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

Parkinson Disease Clinical Trial

— EASE-PIGD  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03011476
• Other study ID #: 2016-08-030-003
• Status: Recruiting
• Phase: Phase 4
• First received: December 27, 2016
• Last updated: March 5, 2018
• Start date: April 11, 2017
• Est. completion date: December 30, 2018

Study information

• Verified date: March 2018
• Source: Kyung Hee University Hospital
• Contact: Tae-Beom Ahn, MD, PhD
• Phone: 82-2-958-8499
• Email: taebeom.ahn[@]khu.ac.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 30, 2018
• Est. primary completion date: October 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Kyung Hee Universtiy Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Kyung Hee University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (6)

Bohnen NI, Frey KA, Studenski S, Kotagal V, Koeppe RA, Scott PJ, Albin RL, Müller 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. — View Citation

Bohnen NI, Müller 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. — View 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 M — View 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 — View 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. — View 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 Parkin — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Positron emission tomography using 18F-flurodeoxyglucose		Metabolic change from Baseline at 12 weeks
Secondary	Montreal Cognitive Assessment		Baseline assessment/ Follow-up assessment at 12th week
Secondary	Unified Parkinson disease rating scale (UPDRS)		Baseline assessment/ Follow-up assessment at 4th, 8th and 12th week
Secondary	Time-Up and Go		Baseline assessment/ Follow-up assessment at 4th, 8th and 12th week
Secondary	Gait analysis	Composite measures of gait and balance	Baseline assessment/ Follow-up assessment at 4th, 8th and 12th week