Randomized, double-blind, placebo-controlled, 3-way cross-over study to characterize the pharmacodynamics and pharmacokinetics of single-dose intravenously administered biperiden in healthy elderly male and female subjects

Completed

• Conditions: Cognitive impairment; dementia; 10057167; 10039628

• Registration Number: NL-OMON51272
• Lead Sponsor: Centre for Human Drug Research

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 12

Inclusion Criteria

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;
5. Absence of cognitive impairment evident by a score of 28 or higher on the
Mini Mental State Examination (MMSE);

Exclusion Criteria

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 (including myasthenia gravis,
epilepsy and tardive dyskinesia), cardiovascular (including current
hypertension, orthostatic hypotension and recent myocardial infarction),
respiratory, gastrointestinal (including previous ileus or megacolon and past
or current gastro-intestinal stenosis), hepatic, renal, urogenital (including
urinary retention or prostate hypertrophy) disorder or presence of narrow-angle
glaucoma).
2. Current or history of any clinically relevant psychiatric disorder as
classified according to DSM-IV or DSM 5 (e.g. psychotic disorder e.g.
schizophrenia/schizo-affective disorder, bipolar disorder Type I or Type II,
personality disorder, major depressive disorder/persistent depressive disorder,
obsessive-compulsive disorder, panic disorder, anorexia nervosa, bulimia
nervosa, generalized anxiety disorder (GAD), post-traumatic stress disorder
(PTSD), autism spectrum disorder (ASD) sleep disorders and previous delirium).
3. Any disease associated with cognitive impairment
5. History of hypersensitivity to biperiden or to the excipients used in the
biperiden formulation.

Study & Design

• Study Type: Interventional
• Study Design: Not specified