and including 7 Dec 2019
€ 462,- Select

Group B8

2× 2 days stay

  • 8 Dec 2019 up to and including 9 Dec 2019
  • 14 Dec 2019 up to and including 15 Dec 2019
€ 462,- Select

Group B9

2× 2 days stay

  • 10 Dec 2019 up to and including 11 Dec 2019
  • 16 Dec 2019 up to and including 17 Dec 2019
€ 462,- Select

Group B10

2× 2 days stay

  • 22 Dec 2019 up to and including 23 Dec 2019
  • 28 Dec 2019 up to and including 29 Dec 2019
€ 462,- Select
Show full groups

Group A1

Full

2× 2 days en 3 days stay

  • 30 Sep 2019 up to and including 1 Oct 2019
  • 6 Oct 2019 up to and including 8 Oct 2019
  • 15 Oct 2019 up to and including 16 Oct 2019
€ 1.212,- Select

Group B1

Full

2× 2 days stay

  • 14 Oct 2019 up to and including 15 Oct 2019
  • 20 Oct 2019 up to and including 21 Oct 2019
€ 462,- Select

Group B2

Full

2× 2 days stay

  • 23 Oct 2019 up to and including 24 Oct 2019
  • 29 Oct 2019 up to and including 30 Oct 2019
€ 462,- Select

Group B3

Full

2× 2 days stay

  • 31 Oct 2019 up to and including 1 Nov 2019
  • 6 Nov 2019 up to and including 7 Nov 2019
€ 462,- Select

Group B4

Full

2× 2 days stay

  • 4 Nov 2019 up to and including 5 Nov 2019
  • 10 Nov 2019 up to and including 11 Nov 2019
€ 462,- Select