The effects on the body and processing by the body of biperiden injected into the blood in elderly subjects
- Conditions
- Improving the cognitive impairment associated with dementia and other neurocognitive disordersNervous System Diseases
- Registration Number
- ISRCTN91879618
- Lead Sponsor
- Centre for Human Drug Research
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- 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
3. Absence of cognitive impairment evident by a score of 28 or higher on the Mini-Mental State Examination (MMSE)
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.
4. History of severe allergies, or history of an anaphylactic reaction to prescription or non-prescription drugs or food.
5. History of hypersensitivity to biperiden or to the excipients used in the biperiden formulation.
6. Positive test for Hepatitis B surface antigen (HBsAg), Hepatitis C antibody (HCV Ab), or human immunodeficiency virus antibody (HIV Ab) at screening.
7. Positive urine drug screen (UDS), or alcohol breath test at screening and/or upon admission to the Clinical Research Unit (CRU).
8. Presence or history (within 3 months of screening) of alcohol abuse confirmed by medical history, or daily alcohol consumption exceeding 2 standard drinks per day on average for females or exceeding 3 standard drinks per day on average for males (1 standard drink = 10 grams of alcohol), and the inability to refrain from alcohol during the visits until discharge from the CRU (alcohol consumption will be prohibited during study confinement).
9. Use of tobacco and/or nicotine-containing products within 90 days of dosing and throughout the study until follow-up.
10. Excessive caffeine consumption, defined as >800 mg per day from 7 days prior to the first dose of the study drug until 24 hours prior to dosing. Subjects will abstain from caffeine-containing products for 24 hours prior each dosing and whilst in the study unit until discharge from the study unit. At other times throughout the study, subjects should not consume more than 800 mg caffeine per day. Caffeine quantities defined as: one cup of coffee contains 100 mg of caffeine; one cup of tea, or one glass of cola, or potion of chocolate (dark: 100 g, milk 200 g) contains approximately 40 mg of caffeine; one bottle of Red Bull contains approximately 80 mg of caffeine.
11. Any other concurrent disease or condition that could interfere with, or for which the concomitant treatment might interfere with, the conduct of the study, or that would, in the opinion of the Investigator, pose an unaccep
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Sustained attention and visuomotor coordination using adaptive tracking at baseline, 20 minutes, 1h, 2.5 h, 4 h, 7 h and 24 h
- Secondary Outcome Measures
Name Time Method <br> 1. Measuring drug effects, sedation, memory and coordination using the Neurocart test battery at baseline, 20 minutes, 1 h, 2.5 h, 4 h, 7 h and 24 h<br> 2. Measuring memory, attention and psychomotor function using the Cogstate test battery at baseline, 2 h and 3.5 h<br> 3. Measuring the pharmacokinetic profile of biperiden in plasma at baseline, 20 minutes, 1 h, 2 h, 3 h, 5 h, 7 h and 11 h<br> 4. Measuring safety of biperiden using:<br> 4.1. Treatment-emergent (serious) adverse events ([S]AEs) and concomitant medication throughout the study at every study visit<br> 4.2. Vital signs, respiratory rate and ECG at baseline, 1.5 h, 3 h, 6 h and 24 h<br> 4.3. Clinical laboratory tests (Hematology, blood chemistry and urinalysis) at baseline and 24 h<br>