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

Primary Purpose

Parkinson Disease

Status
Unknown status
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Donepezil
Placebos
Sponsored by
Kyung Hee University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Kyung Hee Universtiy HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Donepezil

Placebos

Arm Description

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

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

Outcomes

Primary Outcome Measures

Positron emission tomography using 18F-flurodeoxyglucose

Secondary Outcome Measures

Montreal Cognitive Assessment
Unified Parkinson disease rating scale (UPDRS)
Time-Up and Go
Gait analysis
Composite measures of gait and balance

Full Information

First Posted
December 27, 2016
Last Updated
March 5, 2018
Sponsor
Kyung Hee University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03011476
Brief Title
Effect of Acetylcholinesterase Inhibitors on the Gait of the Patients With Parkinson Disease
Acronym
EASE-PIGD
Official Title
Effect of Acetylcholinesterase Inhibitors on the Gait of the Patients With Parkinson Disease Characterized by Postural Instability and Gait Disturbance
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Unknown status
Study Start Date
April 11, 2017 (Actual)
Primary Completion Date
October 30, 2018 (Anticipated)
Study Completion Date
December 30, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kyung Hee University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
Detailed Description
PD patients with PIGD subtype will be included. 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 Drug dosage For the first 4 weeks, 5 mg/day Then, 10 mg/day for 8 weeks

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Donepezil
Arm Type
Active Comparator
Arm Description
dosage: 5mg, 10mg frequency: once a day duration: 12 weeks
Arm Title
Placebos
Arm Type
Placebo Comparator
Arm Description
dosage: 5mg, 10mg frequency: once a day duration: 12 weeks
Intervention Type
Drug
Intervention Name(s)
Donepezil
Other Intervention Name(s)
Aridone
Intervention Description
Start with 5 mg/day for 4 weeks Increased to 10 mg/day for 8 weeks
Intervention Type
Drug
Intervention Name(s)
Placebos
Intervention Description
Start with 5 mg/day for 4 weeks Increased to 10 mg/day for 8 weeks
Primary Outcome Measure Information:
Title
Positron emission tomography using 18F-flurodeoxyglucose
Time Frame
Metabolic change from Baseline at 12 weeks
Secondary Outcome Measure Information:
Title
Montreal Cognitive Assessment
Time Frame
Baseline assessment/ Follow-up assessment at 12th week
Title
Unified Parkinson disease rating scale (UPDRS)
Time Frame
Baseline assessment/ Follow-up assessment at 4th, 8th and 12th week
Title
Time-Up and Go
Time Frame
Baseline assessment/ Follow-up assessment at 4th, 8th and 12th week
Title
Gait analysis
Description
Composite measures of gait and balance
Time Frame
Baseline assessment/ Follow-up assessment at 4th, 8th and 12th week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tae-Beom Ahn, MD, PhD
Phone
82-2-958-8499
Email
taebeom.ahn@khu.ac.kr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tae-Beom Ahn, MD, PhD
Organizational Affiliation
Kyung Hee University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kyung Hee Universtiy Hospital
City
Seoul
ZIP/Postal Code
02447
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Su Jin Hahn, BA
Phone
82-2-958-9579
Email
khcri@khmc.or.kr
First Name & Middle Initial & Last Name & Degree
Kyung Wha Hahn, BA
Phone
82-2-958-9566
Email
yynam@khmc.or.kr

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
26795874
Citation
Henderson EJ, Lord SR, Brodie MA, Gaunt DM, Lawrence AD, Close JC, Whone AL, Ben-Shlomo Y. Rivastigmine for gait stability in patients with Parkinson's disease (ReSPonD): a randomised, double-blind, placebo-controlled, phase 2 trial. Lancet Neurol. 2016 Mar;15(3):249-58. doi: 10.1016/S1474-4422(15)00389-0. Epub 2016 Jan 13.
Results Reference
result
PubMed Identifier
24299497
Citation
Henderson EJ, Lord SR, Close JC, Lawrence AD, Whone A, Ben-Shlomo Y. The ReSPonD trial--rivastigmine to stabilise gait in Parkinson's disease a phase II, randomised, double blind, placebo controlled trial to evaluate the effect of rivastigmine on gait in patients with Parkinson's disease who have fallen. BMC Neurol. 2013 Dec 3;13:188. doi: 10.1186/1471-2377-13-188.
Results Reference
result
PubMed Identifier
24078735
Citation
Bohnen NI, Frey KA, Studenski S, Kotagal V, Koeppe RA, Scott PJ, Albin RL, Muller ML. Gait speed in Parkinson disease correlates with cholinergic degeneration. Neurology. 2013 Oct 29;81(18):1611-6. doi: 10.1212/WNL.0b013e3182a9f558. Epub 2013 Sep 27.
Results Reference
result
PubMed Identifier
19917989
Citation
Bohnen NI, Muller ML, Koeppe RA, Studenski SA, Kilbourn MA, Frey KA, Albin RL. History of falls in Parkinson disease is associated with reduced cholinergic activity. Neurology. 2009 Nov 17;73(20):1670-6. doi: 10.1212/WNL.0b013e3181c1ded6.
Results Reference
result
PubMed Identifier
25079803
Citation
Montero-Odasso M, Muir-Hunter SW, Oteng-Amoako A, Gopaul K, Islam A, Borrie M, Wells J, Speechley M. Donepezil improves gait performance in older adults with mild Alzheimer's disease: a phase II clinical trial. J Alzheimers Dis. 2015;43(1):193-9. doi: 10.3233/JAD-140759.
Results Reference
result
PubMed Identifier
23408503
Citation
Stebbins GT, Goetz CG, Burn DJ, Jankovic J, Khoo TK, Tilley BC. How to identify tremor dominant and postural instability/gait difficulty groups with the movement disorder society unified Parkinson's disease rating scale: comparison with the unified Parkinson's disease rating scale. Mov Disord. 2013 May;28(5):668-70. doi: 10.1002/mds.25383. Epub 2013 Feb 13.
Results Reference
result

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

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