Cognitive impairment dementia
Conditions
Interventions
3 study treatments:
IV biperiden Lactate (5mg/mL) 2.6 mg over 60 min (corresponds to biperiden base
2.0 mg)
IV biperiden Lactate (5mg/mL) 1.3 mg over 60 min (corresponds to biperiden base
1.0 mg)
Sponsors
Centre for Human Drug Research
Eligibility
Age
65 Years to 99 Years
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Characterization of the CNS PD profile of IV administered biperiden Neurocart test battery: a. Saccadic eye movements b. Smooth pursuit eye movements c. Pupillometry d. Body sway e. Adaptive tracking f. Visual Analog Scales (VAS) according to Bond and Lader g. N-Back task h. VAS Nausea Cogstate cognitive battery a. Groton maze learning test b. Detection test c. Identification test d. One card learning test e. Digital symbol substitution test qEEG a. power spectra (resting eyes closed, eyes open condition) 2. Characterization of the pharmacokinetic profile of IV administered biperiden Plasma parameters derived by non-compartmental analysis: Cmax, AUC0-inf, AUC0-last, CL, *z, t*, tmax, Vss, Vz, CL 3. To confirm the plasma concentration-effect relationship of biperiden using PK-PD modeling. a. Biperiden PK b. Neurocart test battery: adaptive tracking | — |
Secondary
| Measure | Time frame |
|---|---|
| * Treatment-emergent (serious) adverse events ((S)AEs) throughout the study at every study visit * Concomitant medication throughout the study at every study visit * Vital signs (Pulse Rate (bpm), Systolic blood pressure (mmHg), Diastolic blood pressure (mmHg)) as per assessment schedule * Clinical laboratory tests (Hematology, blood chemistry and urinalysis) as per assessment schedule * ECG parameters (Heart Rate (HR) (bpm), PR, QRS, QT, QTcB, QTcF) as per assessment schedule | — |
Countries
Netherlands
Outcome results
None listed