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EASE-PIGD: Effect of Acetylcholinesterase Inhibitors on the Gait of the Patients With Parkinson Disease

Sponsor
Kyung Hee University Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT03011476
Collaborator
(none)
20
Enrollment
1
Location
2
Arms
20.6
Anticipated Duration (Months)
1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

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

  1. Drug dosage

  • For the first 4 weeks, 5 mg/day

  • Then, 10 mg/day for 8 weeks

Study Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Effect of Acetylcholinesterase Inhibitors on the Gait of the Patients With Parkinson Disease Characterized by Postural Instability and Gait Disturbance
Actual Study Start Date :
Apr 11, 2017
Anticipated Primary Completion Date :
Oct 30, 2018
Anticipated Study Completion Date :
Dec 30, 2018

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Donepezil

dosage: 5mg, 10mg frequency: once a day duration: 12 weeks

Drug: Donepezil
Start with 5 mg/day for 4 weeks Increased to 10 mg/day for 8 weeks
Other Names:
  • Aridone

    		•
    Placebo Comparator: Placebos

    dosage: 5mg, 10mg frequency: once a day duration: 12 weeks

    Drug: Placebos
    Start with 5 mg/day for 4 weeks Increased to 10 mg/day for 8 weeks

    Outcome Measures

    Primary Outcome Measures

    1. Positron emission tomography using 18F-flurodeoxyglucose [Metabolic change from Baseline at 12 weeks]

    Secondary Outcome Measures

    1. Montreal Cognitive Assessment [Baseline assessment/ Follow-up assessment at 12th week]

    2. Unified Parkinson disease rating scale (UPDRS) [Baseline assessment/ Follow-up assessment at 4th, 8th and 12th week]

    3. Time-Up and Go [Baseline assessment/ Follow-up assessment at 4th, 8th and 12th week]

    4. Gait analysis [Baseline assessment/ Follow-up assessment at 4th, 8th and 12th week]

      Composite measures of gait and balance

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    40 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Kyung Hee Universtiy Hospital Seoul Korea, Republic of 02447

    Sponsors and Collaborators

    • Kyung Hee University Hospital

    Investigators

    • Principal Investigator: Tae-Beom Ahn, MD, PhD, Kyung Hee University Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Tae-Beom Ahn, Professor, Kyung Hee University Hospital
    ClinicalTrials.gov Identifier:
    NCT03011476
    Other Study ID Numbers:
    • 2016-08-030-003
    First Posted:
    Jan 5, 2017
    Last Update Posted:
    Mar 7, 2018
    Last Verified:
    Mar 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Parkinson Disease
    Donepezil

    Study Results

    No Results Posted as of Mar 7, 2018