Examining the pharmacokinetic and pharmacodynamic profile of biperide

Conditions: geheugen/ memory

Registration Number: NL-OMON24672

Lead Sponsor: Maastricht University

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 27

Inclusion Criteria

•In the opinion of the investigator, the participant is capable of understanding and complying with protocol requirements.

•The participant has a body mass index of 18.5-30 kg/m2, inclusive, at medical screening.

Exclusion Criteria

•The subject has uncontrolled, clinically significant neurologic, cardiovascular, pulmonary, hepatic, renal, metabolic, gastrointestinal, or endocrine disease or other abnormality which may impact the ability of the subject to participate or potentially confound the study results.

•The volunteer has uncontrolled existing major psychiatric symptoms.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The main endpoints for the cognitive tasks are the behavioral score on the immediate and delayed recall of the VLT. This includes the number of words recalled immediately and after a 20 minute delay.

Secondary Outcome Measures

Name	Time	Method
Secondary, to establish the pharmacokinetic and pharmacodynamics profile of biperiden the primary endpoints will be the blood serum values and physiological measures (body temperature, blood pressure, heart rate and pupil size). Furthermore the behavioral outcomes of the n-back and simple and choice reaction tasks will be used for analysis, as well as the scores on the B&L and complaints questionnaire. Next to this, the event-related potentials during the behavioural tasks will be analysed. Another important measure is the brain response to the novelty oddball task, which will give an indication of the role of acetylcholine in novelty processing.