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

Sponsor
University of Bristol (Other)
Overall Status
Recruiting
CT.gov ID
NCT04226248
Collaborator
Royal United Hospitals Bath NHS Foundation Trust (Other)
600
Enrollment
27
Locations
2
Arms
39.9
Anticipated Duration (Months)
22.2
Patients Per Site
0.6
Patients Per Site Per Month

Study Details

Study Description

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
  • Drug: Rivastigmine Transdermal System
  • Other: Placebo Transdermal System
 Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
600 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
A Phase III Randomised Controlled Trial of Rivastigmine versus PlaceboA 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 :
Jan 2, 2020
Anticipated Primary Completion Date :
Apr 30, 2022
Anticipated Study Completion Date :
Apr 30, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Fall rate [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) [12 months]

    MDS-UPDRS total score in the practically defined 'ON' state and each individual subscale (1-4)

  2. Freezing of gait [12 months]

    New Freezing of Gait Questionnaire (NFOGQ)

  3. Frailty [12 months]

    Frailty assessed by the SHARE-FI

  4. Physical performance [12 months]

    Measured by the Short physical performance battery (SPPB)

  5. Freezing of Gait Assessment [12 months]

    Gait speed measured with Freezing of Gait (turn test)

  6. Gait Assessment [12 months]

    Gait speed measured with and without dual task

  7. Cognition [12 months]

    Montreal Cognitive Assessment (MoCA)

  8. Depression [12 months]

    Geriatric Depression Scale (GDS)

  9. Fear of falling [12 months]

    Iconographical Fall Efficacy Scale (ICON-FES)

  10. Dysphagia [12 months]

    Swallowing Disturbance Questionnaire (SDQ)

  11. Participant health related quality of life [0,1,3,6 9 and 12 months]

    EuroQoL 5D-5L health status questionnaire (EQ-5D-5L)

  12. Capability of older people [12 months]

    ICEpop CAPability measure for Older people (ICECAP-O)

  13. Mortality (all cause and PD-related) [12 months]

    Office of National Statistics (ONS) data

  14. Cost effectiveness by NHS resource use [12 months]

    NHS Hospital Episode Statistics (HES) data

  15. Apathy [12 months]

    Starkstein Apathy Scale

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Barking, Havering and Redbridge University Hospitals NHS trust Romford Accepted United Kingdom BS8 1NU
2 Betsi Cadwaladr University Health Board Bangor Gwynedd United Kingdom LL57 2PW
3 Norfolk and Norwich University Hospital Norwich Norfolk United Kingdom NR4 7UY
4 Royal United Hospitals Bath NHS Foundation Trust Bath Somerset United Kingdom BA1 3NG
5 Barnsley Hospital NHS Foundation Trust Barnsley United Kingdom S75 2EP
6 University Hospitals Dorset NHS Foundation Trust Bournemouth United Kingdom BH23 2JX
7 Princess of Wales Hospital (Cwm Taf Morgannwg University Health Board) Bridgend United Kingdom CF31 1RQ
8 North Bristol NHS Trust Bristol United Kingdom BS10 5NB
9 Pennine Acute Hospitals NHS Trust Bury United Kingdom BL9 7TD
10 University Hospitals of Derby and Burton NHS Foundation Trust Derby United Kingdom DE22 3NE
11 Gateshead Health NHS Foundation Trust Gateshead United Kingdom NE9 6SX
12 Gloucestershire Hospitals NHS Foundation Trust Gloucester United Kingdom GL1 3NN
13 Leeds Teaching Hospitals NHS Trust Leeds United Kingdom LS2 3AX
14 University Hospitals of Leicester NHS Foundation Trust Leicester United Kingdom LE1 5WW
15 The Walton Centre NHS Foundation Trust Liverpool United Kingdom L9 7LJ
16 Homerton University Hospital NHS Foundation Trust London United Kingdom E9 6SR
17 Imperial College Healthcare NHS Trust London United Kingdom W6 8RF
18 University College London Hospitals NHS Foundation Trust London United Kingdom WC1N 3BG
19 Northumbria Healthcare NHS Foundation Trust Newcastle United Kingdom NE27 0QJ
20 Oxford University Hospitals Oxford United Kingdom OX3 9DU
21 University Hospitals Plymouth NHS Trust Plymouth United Kingdom PL6 5FP
22 Lancashire Teaching Hospitals NHS Foundation Trust Preston United Kingdom PR2 9HT
23 Salford Royal NHS Foundation Trust Salford United Kingdom MA6 8HD
24 Somerset NHS Foundation Trust Taunton United Kingdom TA1 5DA
25 Wrightington, Wigan and Leigh Teaching Hospitals NHS Foundation Trust Wigan United Kingdom WN1 2NN
26 Betsi Cadwaladr University Health Board Wrexham United Kingdom LL13 7YP
27 Yeovil District Hospital Yeovil United Kingdom

Sponsors and Collaborators

  • University of Bristol
  • Royal United Hospitals Bath NHS Foundation Trust

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Bristol
ClinicalTrials.gov Identifier:
NCT04226248
Other Study ID Numbers:
  • Study 2018-2030
First Posted:
Jan 13, 2020
Last Update Posted:
Dec 23, 2021
Last Verified:
Dec 1, 2021
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:
Parkinson Disease
Rivastigmine

Study Results

No Results Posted as of Dec 23, 2021