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CHIEF PD (CHolinesterase Inhibitor to prEvent Falls in Parkinson's Disease) (CHIEF PD)

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ClinicalTrials.gov Identifier: NCT04226248
Recruitment Status : Recruiting
First Posted : January 13, 2020
Last Update Posted : April 19, 2021
Sponsor:
Collaborator:
Royal United Hospitals Bath NHS Foundation Trust
Information provided by (Responsible Party):
University of Bristol

Brief Summary:

Parkinson's disease is a common condition particularly affecting older people. Falls are a very frequent complication of the disease affecting 60% of people with Parkinson's every year. As the population ages, the number of people living with Parkinson's disease and the occurrence of complications will increase. The loss of the chemical dopamine in the brain causes walking in Parkinson's to become slower, unsteady and irregular. People with the condition are therefore at a very high risk of falling. To some extent, people can compensate for these changes by paying more attention to their walking. However, Parkinson's also diminishes memory and thinking ability. This decreases people's ability to pay attention to their walking, especially when doing something at the same time.

Cholinesterase inhibitor (ChEis) are drugs that are currently used to treat people with memory problems in Parkinson's. The effect of these drugs on falls in Parkinson's has been tested to show that treatment has the potential to almost halve the number of falls.

This trial aims to definitively determine whether cholinesterase inhibitors (ChEi), can prevent falls in Parkinson's and whether this treatment is cost effective. 600 participants with Parkinson's disease will be enrolled from hospitals throughout the UK. Participants will be randomly assigned to either receive the drug (ChEi) via a patch or receive a placebo (dummy) treatment via a patch.

Neither the researchers nor the participants will know which group they are in. Participants will take the medication for 12 months and record any falls that they experience in diaries. If successful, this treatment in Parkinson's disease, would tackle one of the most disabling complications of the disease and positive findings will provide robust evidence to change clinical practice.


Condition or disease Intervention/treatment Phase
Parkinson Disease Drug: Rivastigmine Transdermal System Other: Placebo Transdermal System Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: A Phase III Randomised Controlled Trial of Rivastigmine versus Placebo
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Double blind
Primary Purpose: Prevention
Official Title: CHolinesterase Inhibitor to prEvent Falls in Parkinson's Disease: A Phase 3 Randomised, Double-blind Placebo-controlled Trial of Rivastigmine to Prevent Falls in Parkinson's Disease.
Actual Study Start Date : January 2, 2020
Estimated Primary Completion Date : November 12, 2021
Estimated Study Completion Date : November 12, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Active (Rivastigmine)
Rivastigmine Transdermal Patches
Drug: Rivastigmine Transdermal System
Rivastigmine Trandermal Patches applied once a day for up to 12 months

Placebo Comparator: Placebo
Placebo Matched Transdermal Patches
Other: Placebo Transdermal System
Placebo Trandermal Patches applied once a day for up to 12 months




Primary Outcome Measures :
  1. Fall rate [ Time Frame: 12 months from the day the IMP is commenced ]
    Fall rate measured using monthly diaries and telephone calls prospectively


Secondary Outcome Measures :
  1. Parkinson's Disease (PD) [ Time Frame: 12 months ]
    MDS-UPDRS total score in the practically defined 'ON' state and each individual subscale (1-4)

  2. Freezing of gait [ Time Frame: 12 months ]
    New Freezing of Gait Questionnaire (NFOGQ)

  3. Frailty [ Time Frame: 12 months ]
    Frailty assessed by the SHARE-FI

  4. Physical performance [ Time Frame: 12 months ]
    Measured by the Short physical performance battery (SPPB)

  5. Freezing of Gait Assessment [ Time Frame: 12 months ]
    Gait speed measured with Freezing of Gait (turn test)

  6. Gait Assessment [ Time Frame: 12 months ]
    Gait speed measured with and without dual task

  7. Cognition [ Time Frame: 12 months ]
    Montreal Cognitive Assessment (MoCA)

  8. Depression [ Time Frame: 12 months ]
    Geriatric Depression Scale (GDS)

  9. Fear of falling [ Time Frame: 12 months ]
    Iconographical Fall Efficacy Scale (ICON-FES)

  10. Dysphagia [ Time Frame: 12 months ]
    Swallowing Disturbance Questionnaire (SDQ)

  11. Participant health related quality of life [ Time Frame: 0,1,3,6 9 and 12 months ]
    EuroQoL 5D-5L health status questionnaire (EQ-5D-5L)

  12. Capability of older people [ Time Frame: 12 months ]
    ICEpop CAPability measure for Older people (ICECAP-O)

  13. Mortality (all cause and PD-related) [ Time Frame: 12 months ]
    Office of National Statistics (ONS) data

  14. Cost effectiveness by NHS resource use [ Time Frame: 12 months ]
    NHS Hospital Episode Statistics (HES) data

  15. Apathy [ Time Frame: 12 months ]
    Starkstein Apathy Scale



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of idiopathic Parkinson's disease.
  • Modified Hoehn and Yahr stage 1-4 disease as determined at baseline visit.
  • Have experienced a fall in the previous year.
  • Able to walk ≥10m without aids or assistance.
  • 18+ years of age.

Exclusion Criteria:

  • Previous ChEi use in 12 months prior to enrolment.
  • Hypersensitivity to rivastigmine
  • Dementia diagnosed according to MDS criteria (6).
  • Inability to attend or comply with treatment or follow-up scheduling.
  • Non-English-speaking patients (cognitive tests performed in English).
  • Falling ≥4x per day.
  • Unwillingness to use an acceptable method of contraception for the duration of the trial if they are of childbearing potential.
  • Pregnancy and/or breastfeeding

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04226248


Contacts
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Contact: Sandra Neumann, PhD 04401174283111 ext 83111 chief-pd@bristol.ac.uk
Contact: Alison Bamford 004401172483113 ext 83113 chief-pd@bristol.ac.uk

Locations
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United Kingdom
Barking, Havering and Redbridge University Hospitals NHS trust Recruiting
Romford, Accepted, United Kingdom, BS8 1NU
Contact: Lyn Liddiard    01174283113    chief-pd@bristol.ac.uk   
Royal United Hospitals Bath NHS Foundation Trust Recruiting
Bath, Somerset, United Kingdom, BA1 3NG
Contact: Ruth Hamlin    01225 825797    chief-pd@bristol.ac.uk   
Contact: Veronica Lyell         
Imperial College Healthcare NHS Trust Recruiting
London, United Kingdom
Contact: Raquel Lopes       chief-pd@bristol.ac.uk   
Yeovil District Hospital Recruiting
Yeovil, United Kingdom
Contact: Alison Lewis    01935384854    chief-pd@bristol.ac.uk   
Sponsors and Collaborators
University of Bristol
Royal United Hospitals Bath NHS Foundation Trust
Investigators
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Principal Investigator: Emily Henderson, PhD University of Bristol
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Responsible Party: University of Bristol
ClinicalTrials.gov Identifier: NCT04226248    
Other Study ID Numbers: Study 2018-2030
First Posted: January 13, 2020    Key Record Dates
Last Update Posted: April 19, 2021
Last Verified: April 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Bristol:
Parkinson Disease
Parkinson
Rivastigmine
Falls
Cholinesterase Inhibitors
Phase III
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Rivastigmine
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuroprotective Agents
Protective Agents