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

March 5, 2018 updated by: Tae-Beom Ahn, Kyung Hee University Hospital

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 02447
        • Recruiting
        • Kyung Hee Universtiy Hospital
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Donepezil
dosage: 5mg, 10mg frequency: once a day duration: 12 weeks
Drug: Donepezil
  1. Start with 5 mg/day for 4 weeks
  2. 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
  1. Start with 5 mg/day for 4 weeks
  2. Increased to 10 mg/day for 8 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Positron emission tomography using 18F-flurodeoxyglucose
Time Frame: Metabolic change from Baseline at 12 weeks
Metabolic change from Baseline at 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Montreal Cognitive Assessment
Time Frame: Baseline assessment/ Follow-up assessment at 12th week
Baseline assessment/ Follow-up assessment at 12th week
Unified Parkinson disease rating scale (UPDRS)
Time Frame: Baseline assessment/ Follow-up assessment at 4th, 8th and 12th week
Baseline assessment/ Follow-up assessment at 4th, 8th and 12th week
Time-Up and Go
Time Frame: Baseline assessment/ Follow-up assessment at 4th, 8th and 12th week
Baseline assessment/ Follow-up assessment at 4th, 8th and 12th week
Gait analysis
Time Frame: Baseline assessment/ Follow-up assessment at 4th, 8th and 12th week
Composite measures of gait and balance
Baseline assessment/ Follow-up assessment at 4th, 8th and 12th week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kyung Hee University Hospital

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 11, 2017

Primary Completion (Anticipated)

October 30, 2018

Study Completion (Anticipated)

December 30, 2018

Study Registration Dates

First Submitted

December 27, 2016

First Submitted That Met QC Criteria

January 3, 2017

First Posted (Estimate)

January 5, 2017

Study Record Updates

Last Update Posted (Actual)

March 7, 2018

Last Update Submitted That Met QC Criteria

March 5, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016-08-030-003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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