NCT03011476

Effect of Acetylcholinesterase Inhibitors on the Gait of the Patients With Parkinson Disease

Effect of Acetylcholinesterase Inhibitors on the Gait of the Patients With Parkinson Disease Characterized by Postural Instability and Gait Disturbance

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Kyung Hee University Hospital · Academic / Other
• Sex: All
• Age: 40 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Cholinergic deficiency in the brain can be related to gait and balance problems in Parkinson disease (PD). Recent clinical trials suggested a beneficial role of acetylcholinesterase inhibitors (AchEI) on gait in PD. In this study, the investigators are planning to study the influence of AchEI on a brain network for gait and balance in PD. As gait problem is prominent in postural instability and gait disturbance (PIGD) subtype, this study will focus on the patients with PIGD phenotype.

Detailed description

PD patients with PIGD subtype will be included. 1. Assessment: * Overall features of PD are assessed by Unified Parkinson Disease Rating Scale (UPDRS). Non-motor features including cognition will be assessed by standard scales. Gait and balance will be assessed by gait analysis system, which measures physiological parameters of gait such as velocity, variability and center of pressure. Positron emission tomography using 18F-fluorodeoxyglucose (FDG PET) will be done to brain activities related to gait and balance. * Clinical evaluation will be done at the baseline, 4th, 8th and 12th week * Gait analysis and FDG PET will be done at the baseline and 12th week 2. Drug dosage * For the first 4 weeks, 5 mg/day * Then, 10 mg/day for 8 weeks

Conditions

• Parkinson Disease

Interventions

Type	Name	Description
DRUG	Donepezil	1. Start with 5 mg/day for 4 weeks 2. Increased to 10 mg/day for 8 weeks
DRUG	Placebos	1. Start with 5 mg/day for 4 weeks 2. Increased to 10 mg/day for 8 weeks

Timeline

• Start date: 2017-04-11
• Primary completion: 2018-10-30
• Completion: 2018-12-30
• First posted: 2017-01-05
• Last updated: 2018-03-07

Locations

1 site across 1 country: South Korea