Biperiden challenge study
- Conditions
- Healthy volunteers, challenge model, biperiden, Alzheimer's disease
- Registration Number
- NL-OMON26607
- Lead Sponsor
- Centre for Human Drug Research
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 12
1.Elderly male or female subjects aged between 65 and 80 (inclusive) years old;
2.Healthy subjects as defined by the absence of evidence of any clinically relevant active or chronic disease following detailed medical and surgical history review and a complete physical examination including vital signs, 12-lead ECG, haematology, blood chemistry, and urinalysis;
1.Clinically relevant history of abnormal physical or mental health interfering with the study as determined from the medical history review and the physical examinations obtained during the screening visit and/or at the start of the first study day for each period as judged by the investigator (including (but not limited to), neurological, psychiatric, endocrine, cardiovascular (including recent myocardial infarction), respiratory, gastrointestinal, hepatic, renal disorder or presence of narrow-angle glaucoma).
2.History or clinical evidence of any disease and/or existence of any surgical or medical condition which might interfere with the absorption, distribution, metabolism or excretion of the study drugs.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Saccadic eye movement<br /><br>Smooth pursuit<br /><br>Pupillometry<br /><br>Body Sway<br /><br>N-Back task<br /><br>Adaptive tracking test<br /><br>Visual analogue scales (VAS) for alertness, mood, calmness and nausea<br /><br>Tapping test<br /><br>Visual verbal learning test (VVLT)<br /><br>EEG (resting state, ERP: MMN)<br /><br>Pharmacokinetics
- Secondary Outcome Measures
Name Time Method