Parkinson DiseasePhase 4EASE-PIGDNCT03011476
Effect of Acetylcholinesterase Inhibitors on the Gait of the Patients With Parkinson Disease
A Phase 4 study testing Donepezil in people with Parkinson Disease, run by Kyung Hee University Hospital at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Donepezil
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteSouth Korea
- Study dates
- 11 Apr 2017to 30 Dec 2018
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Significant motor complication affecting daily activities
- Drugs related to acetylcholine metabolism
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Kyung Hee Universtiy Hospital
Seoul, 02447
Su Jin Hahn, BA, 82-2-958-9579, khcri@khmc.or.kr
Kyung Wha Hahn, BA, 82-2-958-9566, yynam@khmc.or.kr
About this study
Official title: 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.
Read the 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
- Conditions
- Parkinson Disease
- Being tested
- Donepezil, Placebos
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DonepezilDrug
Also called Aridone
- Start with 5 mg/day for 4 weeks
- Increased to 10 mg/day for 8 weeks
PlacebosDrug
- Start with 5 mg/day for 4 weeks
- Increased to 10 mg/day for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Donepezil | Active comparator | dosage: 5mg, 10mg frequency: once a day duration: 12 weeks Receives: Drug: Donepezil |
| Placebos | Placebo comparator | dosage: 5mg, 10mg frequency: once a day duration: 12 weeks Receives: Drug: Placebos |
What is being measured
The primary outcome is the main question the study is designed to answer.
Positron emission tomography using 18F-flurodeoxyglucose
Measured: Metabolic change from Baseline at 12 weeks
Secondary outcomes (4)
Montreal Cognitive Assessment
Measured: Baseline assessment/ Follow-up assessment at 12th week
Unified Parkinson disease rating scale (UPDRS)
Measured: Baseline assessment/ Follow-up assessment at 4th, 8th and 12th week
Time-Up and Go
Measured: Baseline assessment/ Follow-up assessment at 4th, 8th and 12th week
Gait analysis
Composite measures of gait and balance
Measured: Baseline assessment/ Follow-up assessment at 4th, 8th and 12th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2017 (estimated)
- Study start11 Apr 2017
- Primary completion30 Oct 2018 (estimated)
- Study completion30 Dec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kyung Hee University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tae-Beom Ahn, Kyung Hee University Hospital
- Investigators
- Tae-Beom Ahn, MD, PhD, Principal investigator, Kyung Hee University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03011476
- Sponsor's protocol ID
- 2016-08-030-003
- Acronym
- EASE-PIGD
- Status last verified
- Mar 2018
- First submitted
- 27 Dec 2016
- Last updated
- 7 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 26795874Henderson 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.
PubMed 24299497Bohnen 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.
PubMed 24078735Bohnen 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.
PubMed 19917989Montero-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.
PubMed 25079803Stebbins 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.
PubMed 23408503
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Acetylcholinesterase Inhibitors on the Gait of the Patients With Parkinson Disease Characterized by Postural Instability and Gait Disturbance
- ClinicalTrials.gov ID
- NCT03011476
- Acronym / sponsor ID
- EASE-PIGD / 2016-08-030-003
- Conditions
- Parkinson Disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Kyung Hee University HospitalUniversity, hospital or other
- Study start
- 11 Apr 2017 (actual)
- Primary completion
- 30 Oct 2018 (estimated)
- Study completion
- 30 Dec 2018 (estimated)
- First posted
- 5 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Donepezil | Active comparator | Drug: Donepezildosage: 5mg, 10mg frequency: once a day duration: 12 weeks |
| Placebos | Placebo comparator | Drug: Placebosdosage: 5mg, 10mg frequency: once a day duration: 12 weeks |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Significant motor complication affecting daily activities
- Drugs related to acetylcholine metabolism
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DonepezilAlso: Aridone1. Start with 5 mg/day for 4 weeks 2. Increased to 10 mg/day for 8 weeks | Drug | Donepezil |
| Placebos1. Start with 5 mg/day for 4 weeks 2. Increased to 10 mg/day for 8 weeks | Drug | Placebos |
Primary outcome
Positron emission tomography using 18F-flurodeoxyglucose
Time frame: Metabolic change from Baseline at 12 weeks
4 secondary outcomes
Montreal Cognitive Assessment
Time frame: 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
Time-Up and Go
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2018.
- Results publication: PubMed 26795874Henderson 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 publication: PubMed 24299497Henderson 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 publication: PubMed 24078735Bohnen 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 publication: PubMed 19917989Bohnen 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 publication: PubMed 25079803Montero-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 publication: PubMed 23408503Stebbins 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tae-Beom Ahn, MD, PhD principal investigator
Kyung Hee University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Donepezil in people with Parkinson Disease, run by Kyung Hee University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tae-Beom Ahn, MD, PhD (82-2-958-8499, taebeom.ahn@khu.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Positron emission tomography using 18F-flurodeoxyglucose (time frame: Metabolic change from Baseline at 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03011476, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2018.