The primary objective is to examine whether a memory impairment as a result of biperiden treatment (cholinergic M1 antagonist) can be reversed by rivastigmine (a cholinesterase inhibitor). Secondary, we will assess the effects of biperiden and…
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Source
Brief title
Condition
- Other condition
Synonym
Health condition
geen aandoening
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main endpoint is the behavioural score on the verbal learning task (VLT),
the continuous recognition memory task (CRMT), and the spatial memory task
(SMT). Secondary, the event-related potentials during those tasks will be
analysed.
Secondary outcome
Another important parameter is the change in behavioural and brain response to
the choice reaction time task, since this measures a possible sedative effect
of the two drugs.
Background summary
Research on the neurobiological foundations of memory has shown that the
neurotransmitter acetylcholine plays the most important role in memory
processing. Furthermore, the cognitive enhancers used in Alzheimer*s disease
contain cholinergic substances. So far, little research was performed to
unravel in which way cognitive enhancers such as rivastigmine can improve
memory in healthy participants with biperiden-induced cholinergic deficit.
However, this may provide valuable information as to how the cholinergic system
affects memory processing. In this study, we will clarify this issue.
Study objective
The primary objective is to examine whether a memory impairment as a result of
biperiden treatment (cholinergic M1 antagonist) can be reversed by rivastigmine
(a cholinesterase inhibitor). Secondary, we will assess the effects of
biperiden and rivastigmine on electrophysiological correlates of memory.
Study design
The study will be conducted according to a double-blind, placebo-controlled,
4-way cross-over design.
Intervention
Participants will be treated with biperiden, rivastigmine, a combination, or a
placebo. All treatments will be taken orally. The treatment order will be
established by counterbalancing.
Study burden and risks
The time investment for the participants will be around 15 hours in total,
which is comprised of 1) medical assessment by questionnaire and medical
checkup (around 1 hour), 2) training session in which the tasks will be
practised (around 2 hours), and 3) four test sessions of around 3 hours, which
include 1 hour waiting. The day before a recording, the participants are not
allowed to drink any alcohol.
Universiteitssingel 40
6229 ER Maastricht
Nederland
Universiteitssingel 40
6229 ER Maastricht
Nederland
Listed location countries
Age
Inclusion criteria
Male or female, between 18 and 25 years of age, healthy (absence of exclusion criteria), normal static binocular activity, body mass index between 18.5 and 30, willingness to sign an informed consent.
Exclusion criteria
history of cardiac, hepatic, renal, pulmonary, neurological, gastrointestinal, haematological or psychiatric illness, are excessive drinking (>20 glasses of alcohol containing beverages a week), pregnancy or lactation, use of medication other than oral contraceptives, use of recreational drugs from 2 weeks before until the end of the experiment, and any sensory or motor deficits which could reasonably be expected to affect test performance. Those volunteers who have a first-degree relative with a psychiatric disorder or a history of a psychiatric disorder will also be excluded.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
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In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2007-004972-37-NL |
| CCMO | NL19605.068.07 |