Biomarker . Methodology risk of falling walking (adapt)ability
Conditions
Interventions
Suvorexant 10 mg
Zolpidem 5 mg
Placebo
Sponsors
Centre for Human Drug Research
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Male and female subjects aged between 65 years and 80 years (inclusive) at screening. 2. Body mass index (BMI) within the range of 18 to 30 kg/m2 (inclusive) at screening. 3. Systolic blood pressure 100-160 mmHg, diastolic blood pressure 50-95 mmHg, and pulse rate 45-100 bpm (inclusive), measured on either arm, after 5 min in the supine position at screening. 4. Estimated creatinine clearance (using the Cockcroft &Gault formula) *60 mL/min to allow for some reduced renal function in the elderly. 5. Subject has a regular sleep pattern (bedtime between 22:00 and 00:30 and sleep for at least 6 h).
Exclusion criteria
Exclusion criteria: 1. Hypersensitivity to benzodiazepines and/ or meeting contraindication criteria for zolpidem: myasthenia gravis, sleep apnea syndrome, liver failure, respiratory depression. 2. Hypersensitivity to orexin antagonist and/ or meeting contraindication criteria for suvorexant: narcolepsy. 3. Regular use of sedative/hypnotic drugs. 4. Regular use of walking aids. 5. Recurrent fallers defined as > 3 falls per year. 6. Neurological diseases and/or orthopedic problems interfering with gait function 7. Mini Mental State Examination score
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacodynamic endpoints The Interactive Walkway takes approximately 15 minutes and includes the following tests: * 8-meter walking test. Walking at a self-selected walking speed. The outcome measures are walking speed (cm/s), step length (cm), step width (cm), cadence (steps/min), and step time (s). The test has a duration of approximately 1-2 minutes. * Obstacle avoidance. Avoiding suddenly appearing obstacles. The outcome measures are obstacle-avoidance margins (cm), success rate (%), and (normalized) walking speed (%). The test has a duration of approximately 4-5 minutes. * Goal-directed stepping. Stepping as accurately as possible onto the shoe-size-matched steppingstones placed in an irregular pattern. The outcome measures are stepping accuracy (cm) and (normalized) walking speed (%). The test has a duration of approximately 1-2 minutes. * Tandem walking. Walking on a line. The outcome measures are success rate (%), (normalized) walking speed (%), and mediolateral sway (cm). The test has a duration of approximately 1-2 minutes. * Timed Up-and-Go test. Rising from a standard armchair, walking to a line on the floor 3 meters away, turning, returning, and sitting down again. The outcome measures is time (s). The test has a duration of approximately 3-4 minutes. The NeuroCart for this study includes the following tests: * Body Sway. This test assesses postural stability. The outcome measure is sway (mm). The test has a duration of approximately 2 minutes. * Adaptive Tracker. This test assesses pursuit-tracking. The outcome measure is success rate (%) The test has a duration of approximately 3 minutes. The Withings Steel HR smartwatch includes the following tests: * Step count * Heart rate * Sleep pattern (time it takes to fall asleep, sleep duration, sleep cycles and sleep interruptions) * Physical activity duration Pharmacokinetic endpoints PK parameters of suvorexant and zolpidem by non-compartmental analysis of the plasma con | — |
Countries
Netherlands
Outcome results
None listed