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Effects of rivastigmine on biperiden-induced memory impairment in healthy adults: an EEG study.


- candidate number2833
- NTR NumberNTR1103
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR23-okt-2007
- Secondary IDsgrant nr. 451-07-011 VENI
- Public TitleEffects of rivastigmine on biperiden-induced memory impairment in healthy adults: an EEG study.
- Scientific TitleEffects of rivastigmine on biperiden-induced memory impairment in healthy adults: an EEG study.
- ACRONYMRivastigmine and memory
- hypothesisRivastigmine can reverse a memory impairment that is induced by biperiden, which will be seen both behaviorally and in the EEG.
- Healt Condition(s) or Problem(s) studiedlong-term memory
- Inclusion criteria1. Male or female;
2. 18 to 35 years of age;
3. healthy (i.e. absence of all exclusion criteria);
4. body mass index between 18.5 and 30;
5. willingness to sign an informed consent.
- Exclusion criteria1. History of cardiac, hepatic, renal, pulmonary, neurological, gastrointestinal, haematological, or psychiatric ilness;
2. excessive drinking (> 20 glasses of alcohol containing beverages a week);
3. pregnancy or lactation;
4. use of medication other than oral contraceptives;
5. use of recreational drugs from 2 weeks before the experiment until the end of the study;
6. any sensory or motor deficits which could reasonably be expected to affect test performance;
7. having a first-degree relative with a psychiatric disorder.
- mec approval receivedno
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupCrossover
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-dec-2007
- planned closingdate1-mei-2009
- Target number of participants20
- InterventionsParticipants will participate on 4 separate test days and will be administered either rivastigmine, biperiden, a combination, or a placebo. The order of treatment will be counterbalanced.
- Primary outcomeThe primary endpoint is the behavioral score on a set of memory paradigms, namely a verbal learning task, a picture memory task, and a spatial memory task. Furthermore, the brain activity (EEG and event-related potentials) will be recorded during those tasks.
- Secondary outcomeThe behavioral response and brain activity during a choice reaction time task is recorded in order to find out whether the medication also has sedative effects.
- TimepointsN/A
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES Anke Sambeth
- CONTACT for SCIENTIFIC QUERIES Anke Sambeth
- Sponsor/Initiator University Maastricht, Faculty of Psychology
- Funding
(Source(s) of Monetary or Material Support)
NWO, VENI
- PublicationsN/A
- Brief summaryN/A
- Main changes (audit trail)
- RECORD23-okt-2007 - 25-mrt-2008


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