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

NCT03011476 | Unknown Phase 4

• 1 other identifier: 2016-08-030-003
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (1)

• Positron emission tomography using 18F-flurodeoxyglucose

  Metabolic change from Baseline at 12 weeks

Secondary Outcomes (4)

• Montreal Cognitive Assessment

  Baseline assessment/ Follow-up assessment at 12th week

• Unified Parkinson disease rating scale (UPDRS)

  Baseline assessment/ Follow-up assessment at 4th, 8th and 12th week

• Time-Up and Go

  Baseline assessment/ Follow-up assessment at 4th, 8th and 12th week

• Gait analysis

  Baseline assessment/ Follow-up assessment at 4th, 8th and 12th week

Study Arms (2)

Donepezil

ACTIVE COMPARATOR

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

Drug: Donepezil

Placebos

PLACEBO COMPARATOR

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

Drug: Placebos

Interventions

Donepezil DRUG

1. Start with 5 mg/day for 4 weeks 2. Increased to 10 mg/day for 8 weeks

Also known as: Aridone

Donepezil

Placebos DRUG

1. Start with 5 mg/day for 4 weeks 2. Increased to 10 mg/day for 8 weeks

Placebos

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Significant motor complication affecting daily activities
• Drugs related to acetylcholine metabolism

Sponsors & Collaborators

• Kyung Hee University Hospital: lead

Study Sites (1)

Kyung Hee Universtiy Hospital

Seoul, 02447, South Korea

RECRUITING

Related Publications (6)

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

MeSH Terms

Conditions

Parkinson Disease

Interventions

Donepezil

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Indans; Indenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Polycyclic Compounds

Study Officials

• Tae-Beom Ahn, MD, PhD

  Kyung Hee University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tae-Beom Ahn, MD, PhD

CONTACT

82-2-958-8499; taebeom.ahn@khu.ac.kr

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 27, 2016
• First Posted: January 5, 2017
• Study Start: April 11, 2017
• Primary Completion: October 30, 2018
• Study Completion: December 30, 2018
• Last Updated: March 7, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)