Parkinson Disease
Conditions
Brief 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
Interventions
DRUGDonepezil
1. Start with 5 mg/day for 4 weeks 2. Increased to 10 mg/day for 8 weeks
DRUGPlacebos
1. Start with 5 mg/day for 4 weeks 2. Increased to 10 mg/day for 8 weeks
Sponsors
Kyung Hee University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Parkinson disease diagnosed by United Kingdom Parkinson's disease Society Brain Bank Criteria * Postural instability and gait disturbance phenotype * Hoehn and Yahr stage ≤ 3 * Mini-Mental status examination ≥ 24
Exclusion criteria
* Significant motor complication affecting daily activities * Drugs related to acetylcholine metabolism
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Positron emission tomography using 18F-flurodeoxyglucose | Metabolic change from Baseline at 12 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Montreal Cognitive Assessment | Baseline assessment/ Follow-up assessment at 12th week | — |
| Unified Parkinson disease rating scale (UPDRS) | Baseline assessment/ Follow-up assessment at 4th, 8th and 12th week | — |
| Time-Up and Go | Baseline assessment/ Follow-up assessment at 4th, 8th and 12th week | — |
| Gait analysis | Baseline assessment/ Follow-up assessment at 4th, 8th and 12th week | Composite measures of gait and balance |
Countries
South Korea
Contacts
Primary ContactTae-Beom Ahn, MD, PhD
Outcome results
None listed