<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03011476</url>
  </required_header>
  <id_info>
    <org_study_id>2016-08-030-003</org_study_id>
    <nct_id>NCT03011476</nct_id>
  </id_info>
  <brief_title>Effect of Acetylcholinesterase Inhibitors on the Gait of the Patients With Parkinson Disease</brief_title>
  <acronym>EASE-PIGD</acronym>
  <official_title>Effect of Acetylcholinesterase Inhibitors on the Gait of the Patients With Parkinson Disease Characterized by Postural Instability and Gait Disturbance</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kyung Hee University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Kyung Hee University Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Cholinergic deficiency in the brain can be related to gait and balance problems in Parkinson&#xD;
      disease (PD). Recent clinical trials suggested a beneficial role of acetylcholinesterase&#xD;
      inhibitors (AchEI) on gait in PD. In this study, the investigators are planning to study the&#xD;
      influence of AchEI on a brain network for gait and balance in PD. As gait problem is&#xD;
      prominent in postural instability and gait disturbance (PIGD) subtype, this study will focus&#xD;
      on the patients with PIGD phenotype.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PD patients with PIGD subtype will be included.&#xD;
&#xD;
        1. Assessment:&#xD;
&#xD;
             -  Overall features of PD are assessed by Unified Parkinson Disease Rating Scale&#xD;
                (UPDRS). Non-motor features including cognition will be assessed by standard&#xD;
                scales. Gait and balance will be assessed by gait analysis system, which measures&#xD;
                physiological parameters of gait such as velocity, variability and center of&#xD;
                pressure. Positron emission tomography using 18F-fluorodeoxyglucose (FDG PET) will&#xD;
                be done to brain activities related to gait and balance.&#xD;
&#xD;
             -  Clinical evaluation will be done at the baseline, 4th, 8th and 12th week&#xD;
&#xD;
             -  Gait analysis and FDG PET will be done at the baseline and 12th week&#xD;
&#xD;
        2. Drug dosage&#xD;
&#xD;
             -  For the first 4 weeks, 5 mg/day&#xD;
&#xD;
             -  Then, 10 mg/day for 8 weeks&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">April 11, 2017</start_date>
  <completion_date type="Anticipated">December 30, 2018</completion_date>
  <primary_completion_date type="Anticipated">October 30, 2018</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Positron emission tomography using 18F-flurodeoxyglucose</measure>
    <time_frame>Metabolic change from Baseline at 12 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Montreal Cognitive Assessment</measure>
    <time_frame>Baseline assessment/ Follow-up assessment at 12th week</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Unified Parkinson disease rating scale (UPDRS)</measure>
    <time_frame>Baseline assessment/ Follow-up assessment at 4th, 8th and 12th week</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time-Up and Go</measure>
    <time_frame>Baseline assessment/ Follow-up assessment at 4th, 8th and 12th week</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Gait analysis</measure>
    <time_frame>Baseline assessment/ Follow-up assessment at 4th, 8th and 12th week</time_frame>
    <description>Composite measures of gait and balance</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Parkinson Disease</condition>
  <arm_group>
    <arm_group_label>Donepezil</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>dosage: 5mg, 10mg frequency: once a day duration: 12 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebos</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>dosage: 5mg, 10mg frequency: once a day duration: 12 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Donepezil</intervention_name>
    <description>Start with 5 mg/day for 4 weeks&#xD;
Increased to 10 mg/day for 8 weeks</description>
    <arm_group_label>Donepezil</arm_group_label>
    <other_name>Aridone</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebos</intervention_name>
    <description>Start with 5 mg/day for 4 weeks&#xD;
Increased to 10 mg/day for 8 weeks</description>
    <arm_group_label>Placebos</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Parkinson disease diagnosed by United Kingdom Parkinson's disease Society Brain Bank&#xD;
             Criteria&#xD;
&#xD;
          -  Postural instability and gait disturbance phenotype&#xD;
&#xD;
          -  Hoehn and Yahr stage ≤ 3&#xD;
&#xD;
          -  Mini-Mental status examination ≥ 24&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Significant motor complication affecting daily activities&#xD;
&#xD;
          -  Drugs related to acetylcholine metabolism&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Tae-Beom Ahn, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Kyung Hee University Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Tae-Beom Ahn, MD, PhD</last_name>
    <phone>82-2-958-8499</phone>
    <email>taebeom.ahn@khu.ac.kr</email>
  </overall_contact>
  <location>
    <facility>
      <name>Kyung Hee Universtiy Hospital</name>
      <address>
        <city>Seoul</city>
        <zip>02447</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Su Jin Hahn, BA</last_name>
      <phone>82-2-958-9579</phone>
      <email>khcri@khmc.or.kr</email>
    </contact>
    <contact_backup>
      <last_name>Kyung Wha Hahn, BA</last_name>
      <phone>82-2-958-9566</phone>
      <email>yynam@khmc.or.kr</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <results_reference>
    <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.</citation>
    <PMID>26795874</PMID>
  </results_reference>
  <results_reference>
    <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.</citation>
    <PMID>24299497</PMID>
  </results_reference>
  <results_reference>
    <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.</citation>
    <PMID>24078735</PMID>
  </results_reference>
  <results_reference>
    <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.</citation>
    <PMID>19917989</PMID>
  </results_reference>
  <results_reference>
    <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.</citation>
    <PMID>25079803</PMID>
  </results_reference>
  <results_reference>
    <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.</citation>
    <PMID>23408503</PMID>
  </results_reference>
  <verification_date>March 2018</verification_date>
  <study_first_submitted>December 27, 2016</study_first_submitted>
  <study_first_submitted_qc>January 3, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 5, 2017</study_first_posted>
  <last_update_submitted>March 5, 2018</last_update_submitted>
  <last_update_submitted_qc>March 5, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">March 7, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Kyung Hee University Hospital</investigator_affiliation>
    <investigator_full_name>Tae-Beom Ahn</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Parkinson Disease</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Donepezil</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03011476
org study id: 2016-08-030-003
nct id: NCT03011476
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Positron emission tomography using 18F-flurodeoxyglucose
time frame: Metabolic change from Baseline at 12 weeks
measure: Montreal Cognitive Assessment
time frame: Baseline assessment/ Follow-up assessment at 12th week
measure: Unified Parkinson disease rating scale (UPDRS)
time frame: Baseline assessment/ Follow-up assessment at 4th, 8th and 12th week
measure: Time-Up and Go
time frame: Baseline assessment/ Follow-up assessment at 4th, 8th and 12th week
measure: Gait analysis
time frame: Baseline assessment/ Follow-up assessment at 4th, 8th and 12th week
description: Composite measures of gait and balance
arm group label: Donepezil
arm group type: Active Comparator
description: dosage: 5mg, 10mg frequency: once a day duration: 12 weeks
arm group label: Placebos
arm group type: Placebo Comparator
description: dosage: 5mg, 10mg frequency: once a day duration: 12 weeks
intervention type: Drug
intervention name: Donepezil
description: Start with 5 mg/day for 4 weeks
Increased to 10 mg/day for 8 weeks
arm group label: Donepezil
other name: Aridone
intervention type: Drug
intervention name: Placebos
description: Start with 5 mg/day for 4 weeks
Increased to 10 mg/day for 8 weeks
arm group label: Placebos
criteria: 
gender: All
minimum age: 40 Years
maximum age: 75 Years
healthy volunteers: No
last name: Tae-Beom Ahn, MD, PhD
role: Principal Investigator
affiliation: Kyung Hee University Hospital
last name: Tae-Beom Ahn, MD, PhD
phone: 82-2-958-8499
email: taebeom.ahn@khu.ac.kr
facility: 
status: Recruiting
contact: 
contact backup: 
country: Korea, Republic of
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.
PMID: 26795874
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.
PMID: 24299497
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.
PMID: 24078735
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.
PMID: 19917989
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.
PMID: 25079803
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.
PMID: 23408503
responsible party type: Principal Investigator
investigator affiliation: Kyung Hee University Hospital
investigator full name: Tae-Beom Ahn
investigator title: Professor
mesh term: Parkinson Disease
mesh term: Donepezil
sharing ipd: No