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

January 17, 2023 updated by: University of Bristol

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.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

600

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United Kingdom
      • Aberdeen, United Kingdom, AB15 6RE
        • Recruiting
        • NHS Grampian
        • Contact:
        • Principal Investigator:
          • Angus Macleod
      • Barnsley, United Kingdom, S75 2EP
        • Recruiting
        • Barnsley Hospital NHS Foundation Trust
        • Contact:
        • Principal Investigator:
          • Bahaa Madi
      • Bournemouth, United Kingdom, BH23 2JX
        • Recruiting
        • University Hospitals Dorset NHS Foundation Trust
        • Contact:
        • Contact:
          • Emma Gunter
          • Phone Number: 0300 019 5284
        • Principal Investigator:
          • Divya Tiwali
      • Bridgend, United Kingdom, CF31 1RQ
        • Recruiting
        • Princess of Wales Hospital (Cwm Taf Morgannwg University Health Board)
        • Contact:
        • Principal Investigator:
          • Sandip Raha
      • Bristol, United Kingdom, BS10 5NB
        • Recruiting
        • North Bristol NHS Trust
        • Contact:
        • Principal Investigator:
          • Edward Richfield
        • Sub-Investigator:
          • Alan Whone
      • Bristol, United Kingdom, BS1 3NU
        • Recruiting
        • University Hospitals Bristol and Weston NHS Foundation Trust
        • Contact:
        • Principal Investigator:
          • Emma Stratton
      • Bury, United Kingdom, BL9 7TD
        • Recruiting
        • Pennine Acute Hospitals NHS Trust
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jason Raw
      • Derby, United Kingdom, DE22 3NE
        • Recruiting
        • University Hospitals of Derby and Burton NHS Foundation Trust
        • Contact:
        • Principal Investigator:
          • Rob Skelly
      • Dundee, United Kingdom, DD2 1UB
        • Recruiting
        • NHS Tayside
        • Contact:
          • Justine Hudson
        • Principal Investigator:
          • Esther Sammler
      • Gateshead, United Kingdom, NE9 6SX
        • Recruiting
        • Gateshead Health NHS Foundation Trust
        • Contact:
        • Principal Investigator:
          • Claire McDonald
      • Gloucester, United Kingdom, GL1 3NN
        • Recruiting
        • Gloucestershire Hospitals NHS Foundation Trust
        • Contact:
        • Principal Investigator:
          • Sangeeta Kulkarni
      • Leeds, United Kingdom, LS2 3AX
        • Recruiting
        • Leeds Teaching Hospitals NHS Trust
        • Contact:
        • Principal Investigator:
          • Stephen Butterworth
        • Sub-Investigator:
          • Jeremy Cosgrove
      • Leicester, United Kingdom, LE1 5WW
        • Recruiting
        • University Hospitals of Leicester NHS Foundation Trust
        • Contact:
        • Principal Investigator:
          • Kate O'Kelly
      • Liverpool, United Kingdom, L9 7LJ
        • Recruiting
        • The Walton Centre NHS Foundation Trust
        • Contact:
        • Principal Investigator:
          • Michael Bonello
      • London, United Kingdom, W6 8RF
        • Recruiting
        • Imperial College Healthcare NHS Trust
        • Contact:
        • Principal Investigator:
          • Sophie Molloy
      • London, United Kingdom, WC1N 3BG
        • Recruiting
        • University College London Hospitals NHS Foundation Trust
        • Contact:
        • Principal Investigator:
          • Tabish Saifee
      • London, United Kingdom, E9 6SR
        • Withdrawn
        • Homerton University Hospital NHS Foundation Trust
      • Middlesbrough, United Kingdom, TS4 3BS
        • Recruiting
        • South Tees Hospitals NHS Foundation Trust
        • Contact:
        • Principal Investigator:
          • Louise Wiblin
      • Newcastle, United Kingdom, NE27 0QJ
        • Recruiting
        • Northumbria Healthcare NHS Foundation Trust
        • Contact:
        • Principal Investigator:
          • James Fisher
        • Sub-Investigator:
          • Richard Walker
      • Newcastle, United Kingdom, NE7 7DN
        • Recruiting
        • Newcastle Hospitals NHS Foundation Trust
        • Contact:
        • Principal Investigator:
          • Alison Yarnall
      • Newport, United Kingdom, NP18 3XQ
        • Recruiting
        • Aneurin Bevan University Health Board
        • Contact:
        • Principal Investigator:
          • Alistair Church
      • Oxford, United Kingdom, OX3 9DU
        • Recruiting
        • Oxford University Hospitals
        • Contact:
        • Principal Investigator:
          • Sanja Thompson
      • Peterborough, United Kingdom, PE3 9GZ
        • Recruiting
        • North West Anglia NHS Foundation Trust
        • Contact:
        • Principal Investigator:
          • Henry ALDORADIN CABEZA
      • Plymouth, United Kingdom, PL6 5FP
        • Recruiting
        • University Hospitals Plymouth NHS Trust
        • Contact:
        • Principal Investigator:
          • Camille Carroll
      • Preston, United Kingdom, PR2 9HT
        • Recruiting
        • Lancashire Teaching Hospitals NHS Foundation Trust
        • Contact:
      • Reading, United Kingdom, RG1 5AN
        • Recruiting
        • Royal Berkshire NHS foundation trust
        • Contact:
        • Principal Investigator:
          • Apurba Chatterjee
      • Salford, United Kingdom, MA6 8HD
        • Recruiting
        • Salford Royal NHS Foundation Trust
        • Contact:
        • Principal Investigator:
          • Christopher Kobylecki
      • Stockton-on-Tees, United Kingdom, TS19 8PE
        • Recruiting
        • North Tees and Hartlepool Hospitals NHS Foundation Trust
        • Contact:
        • Principal Investigator:
          • Arunkumar Annamalai
      • Taunton, United Kingdom, TA1 5DA
        • Recruiting
        • Somerset NHS Foundation Trust
        • Contact:
        • Principal Investigator:
          • Anita Goff
        • Sub-Investigator:
          • Sarah Campbell
      • Wigan, United Kingdom, WN1 2NN
        • Recruiting
        • Wrightington, Wigan and Leigh Teaching Hospitals NHS Foundation Trust
        • Contact:
        • Principal Investigator:
          • Steve Adejumo
      • Wrexham, United Kingdom, LL13 7YP
        • Recruiting
        • Betsi Cadwaladr University Health Board
        • Contact:
        • Sub-Investigator:
          • Sally Jones
      • Yeovil, United Kingdom
        • Recruiting
        • Yeovil District Hospital
        • Contact:
        • Principal Investigator:
          • Rani Sophia
    • Accepted
      • Romford, Accepted, United Kingdom, BS8 1NU
        • Recruiting
        • Barking, Havering and Redbridge University Hospitals NHS Trust
        • Contact:
        • Principal Investigator:
          • Anjum Misbadhuddin
    • England
      • Manchester, England, United Kingdom, M13 9WL
    • Gwynedd
      • Bangor, Gwynedd, United Kingdom, LL57 2PW
        • Recruiting
        • Betsi Cadwaladr University Health Board
        • Contact:
        • Principal Investigator:
          • Sam Abraham
    • Norfolk
      • Norwich, Norfolk, United Kingdom, NR4 7UY
        • Recruiting
        • Norfolk and Norwich University Hospital
        • Contact:
        • Principal Investigator:
          • Alagaratnam Niruban
    • Scotland
    • Somerset
      • Bath, Somerset, United Kingdom, BA1 3NG
        • Recruiting
        • Royal United Hospitals Bath NHS Foundation Trust
        • Contact:
        • Contact:
          • Veronica Lyell

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fall rate
Time Frame: 12 months from the day the IMP is commenced
Fall rate measured using monthly diaries and telephone calls prospectively
12 months from the day the IMP is commenced

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Parkinson's Disease (PD)
Time Frame: 12 months
MDS-UPDRS total score in the practically defined 'ON' state and each individual subscale (1-4)
12 months
Freezing of gait
Time Frame: 12 months
New Freezing of Gait Questionnaire (NFOGQ)
12 months
Frailty
Time Frame: 12 months
Frailty assessed by the SHARE-FI
12 months
Physical performance
Time Frame: 12 months
Measured by the Short physical performance battery (SPPB)
12 months
Freezing of Gait Assessment
Time Frame: 12 months
Gait speed measured with Freezing of Gait (turn test)
12 months
Gait Assessment
Time Frame: 12 months
Gait speed measured with and without dual task
12 months
Cognition
Time Frame: 12 months
Montreal Cognitive Assessment (MoCA)
12 months
Depression
Time Frame: 12 months
Geriatric Depression Scale (GDS)
12 months
Fear of falling
Time Frame: 12 months
Iconographical Fall Efficacy Scale (ICON-FES)
12 months
Dysphagia
Time Frame: 12 months
Swallowing Disturbance Questionnaire (SDQ)
12 months
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)
0,1,3,6 9 and 12 months
Capability of older people
Time Frame: 12 months
ICEpop CAPability measure for Older people (ICECAP-O)
12 months
Mortality (all cause and PD-related)
Time Frame: 12 months
Office of National Statistics (ONS) data
12 months
Cost effectiveness by NHS resource use
Time Frame: 12 months
NHS Hospital Episode Statistics (HES) data
12 months
Apathy
Time Frame: 12 months
Starkstein Apathy Scale
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Bristol

Collaborators

Royal United Hospitals Bath NHS Foundation Trust

Investigators

  • Principal Investigator: Emily Henderson, PhD, University of Bristol

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 2, 2020

Primary Completion (Anticipated)

August 30, 2023

Study Completion (Anticipated)

November 30, 2023

Study Registration Dates

First Submitted

December 5, 2019

First Submitted That Met QC Criteria

January 8, 2020

First Posted (Actual)

January 13, 2020

Study Record Updates

Last Update Posted (Actual)

January 18, 2023

Last Update Submitted That Met QC Criteria

January 17, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Study 2018-2030

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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